Vice President, Clinical Development (Precision Medicine)

TL;DR

Vice President, Clinical Development (Autoimmune): Driving product development across drugs, biologics, and cell/gene therapies with an accent on regulatory strategy and clinical trials for early to late phase. Focus on accelerating drug development timelines, FDA interactions, and integrated medical-clinical-regulatory strategies.

Location: Remote, United States

Salary: $254,900 - $382,300 USD

Company

Clinical research organization focused on precision medicine for autoimmune, rare, and orphan diseases.

What you will do

• Report to Chief Medical Officer and support medical strategy across the organization.
• Provide strategic drug development consulting integrating medical, clinical, regulatory, biostatistical, and translational insights for clients.
• Create, review, and revise protocols, case report forms, analysis plans, study designs, clinical trial reports, and IND applications.
• Review laboratory values, adverse events, data tables, and participate in feasibility discussions.
• Develop training modules, ensure high-quality data-driven deliverables, and propose strategies to accelerate timelines.
• Support business development through client engagement, proposals, and professional meetings globally.

Requirements

• MD, MBBS or equivalent plus fellowship training (Endocrinology, Rheumatology, Hematology-Oncology or related, board certification preferred)
• Experience in direct interactions with US and/or EU Regulatory Authorities
• At least 10 years senior leadership in clinical research industry with knowledge in operations, medical monitoring, biostatistics, regulatory, preclinical, and translational pharmacology.
• Clinical experience with authoring/reviewing protocols, statistical plans, IND, NDA, PSUR, DSUR, IB, ICF, and regulatory briefing documents.
• Working knowledge of global safety reporting processes.
• Ability to travel domestically/internationally for client/health authority meetings and conferences

Culture & Benefits

• Discretionary annual bonus.
• Health insurance, retirement savings, life insurance, disability benefits.
• Parental leave, paid time off for sick leave and vacation.