Director, Clinical Science

Job Title: Director, Clinical Science (Oncology/Neurology)

Summary: We seek a Director of Clinical Science to lead the design and interpretation of clinical studies. This role is vital for advancing investigational products from IND through registration, working in a cross-functional matrix environment.

Key Responsibilities:

• Guide clinical science planning and protocol development for clinical studies.
• Lead the creation and review of key study documents (e.g., protocols, reports, investigator brochures).
• Oversee study execution, collaborating with internal and external teams.
• Serve as a point of contact for study sites, addressing protocol-related questions.
• Review and ensure clinical data aligns with protocol and strategic objectives.
• Support regulatory submissions and interactions, including IND/NDA filings.
• Lead interactions with Key Opinion Leaders, advisory boards, and contribute to clinical publications.
• Act as a clinical representative on the product development team.

Qualifications:

• Advanced Degree (MS, PhD, MD, or PharmD).
• 7-10 years of clinical development experience in the pharmaceutical industry.
• Neurology and/or oncology focus preferred; medical imaging experience is a plus.
• Experience across all clinical development phases (I-IV) is desirable.
• Strong knowledge of regulatory guidelines and ICH/GCP.
• Proven ability to work in a multifunctional matrix environment.