Provide medical oversight and clinical leadership for ongoing clinical development studies in regenerative medicine, with a focus on participant safety, data integrity, and study execution. The work includes reviewing protocols and study documents, interpreting clinical and safety data, and supporting regulatory interactions across the development program. This role is highly cross-functional and involves close collaboration with clinical operations, regulatory, pharmacovigilance, biostatistics, and medical affairs.
Key Responsibilities
- Provide medical oversight across clinical development programs.
- Act as Medical Monitor for clinical studies and review safety signals.
- Contribute to the design, development, and review of clinical protocols and study documents.
- Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics, and Medical Affairs.
- Support regulatory submissions and interactions with health authorities.
- Review and interpret clinical and safety data to inform development decisions.
- Assist with investigator meetings, safety review committees, and other study activities.
- Ensure studies follow ICH-GCP, regulatory requirements, and company SOPs.
Required
- MD (Doctor of Medicine) degree.
- Significant clinical development experience in the pharmaceutical or biotechnology industry.
- Experience in one or more of the following areas: vascular, cardiovascular, renal, nephrology, or regenerative medicine.
- Prior experience as a Medical Monitor or providing medical oversight for clinical trials.
- Strong understanding of clinical trial design, protocol development, safety review, and regulatory requirements.
- Excellent communication and cross-functional collaboration skills.
Preferred
- Experience working in a small biotech or start-up environment.
Benefits & Perks
- Contract role with approximately 30-40 hours per week.
- Remote work within the US.
- Potential transition to a permanent position.