Senior Medical Director Clinical Development - Prostate Cancer
New
Based in the United StatesFull-TimeSenior
Salary$306,814 – $371,787 annually, plus potential bonus and equity opportunities
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Job Details
- Experience
- 10+ years
- Required Skills
- GCP
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.
Responsibilities
- 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.
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