Senior Director, Clinical Program Management
New
United StatesFull-TimeDirector
Salary240,000 - 270,000 USD per year
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Job Details
- Experience
- 15+ yrs
- Required Skills
- Project ManagementRisk ManagementStakeholder management
Requirements
- BA/BS degree required; advanced degree (Ph.D., MS, MD) and/or PM Certification preferred.
- 15+ years in a Program/Project management supporting drug development.
- Experience with gene or cell therapy development programs.
- Extensive experience managing and partnering with CDMOs in the Cell and Gene Therapy space.
- Experience working on the sponsor side in Cell and Gene Therapy organizations.
- Experience applying principles, concepts, practices, and standards of project management for drug development.
- Ability to understand and communicate scientific and business elements associated with engineered T cell therapies.
- Proven track record for delivering projects on time and in full.
- Strong skills in management of external stakeholders and ability to influence.
- Excellent interpersonal, conflict management, and communication skills.
Responsibilities
- Lead cross-functional program management activities supporting autoimmune clinical development programs.
- Develop and maintain integrated clinical development plans, timelines, milestones, budgets, and risk management strategies across multiple functional areas.
- Drive execution and alignment across Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs, Manufacturing, and Quality.
- Partner with Clinical and Medical leadership to support development strategy, indication prioritization, and lifecycle planning for assigned programs.
- Ensure program activities support regulatory milestones including INDs, protocol amendments, global health authority interactions, and potential BLA/MAA submissions.
- Partner with Clinical Operations to proactively identify enrollment, operational, and site-performance risks and implement mitigation strategies.
- Ensure seamless coordination between clinical and CMC activities supporting cell therapy manufacturing, supply planning, patient scheduling, and treatment logistics.
- Facilitate governance meetings, cross-functional team meetings, and executive program reviews.
- Collaborate with Clinical Research Scientists and Medical Directors on protocol strategy, clinical endpoints, efficacy measures, biomarkers, and patient-reported outcomes relevant to autoimmune studies.
- Support budget forecasting, scenario planning, and resource prioritization across clinical programs.
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