Executive Medical Director, Clinical Development, Breast Cancer
Accountabilities
The Executive Medical Director will provide scientific and strategic leadership for oncology clinical development programs, ensuring successful execution from early development through regulatory submission. This role will combine hands-on medical oversight, cross-functional collaboration, and strategic planning to accelerate the delivery of innovative therapies to patients.
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.
Provide mentorship and guidance to medical and scientific team members when applicable.
Support strategic growth initiatives and contribute scientific expertise to advance oncology development objectives.
Requirements
- An experienced oncology physician leader with deep expertise in clinical development, regulatory processes, and global pharmaceutical or biotechnology programs.
- Strong scientific credibility, strategic leadership capabilities, and the ability to operate effectively in a fast-paced, cross-functional environment.
- A 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.
- A 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.
- A 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.
- Ability to work independently, manage ambiguity, prioritize effectively, and deliver results in a dynamic environment.
Benefits
- Competitive base salary range of $300,000-$400,000 USD.
- Annual bonus eligibility and long-term incentive opportunities.
- Comprehensive healthcare coverage options.
- Company-sponsored retirement plan with employer matching contributions.
- Company-paid basic life and accidental death & dismemberment insurance.
- Flexible spending and health savings account programs.
- Remote work flexibility with a corporate position structure.
- Opportunity to contribute to innovative oncology programs with global patient impact.
- A collaborative environment focused on scientific excellence, inclusion, and professional growth.