Executive Medical Director, Clinical Development, Breast Cancer
New
Based in United StatesFull-TimeExecutive
SalaryCompetitive base salary range of $300,000–$400,000 USD
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Job Details
- Experience
- 12+ years
- Required Skills
- GCP
Requirements
- Medical degree (MD or equivalent) with 12+ years of pharmaceutical or biotechnology industry experience.
- Board certification in oncology and/or specialized oncology training strongly preferred.
- Specific experience in breast cancer clinical development or oncology compound development strongly preferred.
- Proven experience leading Phase I–IV oncology clinical development programs resulting in successful regulatory submissions.
- Strong understanding of clinical trial methodology, statistical principles, medical monitoring, and clinical data interpretation.
- Experience authoring or contributing to clinical trial publications and scientific communications.
- Strong knowledge of GCP, ICH guidelines, FDA, EMA, and global regulatory requirements.
- Demonstrated ability to develop clinical strategies and translate scientific insights into actionable development plans.
- Experience collaborating with clinical operations, regulatory, statistics, PK/PD, medical affairs, commercial, and other development functions.
- Proven ability to interact effectively with investigators, key opinion leaders, regulatory authorities, and external advisors.
- Excellent written and verbal communication skills with the ability to influence stakeholders at all levels.
- Strong leadership capabilities with experience guiding multidisciplinary teams.
Responsibilities
- Represent the clinical function on global development teams and contribute to clinical development strategies, plans, and execution for assigned oncology assets.
- Lead the development of clinical study protocols, amendments, study guides, training materials, and other essential clinical documentation.
- Provide medical monitoring oversight, including safety data review, identification of potential signals, and support for clinical site inquiries.
- Partner with clinical operations teams to optimize study execution, patient enrollment strategies, site engagement, and overall trial quality.
- Interpret clinical data and provide medical leadership for study reports, regulatory briefing documents, submission packages, and scientific communications.
- Ensure consistency, accuracy, and scientific rigor across clinical development materials and regulatory interactions.
- Develop innovative clinical strategies to optimize development timelines while adapting to evolving regulatory requirements.
- Act as the clinical lead for assigned programs and build strong relationships with investigators, key opinion leaders, scientific advisors, and regulatory stakeholders.
- Collaborate with multidisciplinary teams including regulatory affairs, statistics, pharmacology, medical affairs, commercial, and health economics functions.
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