Senior Director, Clinical Development

Job 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.
• Lead 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.

Basic Qualifications

• MD/DO with 6+ years of clinical, scientific and/or drug development experience, including substantial experience in biopharmaceutical clinical development.
• 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%.