Location: United States
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Project Director (PD) to join our A-team (office-based*/remote). As a PD at Allucent, you are responsible for overseeing operational project teams, customer satisfaction and continuous improvement of processes within the Global Clinical Operations (GCO) department. This position controls and monitors the quality and full-service delivery of clinical trial Allucent customers.
About this role:
As a proactive project director, you will:
Oversee the project
and be responsible for the overall quality and management of the deliver clinical trial projects and programs. This includes overseeing the budget, reviewing and approving content and costing of proposals, problem solving with project teams, and balancing multiple competing priorities.
Serve as the key contact for assigned clients
on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs.
Lead the project team.
You will demonstrate knowledge of and insight into general business principles and practices, demonstrate a growth mindset, and support the recruitment and interviewing of new employees.
Requirements
To be successful, you will posess:
Minimum Bachelor’s degree in life science, healthcare and/or business degree; Master’s degree or greater preferred
Minimum 8 years of relevant work experience, specifically experience in drug development and/or clinical research ; CRA experience preferred.
Minimum 8 years of project management experience, specifically as a clinical project manager ; managing global clinical trials required
Extensive clinical project management experience, with at least 5 years of clinical project management experience
Expert knowledge of ICH-GCP(R3), data and patient privacy practices, and applicable (local) regulatory requirements
Strong financial acumen, administrative excellence and analytical skills
In some cases, an equivalency—consisting of a combination of appropriate education, training, and/or directly related experience—will be considered appropriate for an individual to meet the requirements of this role
Therapeutic expertise in Oncology required
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Disclaimers:
*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Remote #LI-Hybrid #LI-TCW
Location: Amsterdam, Netherlands; Scherpenheuvel, Belgium
About Allucent™
At Allucent™, our mission is to shine a light on new therapies that improve lives. When you join our team, you’ll use your unique skills, expertise, and knowledge to forge meaningful partnerships with clients while helping them turn groundbreaking ideas into life-changing treatments.
If you’re passionate about advancing pharmaceuticals and biologics, fueled by an entrepreneurial spirit, and eager to collaborate with top minds across science, business, and operations, we’d love to connect. Together we can accelerate innovation and grow side by side, making a last impact on patients worldwide.
Together we
SHINE
. Find more information about our values.
The role
Bring your monitoring expertise to the forefront of innovation.
We are looking for a
Clinical Research Associate (CRA)
to join our A-team. As a CRA at Allucent™, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
As a
CRA
, you will take the lead on monitoring activities, owning your sites and relationships with investigators. You’ll be the bridge between sponsor and site, ensuring trial integrity while being supported by a collaborative, experienced team. This includes work related to regulatory affairs, site activation processes—including contracting and start-up activities—to ensure smooth and compliant study execution. You will travel throughout Netherlands and/or Belgium.
Main responsibilities:
Independently manage all aspects
of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
Ensure compliance
with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
Build strong site relationships
, acting as a primary point of contact and ensuring high-quality data collection.
Identify and resolve site issues
, escalating as needed to maintain trial integrity and patient safety.
Activities around
regulatory affairs, site activation
and
study-startup.
Requirements
To be successful you will possess:
You’re an experienced CRA ready to take the next step with a company that truly values your expertise and independence. You thrive in an agile, collaborative environment and want to be part of a team making a real impact.
Experience in leading monitoring activities in complex trials with a minimum of 2 years’ experience.
Strong understanding of
ICH-GCP
and
regulatory guidelines
.
Clear and confident communicator in
English
and
Dutch.
Comfortable working independently and managing priorities.
Willingness to travel, as required (8 DOS per month).
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1
Location: United Kingdom; Spain; Netherlands; Switzerland; France; Italy
Step into a role where science meets strategy and your expertise shapes the future of drug development. As a Director, Pharmacometrician, you’ll lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment. You’ll guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones. This role also offers the opportunity to represent clients in interactions with regulatory agencies. If you thrive on collaboration and solving complex scientific challenges, this is your chance to make a meaningful impact.
About the role
This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement.
Your main responsibilities will include but not limited to:
Lead and conduct population PK analyses using advanced modeling tools and methodologies
Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
Author and review PK reports and clinical pharmacology sections of regulatory documents
Represent clients in regulatory interactions and contribute to business development and relationship management
Requirements
About You
If you are a driven clinical pharmacology professional with 6–10 years of experience in drug development and pharmacometrics and you bring sharp analytical thinking and expertise in tools like NONMEM, Pirana, and R to deliver high-impact insights while being client-focused and a natural leader who thrives in fast-paced environments, combining strategic thinking, strong communication, and business acumen to build relationships and drive results, this role is for you.
To be successful we are looking for the following traits and behaviors:
Life science, healthcare and/or business degree
Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions
Proficiency in NONMEM, Pirana, and R software preferred
Excellent organizational, negotiating and financial skills
Benefits
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. Find more information about our values.
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Apply now!
If you are interested in this role please apply through the button or for more information reach out to Demetria Eggleston at
Demetria.eggleston@allucent.com
Salary:
United Kingdom:
£82,000K-111,000K
Disclaimers:
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Remote #LI-Hybrid #LI-DE
Location: United Kingdom; Ireland
Step into a leadership role where your expertise drives innovation. As a
Director, Regulatory Affairs
, you’ll guide clients through the complexities of drug, biologic, and medical device development. Leading teams, shaping strategies, and ensuring successful submissions. This is your chance to be the trusted expert who turns regulations into real-world impact on global healthcare.
About the Role
As a Director of Regulatory Affairs, you will guide clients through the complexities of drug, biologic, and medical device development. You will lead and mentor regulatory teams, shape strategies, and ensure the delivery of high-quality, scientifically sound submissions. You will serve as a trusted expert in Health Authority (HA) interactions and translate regulatory requirements into clear, actionable plans. In this role, you will act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams. You will also review and author regulatory and scientific documents while driving successful outcomes for clients. Most importantly, you will make a direct impact on advancing innovative therapies and global healthcare.
Your main responsibilities will include but not limited to:
Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
Reviews and prepares HA meeting requests and briefing documents.
Oversees and manages regulatory projects of varying complexities.
Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
Has advanced knowledge of CTD format and structure for regulatory submissions.
Requirements
About You
If you are a strategic leader with deep regulatory expertise across both pre-and-post marketing stages of development and thrive on leading regulatory projects, solving complex regulatory challenges, and making a tangible impact on global healthcare, you’ll thrive here.
To be successful we are looking for the following traits and behaviors:
Requires a B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
8 years’ experience with regulatory requirements of US FDA, Health Canada and / or European authorities
Advanced regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU, and / or Canada
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. Find more information about our values.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Apply now!
If you are interested in this role please apply through the button or for more information reach out to Demetria Eggleston at Demetria.eggleston@allucent.com
Salary:
United Kingdom:
£90,000K-122,000K
Ireland:
€116,000K-156,000K
Disclaimers:
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."
#LI-DE1
#LI-Remote
Location: United States
Step into a role where science meets strategy and your expertise shapes the future of drug development. As a Director, Pharmacometrician, you’ll lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment. You’ll guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones. This role also offers the opportunity to represent clients in interactions with regulatory agencies. If you thrive on collaboration and solving complex scientific challenges, this is your chance to make a meaningful impact.
About the role
This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement.
Your main responsibilities will include but not limited to:
Lead and conduct population PK analyses using advanced modeling tools and methodologies
Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
Author and review PK reports and clinical pharmacology sections of regulatory documents
Represent clients in regulatory interactions and contribute to business development and relationship management
Requirements
About You
If you are a driven clinical pharmacology professional with 6–10 years of experience in drug development and pharmacometrics and you bring sharp analytical thinking and expertise in tools like NONMEM, Pirana, and R to deliver high-impact insights while being client-focused and a natural leader who thrives in fast-paced environments, combining strategic thinking, strong communication, and business acumen to build relationships and drive results, this role is for you.
To be successful we are looking for the following traits and behaviors:
Life science, healthcare and/or business degree
Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions
Proficiency in NONMEM, Pirana, and R software preferred
Excellent organizational, negotiating and financial skills
Benefits
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. Find more information about our values.
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Apply now!
If you are interested in this role please apply through the button or for more information reach out to Demetria Eggleston at
Demetria.eggleston@allucent.com
Disclaimers:
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Remote #LI-Hybrid #LI-DE
Location: Montreal, Canada
Rejoignez un poste où la science rencontre la stratégie et où votre expertise façonne l’avenir du développement de médicaments. En tant que
Directeur pharmacométricien
, vous dirigerez des projets de modélisation et de simulation à fort impact au sein d’un environnement dynamique de pharmacologie clinique, de modélisation et de simulation (CPMS). Vous dirigerez des équipes, encadrerez des pharmacométriciens et fournirez des conseils stratégiques aux clients lors des étapes clés du développement. Ce poste vous offre également l’opportunité de représenter les clients dans leurs interactions avec les organismes de réglementation. Si vous aimez travailler en collaboration et relever des défis scientifiques complexes, voici votre chance d’avoir un impact significatif.
Step into a role where science meets strategy and your expertise shapes the future of drug development. As a
Director Pharmacometrician
, you’ll lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment. You’ll guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones. This role also offers the opportunity to represent clients in interactions with regulatory agencies. If you thrive on collaboration and solving complex scientific challenges, this is your chance to make a meaningful impact.
À propos du poste
Ce poste allie leadership scientifique et impact stratégique : vous dirigerez des analyses pharmacocinétiques de population tout en développant des approches innovantes pour à améliorer l’efficacité et la précision. Vous serez chargé de concevoir, d’analyser et d’interpréter des études de pharmacologie clinique, de fournir des conseils stratégiques aux clients et de contribuer à la rédaction de documents réglementaires ainsi qu’aux interactions avec les organismes de réglementation. De plus, vous entretiendrez les relations avec les clients, soutiendrez le développement des affaires et resterez à la pointe des avancées en pharmacocinétique et pharmacodynamique afin de favoriser l’amélioration continue.
Vos principales responsabilités comprendront, sans s'y limiter :
Diriger et réaliser des analyses pharmacocinétiques de population à l'aide d'outils et de méthodologies de modélisation avancés
Élaborer et mettre en œuvre des approches innovantes pour améliorer l'efficacité et la précision des analyses pharmacocinétiques
Concevoir, analyser et interpréter des études de pharmacologie clinique (rénale, hépatique, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) et fournir des conseils pour optimiser les stratégies d'échantillonnage pharmacocinétique et de posologie
Fournir des conseils stratégiques aux clients, en assumant la responsabilité des livrables et en élaborant des plans de pharmacologie clinique
Rédiger et réviser les rapports pharmacocinétiques ainsi que les sections de pharmacologie clinique des documents réglementaires
Représenter les clients dans les interactions avec les autorités réglementaires et contribuer au développement des affaires et à la gestion des relations
About the role
This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement.
Your main responsibilities will include but not limited to:
Lead and conduct population PK analyses using advanced modeling tools and methodologies
Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
Author and review PK reports and clinical pharmacology sections of regulatory documents
Represent clients in regulatory interactions and contribute to business development and relationship management
Requirements
À propos de vous
Si vous êtes un professionnel de la pharmacologie clinique motivé, fort de 10 ans d’expérience dans le développement de médicaments et la pharmacométrie, et que vous possédez un esprit analytique aigu ainsi qu’une expertise dans l’utilisation d’outils tels que NONMEM, Pirana et R pour fournir des analyses percutantes, tout en étant orienté vers le client et en étant un leader naturel qui s’épanouit dans des environnements dynamiques, alliant réflexion stratégique, excellentes compétences en communication et sens des affaires pour établir des relations et obtenir des résultats, ce poste est fait pour vous.
Pour réussir, nous recherchons les qualités et comportements suivants :
Diplôme en sciences de la vie, en soins de santé et/ou en administration des affaires
Au moins 10 ans d’expérience professionnelle pertinente, notamment dans le développement de médicaments, la pharmacologie clinique et la pharmacométrie
Une expérience en matière de réglementation, y compris la rédaction de rapports réglementaires, est indispensable. Expérience des soumissions réglementaires, y compris les demandes d'autorisation de mise en examen (IND), les demandes d'autorisation de clinique (CTA), les réunions réglementaires et les soumissions de demandes d'autorisation de mise en marché (NDA/BLA/MAA)
Maîtrise des logiciels NONMEM, Pirana et R souhaitée
Excellentes compétences en organisation, en négociation et en gestion financière
About You
If you are a driven clinical pharmacology professional with 10 years of experience in drug development and pharmacometrics and you bring sharp analytical thinking and expertise in tools like NONMEM, Pirana, and R to deliver high-impact insights while being client-focused and a natural leader who thrives in fast-paced environments, combining strategic thinking, strong communication, and business acumen to build relationships and drive results, this role is for you.
To be successful we are looking for the following traits and behaviors:
Life science, healthcare and/or business degree
Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions
Proficiency in NONMEM, Pirana, and R software preferred
Excellent organizational, negotiating and financial skills
Benefits
À propos d'Allucent
Notre mission est de contribuer à la mise au point de nouveaux traitements. Travailler chez Allucent, c'est retrousser ses manches et mettre à profit ses compétences, son expertise et ses connaissances uniques pour établir des partenariats avec nos clients dans leur quête de nouveaux traitements destinés à améliorer la vie des patients.
Si vous êtes passionné(e) par l'aide apportée aux clients pour le développement de nouveaux produits pharmaceutiques et biologiques, si vous avez l'esprit d'entreprise et si vous êtes prêt(e) à rejoindre d'autres leaders dans les domaines de la science, des affaires et des opérations, nous serions ravis d'en savoir plus sur la manière dont nous pouvons nous aider mutuellement à grandir.
Ensemble, nous BRILLONS. Découvrez-en plus sur nos valeurs.
Les avantages de travailler chez Allucent comprennent :
Ensemble complet d'avantages sociaux par site
Des salaires compétitifs par site
Un budget départemental dédié à la formation et à l'étude pour favoriser le développement professionnel
Des horaires de travail flexibles (dans la mesure du raisonnable)
La possibilité de travailler télétravail/en mode hybride* selon le site
Possibilités de leadership et de mentorat
Participation à notre programme de parrainage en tant que nouvel employé ou employé existant
Des opportunités d'évolution interne et de progression de carrière
Programme de recommandation interne des employés financièrement avantageux
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. Find more information about our values.
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Avertissements :
*Notre politique de travail au bureau encourage un environnement de travail dynamique, en prescrivant un minimum de 2 jours par semaine au bureau pour les employés se trouvant à une distance raisonnable de l'un de nos
bureaux internationaux
.
L'équipe Allucent Talent Acquisition gère le processus de recrutement et d'embauche pour Allucent (US) LLC et ses filiales (collectivement « Allucent »). Allucent n'accepte pas les CV non sollicités provenant de recruteurs tiers ni les demandes de collaboration non sollicitées pour l'un de nos postes vacants. Les CV non sollicités envoyés aux employés d'Allucent n'obligent pas Allucent à embaucher ces personnes à l'avenir ni à verser une rémunération potentielle à une agence de recrutement tierce. Les candidatures ne doivent jamais être soumises directement à nos responsables du recrutement, à nos employés ou à nos services des ressources humaines.
Disclaimers:
*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Remote #LI-Hybrid #LI-DE
Location: Bengaluru, India
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Senior Clinical Data Manager I (SrCDM1) leads data management activities of the Allucent Data Management (DM) department.
This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting.
This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.
The SrCDM1 provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings.
The SrCDM1 is a member of the Data Management staff.
Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
Plan and project the resources required including management of tasks, timelines, risk and quality
Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition.
Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements
Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)
Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed
Create training materials for EDC users and provide project-specific training as required
Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
Plan and project the resources required including management of tasks, timelines, risk and quality
Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition.
Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements
Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)
Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed
Create training materials for EDC users and provide project-specific training as required
Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness
Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance
Organize and lead Quality Review activities during stud
Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)
Manage the database maintenance, lock and close-out processes and procedure
Participate in conference calls and/or meetings with vendors and sponsors
Recognize and solve potential problems and evaluate effectiveness
Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
Help to align data management and clinical programming best practices, standards and conventions within the company
Provide leadership, expertise and support to other department members.
Propose and support initiatives for improving efficiency
Actively support to staff learning & development within the company
Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions
Represent the company at professional meetings, webinars or seminars
Train and mentor data management staff, support in development of new training material and provide training to relevant staff
Participate in the interview process for new recruits
Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes
Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System
Assure good communication and relationships with (future) clients
Contribute to and take part in client evaluations and visits
Support in preparation of new proposals and budgets for Data Management services
Requirements
Life science, healthcare degree and/or combination of education and experience
Minimum 5 years of relevant work experience as Clinical Data Manager
Minimum 5 years of experience in drug development and/or clinical research
Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements
Good understanding of Medical Terminology
Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA
Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock).
Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation
Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models
Experience in developing data management standards
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via GoodHabitz and internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we
SHINE.
find more information about our values.
Apply now!
If you’re ready to bring your passion for clinical development and business growth to Allucent, apply today or reach out to Monica Grace (monica.grace@allucent.com) for more information.
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
Kindly share your CV to monica.grace@allucent.com
Location: Montreal, Canada
Chez Allucent™, nous nous engageons à aider les petites et moyennes entreprises biopharmaceutiques à naviguer efficacement dans l’univers complexe des essais cliniques afin d’offrir des traitements qui changent la vie aux patients qui en ont besoin partout dans le monde.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Nous recherchons un
directeur médical adjoint
pour rejoindre notre équipe d’élite (télétravail). En tant que directeur médical adjoint chez Allucent, vous serez chargé de veiller, de manière autonome, à l’intégrité et à la qualité des aspects médicaux, cliniques et de sécurité des essais menés par Allucent. Vous servirez de personne-ressource en tant que moniteur médical dans les protocoles d’étude auprès des chercheurs et des équipes des centres d’étude pour toute question relative au protocole et à la sécurité des participants recrutés. Une expérience en
oncologie
est obligatoire pour ce poste.
We are looking for an
Associate Medical Director
to join our A-team (remote). As an Associate Medical Director at Allucent, you are responsible for working independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent, serving as the medical monitor contact in study protocols to investigators and study sites team regarding protocol related questions and safety of the subjects enrolled. Experience in
Oncology
is a requirement for this position.
Dans le cadre de ce poste, vos principales tâches consisteront à:
Fournir de manière autonome un soutien en matière de surveillance médicale aux études cliniques qui vous sont attribuées, par exemple en répondant aux questions d’ordre médical posées par l’équipe de l’étude et/ou le site, en aidant à l’interprétation du protocole et à l’examen médical des données générées, y compris, mais sans s’y limiter, les données de laboratoire clinique et les formulaires de rapport de cas, selon les besoins, afin de garantir le respect du protocole, la cohérence et la validité scientifique des données. Au besoin, et avec l’appui nécessaire de ses supérieurs, aider le gestionnaire de projet dans les discussions avec les clients concernant les questions ou les préoccupations liées à la sécurité qui pourraient avoir été soulevées.
Préparer les plans de surveillance médicale et autres plans pertinents pour les études assignées menées par Allucent avant le début de l’étude et conformément aux livrables prévus dans le contrat.
Examiner les événements indésirables graves, les SUSAR, les rapports de sécurité et effectuer l’analyse des événements similaires.
Assister l’équipe de gestion des données cliniques dans le codage MedDRA et OMS pour les essais assignés.
Contribuer à l’examen des documents relatifs aux études cliniques afin d’en vérifier la cohérence et la pertinence sur le plan médical, avec l’appui des membres chevronnés de l’équipe médicale au besoin, notamment, mais sans s’y limiter, le protocole d’essai clinique (CTP), le formulaire de consentement éclairé (ICF) et le rapport d’étude clinique (CSR), ainsi que d’autres rapports sur l’innocuité (p. ex., DSUR, PSUR)
Contribuer à la mise en place et à la conduite des comités de sécurité des données (DSMB, DMB ou équivalents) et des réunions d’augmentation de la dose (DEC)
Assister, participer et faire des présentations lors de la réunion de lancement, de la réunion des chercheurs et d’autres réunions pertinentes dans le cadre des projets attribués, selon les besoins.
Fournir un soutien médical d’urgence 24 heures sur 24, 7 jours sur 7, pour des conseils médicaux et de sécurité, au besoin
Assurer la formation des équipes de projet sur les aspects médicaux de l’essai et la formation thérapeutique, au besoin
Examen des écarts par rapport au protocole
Cerner les risques liés à l’étude et contribuer à l’élaboration du plan de gestion des risques
Examiner et comprendre les livrables médicaux de l’étude tels qu’ils sont définis dans le contrat de l’étude assignée, avec l’appui de collègues plus expérimentés, et contribuer au suivi des dépenses budgétaires tout au long des études qui leur sont confiées
Assiste à d’importantes conférences sur les traitements thérapeutiques et le développement de médicaments, et peut être amené à y faire une présentation
Assure une bonne communication et entretient de bonnes relations avec les (futurs) clients
Contribue et participe, avec le soutien de collègues plus expérimentés si nécessaire, aux évaluations des clients, aux visites et aux présentations d’offres
In this role your key tasks will include:
Independently provide medical monitor support to assigned clinical studies, for example answering medical questions from study team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen
Prepare the Medical Monitoring and other relevant plans for assigned studies conducted by Allucent prior to the start of the study and in accordance to deliverables contracted.
Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
Assist clinical data management with MedDRA and WHO coding in assigned trials
Assist by reviewing clinical study documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol (CTP), the Informed Consent (ICF) and clinical study report (CSR) other safety reports (e.g., DSUR, PSUR)
Assist in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
Attend, participate and present in Kick-Off, Investigators’ meeting, and other relevant meetings in assigned projects, as requested.
Provide 24/7 urgent medical support for medical and safety advice if required
Training of project teams on medical aspects of the trial and therapeutic training as required
Review of Protocol Deviations
Identify study risks and provide input to the Risk plan
Review and understand study medical deliverables laid down in the assigned study’s contract with support of senior colleagues and help track budget spent throughout their assigned study(ies)
Attends and may need to present at major therapeutic conferences and drug development conferences
Assure good communication and relationships with (future) clients
Contribute and take part with support from senior colleagues as needed in client evaluations, visits and bid defenses
Requirements
Pour réussir dans ce poste, vous devrez posséder :
Un diplôme de docteur en médecine (MD)
Expérience en tant qu’oncologue
au moins trois ans d’expérience professionnelle pertinente, avec une solide expertise en oncologie
Une bonne connaissance des normes GxP
Une situation en règle auprès des autorités de réglementation et d’agrément locales, provinciales (aux États-Unis) et nationales, ainsi qu’auprès des organismes de certification
Connaissance des exigences réglementaires applicables (locales), notamment celles du RGPD/HIPAA, du CFR/CTR/CTD
Excellentes compétences en communication écrite et verbale, y compris une bonne maîtrise de l’anglais
Présentable, extraverti et axé sur le client
Capacité à travailler dans l’environnement dynamique et stimulant d’une entreprise en pleine croissance
Excellence administrative
Maîtrise requise de divers logiciels tels que Word, Excel et PowerPoint
To be successful you will possess:
MD degree
Experience as an Oncologist
Minimum 3 years of relevant work experience with solid Oncology expertise
Good knowledge of GxP
Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements understanding
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Benefits
Voici quelques-uns des avantages liés au fait de travailler chez Allucent :
Ensemble complet d’avantages sociaux selon le lieu de travail
Salaires concurrentiels selon le lieu de travail
Budget de formation et d’études alloué par service pour favoriser le perfectionnement professionnel
Horaires de travail flexibles (dans la mesure du raisonnable)
Possibilité de travail à distance ou hybride* selon le lieu de travail
Possibilités d’accéder à des postes de direction et de bénéficier d’un mentorat
Participation à notre programme de jumelage, que ce soit en tant que nouvel employé ou employé déjà en poste
Possibilités d’évolution interne et de progression de carrière
Programme de recommandation de candidats par les employés, financièrement avantageux
Accès à des formations en ligne sur les compétences générales et techniques via ADP et nos plateformes internes
Admissibilité à notre programme de primes ponctuelles, qui récompense les efforts exceptionnels déployés dans le cadre de projets
Admissibilité à notre programme de récompenses de fidélité, qui reconnaît la loyauté et l’engagement des employés de longue date
Avertissements :
*Notre politique de travail hybride favorise un milieu de travail dynamique et prévoit deux journées de présence au bureau par semaine pour les employés résidant à une distance raisonnable de l’un de nos bureaux à l’échelle mondiale.
"L’équipe de recrutement d’Allucent gère le processus de recrutement et d’embauche pour Allucent (US) LLC et ses sociétés affiliées (collectivement « Allucent »). Allucent n’accepte pas les CV non sollicités provenant de recruteurs tiers ni les demandes de collaboration non sollicitées concernant l’un de nos postes vacants. L’envoi de CV non sollicités à des employés d’Allucent n’engage en aucun cas Allucent à embaucher ces personnes à l’avenir ni à verser une rémunération à une agence de recrutement tierce. « Les candidats ne doivent en aucun cas être présentés directement à nos responsables de l'embauche, à nos employés ou au service des ressources humaines."
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via ADP and internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-DE #LI-Remote
Location: Poland; Finland; Australia; South Africa; Germany; Estonia
We’re building a local network of talented PV experts to collaborate with on future projects. We’d love to connect with professionals who are interested in staying in touch for freelance (parttime) opportunities. Let’s start the conversation and build a connection! Currently we are looking to add people to our network in Poland.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of post-marketing regulatory requirements to ensure continued safety and availability of life-changing therapies for patients around the world. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.
The role
The
Local Contact Person for Pharmacovigilance (LCPPV)
coordinates and performs the logistical aspects of pharmacovigilance activities in post-marketed programs to ensure compliance with local requirements. This position controls and monitors operational pharmacovigilance activities and may back-up Pharmacovigilance Manager(s) as required.
Main responsibilities:
Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required
Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class
Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance
Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed
Performs local literature screening and collection of safety information
Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required
Supports local signal detection, if applicable
Manages locally risk minimization measures, as applicable
Reports to and maintains regular communication with the EU QPPV
Supports the review of local PV agreements, if requested
Performs local PV training to eg. sales force, affiliate personnel, distributors
Provides monthly activity report on status of local PV system
Requirements
Who are we looking for:
University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post-marketing activities
Have up-to-date knowledge of applicable global and local regulatory requirements
In-depth knowledge of the pharmacovigilance legal framework in country where LCPPV services are delivered
Fluency in the written and spoken English language
Reside in the country where LCPPV provides services, if required
Benefits
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. Find more information about our values.
Disclaimers:
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
Location: Australia
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Looking to take your project management expertise to the next level? Join us as a
Project Manager II (PM II) / Senior Project Manager (Sr. PM)
and lead the delivery of complex clinical trials that make a meaningful impact for patients worldwide. We are seeking a strategic and execution-focused leader with strong experience managing
multispecialty therapy studies
who thrives in a fast-paced, collaborative environment.
About the Role
As a Project Manager, you will lead with impact and drive global clinical trials from study start-up through final delivery. You’ll oversee cross-functional teams, ensuring studies remain on track, on budget, and compliant with GCP and regulatory requirements while serving as the primary point of contact for sponsors, vendors, and internal stakeholders. With a focus on proactive problem-solving, risk mitigation, and operational excellence, you’ll play a critical role in delivering high-quality clinical programs that exceed client expectations.
Your main responsibilities will include but not limited to:
Driving project success by leading cross-functional teams to deliver clinical trials on time, within scope, and on budget.
Ensuring excellence and compliance by developing and executing project plans aligned with GCP, SOPs, and regulatory standards.
Aligning stakeholders by serving as the primary point of contact for sponsors, vendors, and internal teams.
Optimizing vendor performance through strategic selection, management, and oversight.
Mitigating risks and control budgets by proactively addressing challenges, scope changes, and resource allocation.
Maintaining inspection-ready documentation by leading key meetings and ensuring the Trial Master File and study records are complete.
Requirements
About You
If you are a results-driven Senior Project Manager with a proven track record of leading complex clinical trials from start-up to closeout. If you thrive in fast-paced environments, excel at aligning teams and stakeholders, and take pride in delivering projects on time, on budget, and with uncompromising quality then this role is for you.
To be successful, we are looking for the following traits and behaviors:
Minimum bachelor’s degree in life science, healthcare and/or business degree
PM II:
Minimum 6 years of relevant work experience, specifically experience in drug development and/or clinical research ; Minimum 1 year of project management experience, specifically as a clinical project manager
Sr. PM:
Minimum 6 years of relevant work experience, specifically experience in drug development and/or clinical research ; Minimum 4 years of project management experience, specifically as a clinical project manage
Strong expertise managing the unique operational complexities associated with our Multispecialty ACE Team.
Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
Demonstrates strong financial acumen, administrative excellence and analytical skills
Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out).
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. Find more information about our values.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
Location: Montreal, Canada
Chez Allucent™, nous nous engageons à aider les petites et moyennes entreprises biopharmaceutiques à naviguer efficacement dans l’univers complexe des essais cliniques afin d’offrir des traitements qui changent la vie aux patients qui en ont besoin partout dans le monde.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Nous recherchons un
neurologue certifié
par l'ordre des médecins pour se joindre à notre équipe d'élite (télétravail). En tant que Directeur médical / Directeur médical principal – Neurologue chez Allucent, vous serez chargé de veiller, de manière autonome, à l’intégrité et à la qualité des aspects médicaux, cliniques et de sécurité des essais menés par Allucent. Vous servirez de personne-ressource en tant que moniteur médical dans les protocoles d’étude auprès des chercheurs et des équipes des centres d’étude pour toute question relative au protocole et à la sécurité des participants recrutés. Une expérience en
neurologie
est obligatoire pour ce poste.
We are looking for a
Board-Certified Neurologist
to join our A-team (remote). As an Medical Director/ Sr. Medical Director at Allucent, you are responsible for working independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent, serving as the medical monitor contact in study protocols to investigators and study sites team regarding protocol related questions and safety of the subjects enrolled. Experience in
Neurology
is a requirement for this position.
Dans le cadre de ce poste, vos principales tâches consisteront à:
Fournir de manière autonome un soutien en matière de surveillance médicale aux études cliniques qui vous sont attribuées, par exemple en répondant aux questions d’ordre médical posées par l’équipe de l’étude et/ou le site, en aidant à l’interprétation du protocole et à l’examen médical des données générées, y compris, mais sans s’y limiter, les données de laboratoire clinique et les formulaires de rapport de cas, selon les besoins, afin de garantir le respect du protocole, la cohérence et la validité scientifique des données. Au besoin, et avec l’appui nécessaire de ses supérieurs, aider le gestionnaire de projet dans les discussions avec les clients concernant les questions ou les préoccupations liées à la sécurité qui pourraient avoir été soulevées.
Préparer les plans de surveillance médicale et autres plans pertinents pour les études assignées menées par Allucent avant le début de l’étude et conformément aux livrables prévus dans le contrat.
Examiner les événements indésirables graves, les SUSAR, les rapports de sécurité et effectuer l’analyse des événements similaires.
Assister l’équipe de gestion des données cliniques dans le codage MedDRA et OMS pour les essais assignés.
Contribuer à l’examen des documents relatifs aux études cliniques afin d’en vérifier la cohérence et la pertinence sur le plan médical, avec l’appui des membres chevronnés de l’équipe médicale au besoin, notamment, mais sans s’y limiter, le protocole d’essai clinique (CTP), le formulaire de consentement éclairé (ICF) et le rapport d’étude clinique (CSR), ainsi que d’autres rapports sur l’innocuité (p. ex., DSUR, PSUR)
Contribuer à la mise en place et à la conduite des comités de sécurité des données (DSMB, DMB ou équivalents) et des réunions d’augmentation de la dose (DEC)
Assister, participer et faire des présentations lors de la réunion de lancement, de la réunion des chercheurs et d’autres réunions pertinentes dans le cadre des projets attribués, selon les besoins.
Fournir un soutien médical d’urgence 24 heures sur 24, 7 jours sur 7, pour des conseils médicaux et de sécurité, au besoin
Assurer la formation des équipes de projet sur les aspects médicaux de l’essai et la formation thérapeutique, au besoin
Examen des écarts par rapport au protocole
Cerner les risques liés à l’étude et contribuer à l’élaboration du plan de gestion des risques
Examiner et comprendre les livrables médicaux de l’étude tels qu’ils sont définis dans le contrat de l’étude assignée, avec l’appui de collègues plus expérimentés, et contribuer au suivi des dépenses budgétaires tout au long des études qui leur sont confiées
Assiste à d’importantes conférences sur les traitements thérapeutiques et le développement de médicaments, et peut être amené à y faire une présentation
Assure une bonne communication et entretient de bonnes relations avec les (futurs) clients
Contribue et participe, avec le soutien de collègues plus expérimentés si nécessaire, aux évaluations des clients, aux visites et aux présentations d’offres
In this role your key tasks will include:
Independently provide medical monitor support to assigned clinical studies, for example answering medical questions from study team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen
Prepare the Medical Monitoring and other relevant plans for assigned studies conducted by Allucent prior to the start of the study and in accordance to deliverables contracted.
Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
Assist clinical data management with MedDRA and WHO coding in assigned trials
Assist by reviewing clinical study documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol (CTP), the Informed Consent (ICF) and clinical study report (CSR) other safety reports (e.g., DSUR, PSUR)
Assist in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
Attend, participate and present in Kick-Off, Investigators’ meeting, and other relevant meetings in assigned projects, as requested.
Provide 24/7 urgent medical support for medical and safety advice if required
Training of project teams on medical aspects of the trial and therapeutic training as required
Review of Protocol Deviations
Identify study risks and provide input to the Risk plan
Review and understand study medical deliverables laid down in the assigned study’s contract with support of senior colleagues and help track budget spent throughout their assigned study(ies)
Attends and may need to present at major therapeutic conferences and drug development conferences
Assure good communication and relationships with (future) clients
Contribute and take part with support from senior colleagues as needed in client evaluations, visits and bid defenses
Requirements
Pour réussir dans ce poste, vous devrez posséder :
Un diplôme de docteur en médecine (MD)
Doit être titulaire d’un certificat de spécialité en neurologie
Une expérience en tant que neurologue dans le domaine de la maladie d’Alzheimer et de la maladie de Parkinson, ainsi que d’autres expériences en neurologie et en psychiatrie, constituent des atouts majeurs
au moins cinq-sept ans d’expérience professionnelle pertinente, avec une solide expertise en neurologie
Une bonne connaissance des normes GxP
Une situation en règle auprès des autorités de réglementation et d’agrément locales, provinciales (aux États-Unis) et nationales, ainsi qu’auprès des organismes de certification
Connaissance des exigences réglementaires applicables (locales), notamment celles du RGPD/HIPAA, du CFR/CTR/CTD
Excellentes compétences en communication écrite et verbale, y compris une bonne maîtrise de l’anglais
Présentable, extraverti et axé sur le client
Capacité à travailler dans l’environnement dynamique et stimulant d’une entreprise en pleine croissance
Excellence administrative
Maîtrise requise de divers logiciels tels que Word, Excel et PowerPoint
To be successful you will possess:
MD degree
Must be a Board-Certified Neurologist
Experience as Neurologist with Alzheimer's disease and Parkinson's disease, other neurology and psychiatry experience are key assets
Minimum 5-7 years of relevant work experience with solid Neurology expertise
Good knowledge of GxP
Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements understanding
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Benefits
Voici quelques-uns des avantages liés au fait de travailler chez Allucent :
Ensemble complet d’avantages sociaux selon le lieu de travail
Salaires concurrentiels selon le lieu de travail
Budget de formation et d’études alloué par service pour favoriser le perfectionnement professionnel
Horaires de travail flexibles (dans la mesure du raisonnable)
Possibilité de travail à distance ou hybride* selon le lieu de travail
Possibilités d’accéder à des postes de direction et de bénéficier d’un mentorat
Participation à notre programme de jumelage, que ce soit en tant que nouvel employé ou employé déjà en poste
Possibilités d’évolution interne et de progression de carrière
Programme de recommandation de candidats par les employés, financièrement avantageux
Accès à des formations en ligne sur les compétences générales et techniques via ADP et nos plateformes internes
Admissibilité à notre programme de primes ponctuelles, qui récompense les efforts exceptionnels déployés dans le cadre de projets
Admissibilité à notre programme de récompenses de fidélité, qui reconnaît la loyauté et l’engagement des employés de longue date
Avertissements :
*Notre politique de travail hybride favorise un milieu de travail dynamique et prévoit deux journées de présence au bureau par semaine pour les employés résidant à une distance raisonnable de l’un de nos bureaux à l’échelle mondiale.
"L’équipe de recrutement d’Allucent gère le processus de recrutement et d’embauche pour Allucent (US) LLC et ses sociétés affiliées (collectivement « Allucent »). Allucent n’accepte pas les CV non sollicités provenant de recruteurs tiers ni les demandes de collaboration non sollicitées concernant l’un de nos postes vacants. L’envoi de CV non sollicités à des employés d’Allucent n’engage en aucun cas Allucent à embaucher ces personnes à l’avenir ni à verser une rémunération à une agence de recrutement tierce. « Les candidats ne doivent en aucun cas être présentés directement à nos responsables de l'embauche, à nos employés ou au service des ressources humaines."
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via ADP and internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-DE #LI-Remote
Location: São Paulo, Brazil
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for an
Associate Medical Director/Medical Director
to join our A-team (remote). As an Associate Medical Director at Allucent, you are responsible for working independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent, serving as the medical monitor contact in study protocols to investigators and study sites team regarding protocol related questions and safety of the subjects enrolled. Experience in O
ncology
is a requirement for this position.
In this role your key tasks will include:
Independently provide medical monitor support to assigned clinical studies, for example answering medical questions from study team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen
Prepare the Medical Monitoring and other relevant plans for assigned studies conducted by Allucent prior to the start of the study and in accordance to deliverables contracted.
Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
Assist clinical data management with MedDRA and WHO coding in assigned trials
Assist by reviewing clinical study documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol (CTP), the Informed Consent (ICF) and clinical study report (CSR) other safety reports (e.g., DSUR, PSUR)
Assist in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
Attend, participate and present in Kick-Off, Investigators’ meeting, and other relevant meetings in assigned projects, as requested.
Provide 24/7 urgent medical support for medical and safety advice if required
Training of project teams on medical aspects of the trial and therapeutic training as required
Review of Protocol Deviations
Identify study risks and provide input to the Risk plan
Review and understand study medical deliverables laid down in the assigned study’s contract with support of senior colleagues and help track budget spent throughout their assigned study(ies)
Attends and may need to present at major therapeutic conferences and drug development conferences
Assure good communication and relationships with (future) clients
Contribute and take part with support from senior colleagues as needed in client evaluations, visits and bid defenses
Requirements
To be successful you will possess:
MD degree
Experience as Oncologist
Minimum 3 years of relevant work experience with solid Oncology expertise
Good knowledge of GxP
Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements understanding
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via ADP and internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-DE #LI-Remote
Location: Germany
About Allucent™
At Allucent™, our mission is to shine a light on new therapies that improve lives. When you join our team, you’ll use your unique skills, expertise, and knowledge to forge meaningful partnerships with clients while helping them turn groundbreaking ideas into life-changing treatments.
If you’re passionate about advancing pharmaceuticals and biologics, fueled by an entrepreneurial spirit, and eager to collaborate with top minds across science, business, and operations, we’d love to connect. Together we can accelerate innovation and grow side by side, making a last impact on patients worldwide.
Together we
SHINE
. Find more information about our values.
The role
Bring your monitoring expertise to the forefront of innovation.
We are looking for a
Clinical Research Associate (CRA)
to join our A-team. As a CRA at Allucent™, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
As a
CRA
, you will take the lead on monitoring activities, owning your sites and relationships with investigators. You’ll be the bridge between sponsor and site, ensuring trial integrity while being supported by a collaborative, experienced team. This includes work related to regulatory affairs, site activation processes—including contracting and start-up activities—to ensure smooth and compliant study execution. You will travel throughout Germany.
Main responsibilities:
Independently manage all aspects
of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
Ensure compliance
with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
Build strong site relationships
, acting as a primary point of contact and ensuring high-quality data collection.
Identify and resolve site issues
, escalating as needed to maintain trial integrity and patient safety.
Activities around
regulatory affairs, site activation
and
study-startup.
Requirements
To be successful you will possess:
You’re an experienced CRA ready to take the next step with a company that truly values your expertise and independence. You thrive in an agile, collaborative environment and want to be part of a team making a real impact.
Experience leading monitoring activities in complex trials, ideally in oncology or rare disease with a minimum of at least 5 years’ experience.
Strong understanding of
ICH-GCP
and
regulatory guidelines
.
Clear and confident communicator in
English
and
German.
Comfortable working independently and managing priorities.
Willingness to travel, as required (8 DOS per month).
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1