Director, Clinical Science
Director, Clinical Science
The Elle Group
Greater Boston
See who The Elle Group has hired for this role
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.
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Seniority level
Director -
Employment type
Full-time -
Job function
Science, Research, and Other -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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