Leads the direction, planning, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- Own the design and implementation of multiple clinical development programs (or one large complex program) aligned to the product development plan, including compliance and regulatory requirements.
- May lead clinical study teams; monitor study integrity; review/interpret/communicate safety and efficacy data; ensure enrollment and timelines for key deliverables with Clinical Operations.
- Own design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists on related programs.
- May serve on/co-chair Integrated Evidence Strategy Team(s) to develop a cross-functionally aligned Clinical Development Plan with contingencies/alternatives (including matrix supervision as CST Co Chair).
- Serve as in-house clinical expert for molecules/diseases; coordinate scientific/medical activities; may support due diligence/business development and translational strategies.
- Act as clinical lead to solicit opinion leader interactions; partner with Medical Affairs and Commercial to incorporate perspectives into plans/protocols.
- Stay current via literature/conferences; may represent the company at external meetings.
- Understand and comply with regulatory requirements; serve as clinical representative for key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance, SOPs, and quality standards.
Qualifications:
- Bachelorβs in sciences; MS/PhD preferred. Hematology preferred; Non-Hodgkin Lymphoma experience strongly preferred.
- 8+ years clinical trial experience in pharma/academia/equivalent.
- Ability to run complex clinical research programs independently.
- Proven leadership; lead through influence on cross-functional global teams.
- Strong clinical trial methodology, regulatory/compliance knowledge; experience designing study protocols and clinical strategy.
- Excellent oral/written English communication.
- Judgment to solve complex problems.
Benefits (as stated): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees). Short-term incentive eligibility noted.