Our client, a clinical-stage biotechnology company is seeking an experienced Contract Medical Director to provide senior-level medical and clinical development leadership for a novel endocrine therapy program in breast cancer, including neoadjuvant and metastatic disease settings.
This is a high-impact consulting role focused on clinical development strategy, regulatory pathway planning, safety oversight, translational integration, and partnering support. The Medical Director will work closely with executive leadership to shape development plans, interpret emerging science, and support efficient execution in a lean biotech environment.
Key Responsibilities:
Clinical Development & Regulatory Strategy
- Develop and refine the clinical development strategy for an endocrine therapy program in breast cancer
- Define requirements for potential marketing applications across major regulatory regions (e.g., U.S., Europe, Japan)
- Contribute to target product profiles (TPPs), indication prioritization, and lifecycle planning
Executive & Partnering Support
- Serve as a senior medical advisor to executive leadership
- Support business development and partnering discussions, including scientific positioning of combination strategies
- Participate in external scientific and strategic discussions with potential collaborators or partners
Safety Oversight & Medical Governance
- Serve as medical safety back-up for ongoing clinical trials, supporting the acting CMO
- Review and interpret safety data, AEs/SAEs, and emerging risk signals
- Support Safety Review Committees and internal safety governance as needed
Translational & Scientific Integration
- Evaluate and integrate new external scientific findings with internal clinical and translational data
- Identify opportunities to translate mechanistic insights into new treatment approaches, combinations, or differentiated development paths
- Partner with internal and external experts to align science, clinical strategy, and execution
Broader Medical & Clinical Leadership
- Provide medical input into protocol development, study design, endpoints, and execution strategy
- Support overall breast cancer and endocrine therapy strategy as programs evolve
- Act as a flexible senior medical resource across the portfolio as needed
Ideal Consultant Profile
- MD with strong experience in breast cancer drug development
- Background in endocrine therapy, hormone-driven oncology, or related areas
- Experience supporting neoadjuvant and/or metastatic breast cancer programs
- Familiarity with regulatory strategy and marketing application planning (FDA/EMA/PMDA exposure preferred)
- Comfortable operating as a fractional senior medical leader in a small, fast-moving biotech
- Experience supporting combination strategies and external partnerships preferred
- Strategic, collaborative, and hands-on mindset
Why This Role Is Compelling
- Opportunity to shape clinical and regulatory strategy for a differentiated breast cancer therapy
- High visibility with executive leadership
- Ability to influence development, translational science, and partnering simultaneously
- Flexible consulting structure suited for experienced physician-leaders