Senior Medical Director, Clinical Development

The role

This person will provide strategic leadership for clinical development strategy, planning, and tactical implementation. They will serve as the Clinical Development leader for a clinical stage program and design the clinical development plan.

What you will do

• Lead program strategy in a matrixed environment with clinical operations, regulatory, clinical pharmacology, research, and CMC.
• Lead the design and implementation of clinical development plans to achieve target product profiles.
• Guide development teams with creative and realistic approaches to drug development.
• Direct and design fit-for-purpose clinical trials across all phases.
• Design and draft protocol synopses, clinical trial protocols, amendments, and supporting documents.
• Contribute to IBs, regulatory documents, CSRs, and publications.
• Provide medical oversight of multiple clinical studies and guidance on safety monitoring issues.
• Collaborate with regulatory affairs to develop strategic regulatory strategies.
• Communicate significant issues to the CDP or emerging safety risks to management.
• Mentor and develop junior physicians and clinical development staff.

Required qualifications

• MD or MD/PhD
• 5+ years of experience in Clinical Development or related pharmaceutical capacity
• Endocrinology/Board Certified Endocrinologist or extensive experience in endocrinology-related drug-development
• In depth knowledge of drug development process and oversight of clinical trials
• Experience in first-in-human trials and late phase development and product filing/ registration
• Experience managing significant accelerations and challenges in clinical programs
• Evidence of successful enterprise/matrix leadership
• Expertise in innovative clinical trial design, scientific writing, and implementation of clinical protocols and CSRs
• Experience in all phases of regulatory submissions and interactions
• International experience
• Negotiation experience with the FDA
• Knowledge of GCP, ICH, ICJME Guidelines, FDA and other international regulatory body requirements

Nice to have

• Rare disease experience

Benefits

• Stock options
• Annual target bonus

About the company

Septerna is a biotechnology company based in South San Francisco, CA. The company uses a Native Complex Platform™ to develop GPCR-targeted small molecule programs.