Medical Director - III

Job Title:

Clinical Development Medical Director Location:

San Diego, CA Duration:

6 months Work Environment- Hybrid Job Summary The medical director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, and analysis. The medical director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups.

Job Responsibilities:

Study-level Clinical Development Leadership

• Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives.
• Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
• Lead peer-to-peer interactions with investigators.
• Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
• Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. Strategic Guidance, Clinical Insights & Interpretation
• Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
• Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.

Top 3

Skills:

• Protocol Development, Regulatory Document Development, and ability to research scientific literature, integrate data coming from internal program and interpret/make decisions or recommendations about how to proceed with all the data points. Job Qualifications
• Medical degree
• Healthcare background (PharmD, NP etc.) with relevant clinical or industry experience considered (typically 4+ years).
• 2-5 years industry experience
• Board certified/eligible in oncology or equivalent preferred