Senior Director, Clinical Development
About The Position
The Senior Medical Director provides strategic and scientific leadership for one or more development programs and serves as the clinical development lead from early development through registration planning, as applicable. The role is responsible for shaping clinical development strategy, overseeing execution across multiple studies, and partnering with cross-functional teams to advance programs in alignment with corporate objectives. The Senior Medical Director is expected to influence development decisions, represent clinical development to senior leadership and external stakeholders, and contribute to portfolio and lifecycle planning. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Requirements
- MD/DO with 6+ years of clinical, scientific and/or drug development experience, including substantial experience in biopharmaceutical clinical development
Nice To Haves
- Board certification in Hematology/Oncology or a related specialty.
- Significant experience leading oncology drug development programs with responsibility for clinical strategy and execution.
- Demonstrated experience leading first-in-human, proof-of-concept, and registrational development programs.
- Cell therapy experience preferred, including autologous, allogeneic, and/or in vivo cellular therapy platforms.
- Experience leading interactions with global health authorities and supporting major regulatory submissions.
- Demonstrated ability to influence cross-functional teams and drive decision-making in a matrix environment.
- Proven track record of scientific leadership through publications, presentations, advisory boards, and engagement with external experts and key opinion leaders.
- Experience mentoring and developing physicians, scientists, and cross-functional team members.
- Strong strategic thinking with the ability to balance scientific rigor, operational feasibility, regulatory requirements, and business objectives.
- Experience evaluating external innovation, licensing opportunities, partnerships, or business development transactions preferred.
- Demonstrated ability to thrive in a dynamic and evolving environment, effectively managing competing priorities with minimal direction.
- Willingness to travel up to 25%.
Responsibilities
- Lead the clinical development strategy for one or more oncology programs, providing scientific and medical leadership from IND-enabling activities through proof-of-concept and early development milestones.
- Provide clinical oversight and medical monitoring across one or more clinical studies, ensuring participant safety, data integrity, and high-quality execution.
- Lead cross-functional teams in the design, implementation, and execution of clinical development plans and clinical studies.
- Author and review protocols, investigator brochures, clinical study reports, regulatory documents, and other key clinical development deliverables.
- Provide strategic leadership for regulatory interactions and submissions, including INDs, health authority meetings, regulatory responses, as applicable.
- Collaborate with Research, Translational Sciences, Clinical Operations, Safety, Regulatory Affairs, and CMC teams to advance development programs and achieve key milestones.
- Build and maintain relationships with investigators, key opinion leaders, scientific advisors, and other external stakeholders.
- Present clinical data and development strategies to governance committees, health authorities, scientific conferences, and investigator meetings; lead or contribute to scientific publications and presentations.
- Mentor junior physicians and contribute to portfolio strategy, business development evaluations, and external innovation assessments, as applicable.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
