Location: | Work Location: On-site | Contract Type: Full-Time | Job Category: Allied Health | Salary Range: $275,000 – $350,000
A dynamic, innovation-driven biotech company is seeking an experienced Medical Director to lead the medical strategy and oversight of oncology clinical trials from Phase I through Phase III. Reporting into senior leadership, this role will guide trial design, safety monitoring, regulatory documentation, and cross-functional coordination with internal and external stakeholders. This is a remote opportunity for a seasoned physician passionate about advancing precision cancer therapeutics.
Clinical Study Design & Development
Contribute to the creation and refinement of clinical protocols, amendments, reports, and study materials.
Partner with investigators and external experts to optimize study strategy.
Collaborate across biostatistics, data management, and clinical operations teams.
Medical Monitoring & Safety Oversight
Serve as the medical monitor for assigned trials.
Inform and adjust trial protocols based on evolving safety and efficacy data.
Develop medical input for trial monitoring plans and risk assessments.
Data Analysis & Interpretation
Lead review and interpretation of clinical data.
Support database lock activities, CSR authorship, and internal data reviews.
Engage with cross-functional teams on study metrics and safety outcomes.
Regulatory Affairs Support
Draft and review clinical components of regulatory documents including INDs, IBs, SAPs, and informed consent forms.
Ensure all documentation aligns with GCP/ICH and FDA regulatory standards.
Scientific Communication
Contribute to the development of publications, abstracts, and conference presentations.
Present key findings at internal reviews and external scientific forums.
Cross-functional and Vendor Leadership
Oversee third-party vendors related to clinical trial execution and medical monitoring.
Participate in advisory boards and investigator meetings.
Collaborate closely with internal stakeholders across functions to drive trial success.
Required
M.D. degree with 6+ years of clinical development experience in oncology.
Demonstrated background in solid tumor trials; breast cancer experience preferred.
Experience with Phase I–III oncology trials, with strong exposure to late-phase studies.
In-depth understanding of regulatory pathways and trial operations in the U.S.
Preferred
Knowledge of FDA submissions and IND processes.
Experience authoring or contributing to peer-reviewed publications.
Excellent cross-functional communication skills and attention to detail.
Comfort navigating remote work environments with global teams.
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