Senior Director, Clinical Development

Key Responsibilities:
- Lead and execute the clinical development strategy for novel oncology therapies.
- Collaborate with internal and external stakeholders to design and implement clinical development plans across indications.
- Author/lead key clinical trial documents and clinical sections of regulatory filings (e.g., pre-INDs and INDs).
- Serve as primary Medical Monitor for assigned programs, overseeing internal/external teams and providing medical guidance to CRO partners and clinical sites.
- Support safety monitoring and pharmacovigilance activities.
- Collaborate cross-functionally (clinical operations, regulatory, project management, manufacturing, business development) to define timelines, manage risks, and ensure milestone delivery.
- Integrate biomarker and pharmacodynamic endpoints into clinical study designs with translational sciences.
- Establish and maintain relationships with PIs, KOLs, and other external stakeholders.
- Review, assess, interpret, and communicate clinical trial data to internal stakeholders and external partners.
- Lead clinical trial data publication efforts.
- Facilitate key meetings (advisory boards, safety review committees, investigator meetings).

Qualifications:
- M.D., D.O., or equivalent; board certification in medical oncology or hematology preferred.
- 2–4+ years of experience leading clinical development and Phase 1–3 oncology clinical trials in a biotech/pharma setting.

Knowledge and Skills (required/preferred):
- Experience advancing programs from IND-enabling studies through early and late-stage clinical development.
- Understanding of FDA and EMA regulatory requirements with a successful regulatory interaction track record.
- Demonstrated leadership and ability to manage cross-functional teams.