Вакансии

Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. Who you are Deep expertise in hematopoietic stem cell transplantation (HSCT) and cellular therapy.

55 000 – 90 000 $

Summary of Role: The Director, Case Management will lead the day-to-day operations of Orca Bio’s national case management function supporting TREGZI, our commercially available high-precision stem cell therapy. This individual will oversee a team of existing, high performing Cell Therapy Case Managers and be responsible for ensuring efficient, accurate, and empathetic case coordination across treatment centers. You will play a key role in refining Orca Bio’s post-launch customer service model and scaling the case management infrastructure. This role is a strong fit for someone who thrives in a launch-phase environment and is energized by the opportunity to shape how Orca Bio delivers exceptional customer service as it scales the safe, reliable delivery of TREGZI. Travel Expected: up to 25%, primarily to Orca Bio office locations in the California Bay Area, or customer sites/conferences.

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Responsible for reviewing adverse events and assisting in the determination of regulatory reporting for assigned investigational products. May serve as a liaison to internal and external stakeholders for AE reporting issues (i.e. site staff, CRAs, case processing vendor). Works in collaboration with other functional groups such as data management, clinical operations, regulatory affairs, quality, and medical affairs.

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Position Summary: The Medical Science Liaison (MSL) reports to the Sr. Director, National Field Medical Affairs and is responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will have deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory, and market access considerations. The MSL will serve as a trusted scientific partner between Orca Bio and external healthcare providers (HCPs), establishing strong professional collaborations with investigators and other HCPs within the designated territory (Southern California, Arizona, New Mexico, or Colorado). The MSL will also be an active leader and contributor on projects supporting Medical Affairs Strategic Objectives. Responsibilities: — Serve as a subject matter expert in stem cell transplantation, cell therapy, and cellular immunotherapy, providing scientific insights on treatment paradigms, clinical operations, patient access, and competitive landscape. — Identify, develop, and maintain deep scientific, peer-to-peer relationships with academic stem cell therapy experts, thought leaders, HCPs, and access stakeholders to answer scientific and product-related questions and ensure safe and appropriate use of Orca Bio products. — Prepare and maintain a territory management plan shared with Medical Leadership and internal stakeholders. — Engage with Orca field team members to provide medical support for onboarding activities related to treatment center authorization, adverse event reporting, handling out-of-spec products, and partner with Market Access colleagues to provide medical education and support to local payers. — Maintain a deep and current understanding of hematologic malignancies, stem cell transplantation, cell therapy, cellular immunotherapy, and competitive developments to facilitate high-level scientific exchange. — Assess transplant and cell therapy landscape through engagement with KOLs, investigators, and academic centers to identify scientific trends, evidence gaps, and research opportunities relevant to Orca Bio's therapies. — Serve as primary liaison for Orca Bio's Investigator-Sponsored Trial (IST) program, supporting research concept development, proposal and protocol development, governance communication, and scientific oversight throughout study phases. — Gather and communicate actionable scientific insights and stakeholder feedback to leadership and cross-functional partners to inform medical strategy, evidence generation, and lifecycle planning. — Provide scientific and clinical expertise to support internal and external stakeholders through advisory boards, clinical investigator meetings, educational meetings, professional organizations, advocacy groups, GPOs, and speaker bureaus. — Support clinical trial activities to enhance patient recruitment, enrollment, and discussions on safe and effective use of investigational products, ensuring adherence to Good Clinical Practice (GCP) and regulatory standards. — Lead collection, analysis, synthesis, and dissemination of scientific information from congresses and scientific exchanges, translating data and feedback into actionable recommendations. — Coordinate efforts of other MSLs for congress coverage when assigned. — Provide medical and scientific support for health outcomes, real-world evidence, and payer/provider engagement strategies. — Initiate and autonomously execute projects aligned with Orca Bio’s scientific, clinical, and business operations, partnering with research, clinical development, commercial, market access, regulatory, and quality functions. — Provide education and training to commercial marketing and sales teams on therapies and disease states. Required Qualifications: — Advanced clinical degree in life-science or basic-science discipline (MD, DO, PharmD, NP, PA, DNP, M.Sc, or Ph.D.) and industry experience as an MSL. — Significant clinical and/or industry experience in malignant hematology, HSCT, cellular therapy, CAR-T, immune effector cell therapies, or other advanced therapy modalities. — Strong understanding of cell therapy ecosystem including transplant center operations, apheresis and cell processing workflows, treatment center authorization, patient referral pathways, and competitive cell therapy products. — Strong understanding of clinical development, regulatory requirements, and commercial strategies; HEOR data experience is a plus. — Excellent interpersonal and communication skills to engage and influence diverse stakeholders. — Ability to interpret and present complex scientific data to diverse audiences. — Strong strategic thinking, problem-solving skills, and solution-oriented mindset. — Ability to collaborate with cross-functional colleagues to serve internal and external stakeholder needs. — Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment. Preferred Experience: — 5+ years of industry experience as an MSL. — Experience with field medical launch planning, execution, and post-launch support. — Direct experience supporting cell therapy, stem cell transplantation, CAR-T, or other advanced therapeutic platforms. — Experience working in a small biotech company or start-up environment. Compensation and Benefits: — Annual salary range $195,000 - $245,000 based on experience, education, location, and other factors. — Eligibility for pre-IPO equity and annual bonus. — Competitive medical, dental, and vision benefits. — PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. — Other perks include subsidized daily lunches and snacks at on-site locations.

Задачи: — Руководство коммерческой юридической функцией с основной ответственностью за поддержку первого запуска продукта в США. — Предоставление стратегических, практичных и своевременных юридических консультаций коммерческим подразделениям (продажи, маркетинг, доступ на рынок), медицинским и пациентским службам. — Являться экспертом по законодательству США в области здравоохранения, правилам FDA по промоушену и отраслевым кодексам для обеспечения законной и соответствующей деятельности до запуска, во время запуска и после. — Сотрудничество и возможное руководство отделом комплаенс для поддержания программы соответствия требованиям в США, основанной на оценке рисков и соответствующей корпоративным ценностям. — Поддержка межфункциональных команд через консультирование, обучение и разработку политик. Требования: — Значительный опыт стратегической коммерческой юридической поддержки в биотехнологической или фармацевтической индустрии, включая опыт работы с FDA в области промоушена, рекламы и доступа на рынок. — Способность сотрудничать с командами продаж, маркетинга, доступа на рынок, медицинских и пациентских служб для обеспечения соответствия деятельности требованиям. — Глубокие знания законодательства США в области здравоохранения, правил FDA по промоушену и отраслевых кодексов. — Опыт руководства или сотрудничества с отделом комплаенс для поддержания программы соответствия. — Умение предоставлять практичные, своевременные и бизнес-ориентированные юридические советы, работать как стратегический партнер. — Стратегическое мышление в сочетании с тактическим и операционным мастерством. — Способность работать в кросс-функциональной среде и влиять без формальной власти. Условия: — Возможность удаленной работы. — Ожидаемые командировки до 15% времени. Дополнительно: — Роль подчиняется старшему вице-президенту по юридическим вопросам. — Вакансия ориентирована на поддержку коммерческого запуска продукта в США.

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