Medical Director/Sr. Medical Director, Clinical Development
J
JobgetherBiotechnology
Based in United StatesFull-TimeSenior
Salary$330,000 - $370,000 USD
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Job Details
- Experience
- 5+ years of clinical research experience, including at least 3 years within the biopharmaceutical industry
- Required Skills
- GCP
Requirements
- MD, DO, MD-PhD, or equivalent international medical degree.
- 5+ years of clinical research experience.
- At least 3 years within the biopharmaceutical industry supporting clinical development programs.
- Experience designing and executing late-phase clinical trials.
- Strong understanding of GCP/ICH guidelines, clinical trial methodologies, regulatory requirements, and drug development processes.
- Demonstrated ability to interpret, analyze, and present complex clinical safety and efficacy data.
- Experience contributing to regulatory submissions and clinical development documentation.
- Strong scientific communication skills.
- Ability to work effectively in cross-functional teams and manage multiple priorities.
Responsibilities
- Serve as the physician lead for clinical trials involving advanced cell therapy programs in autoimmune disease indications.
- Provide medical oversight for clinical studies, including collaboration with investigators, clinical sites, and external medical monitoring partners.
- Lead the design, execution, and interpretation of clinical trials across assigned development programs.
- Partner with clinical operations, biometrics, regulatory, commercial, and other internal teams to ensure alignment on clinical strategy and execution.
- Provide scientific and medical input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
- Review, analyze, and interpret clinical safety, efficacy, pharmacokinetic, and biomarker data to inform development decisions.
- Develop and contribute to key clinical documents, including protocols, informed consent forms, clinical development plans, and scientific publications.
- Lead preparation of clinical sections for regulatory documents, including investigator brochures, safety updates, clinical study reports, and responses to health authorities.
- Build and maintain relationships with external investigators, researchers, scientific advisors, CROs, and strategic partners.
- Identify opportunities and support investigator-sponsored studies and research collaborations to advance scientific understanding.
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