This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Medical Director Clinical Development – Prostate Cancer based in the United States.
This is a senior clinical leadership role focused on advancing innovative oncology therapeutics for patients with prostate cancer. The position plays a critical role in shaping and executing global clinical development strategies across the full lifecycle of drug development, from early IND planning through late-stage, registrational trials. You will provide medical and scientific leadership for cross-functional teams, working closely with research, translational medicine, regulatory, and commercial stakeholders. The role involves close collaboration with clinical investigators and thought leaders to design impactful clinical programs that meet both patient needs and regulatory expectations. It is ideal for an experienced oncology drug developer who thrives in a fast-paced, science-driven biotech environment and is passionate about transforming cancer care.
Accountabilities:
- Lead the design and execution of global clinical development strategies for prostate cancer assets across all stages of development (IND through Phase 3).
- Collaborate with clinical investigators, key opinion leaders, and internal teams to develop and refine clinical trial designs and development plans.
- Oversee cross-functional clinical study teams responsible for study design, implementation, monitoring, analysis, and reporting.
- Contribute to protocol development, investigator brochures, clinical study reports, and other regulatory and clinical documentation.
- Lead interactions with regulatory authorities, including preparation of briefing materials and participation in health authority meetings.
- Support IND submissions, regulatory filings, and clinical development strategy for oncology programs.
- Guide medical monitoring activities and oversee data review and independent data monitoring committees.
- Build, mentor, and lead a high-performing clinical development team focused on prostate cancer programs.
- Collaborate with research, translational, and business development teams to inform pipeline strategy and combination opportunities.
- Ensure adherence to GCP, ICH guidelines, and ethical standards across all clinical trials.
Requirements:
- MD or equivalent medical degree with specialization in oncology preferred.
- 10+ years of experience in pharmaceutical, biotech, or academic clinical development focused on oncology solid tumors.
- Demonstrated drug development experience specifically in prostate cancer.
- Strong track record of leading global clinical trials across Phase 1–3 development programs.
- Experience in regulatory interactions, including IND, NDA/MAA submissions and health authority engagements.
- Deep understanding of clinical trial operations, protocol design, study execution, and data analysis.
- Proven leadership experience managing cross-functional clinical teams in a biotech or pharmaceutical environment.
- Strong knowledge of GCP, ICH guidelines, and global clinical development standards.
- Excellent strategic thinking, communication, and stakeholder management skills.
- Ability to thrive in a fast-paced, high-accountability environment with multiple priorities.
- Preferred: experience in radiopharmaceuticals or emerging oncology modalities.
Benefits:
- Competitive compensation: $306,814 – $371,787 annually, plus potential bonus and equity opportunities
- Comprehensive medical, dental, and vision insurance coverage
- Retirement savings plan (401(k)) with employer support
- Paid time off, flexible vacation policies, and holiday benefits
- Wellness and employee assistance programs supporting mental and physical health
- Life, disability, accident, and supplemental insurance coverage
- Professional development opportunities in a leading oncology research environment
- Exposure to cutting-edge radiopharmaceutical and prostate cancer therapeutic development
- Inclusive, mission-driven environment focused on transforming patient outcomes