Role Summary
Sana Biotechnology is growing and hiring new team members who believe in the potential of engineered cells as medicines. We are seeking a highly motivated and hands-on Senior Director of Clinical Development – Type 1 Diabetes to lead clinical strategy and execution for our cell therapy program. This role is ideal for a physician-scientist who thrives in a fast-paced, collaborative environment and is passionate about transforming care for patients with autoimmune diabetes. You’ll report to the Chief Medical Officer.
Responsibilities
- Clinical Strategy & Execution
- Lead the design, implementation, and oversight of clinical trials for cell therapy in Type 1 Diabetes.
- Develop and refine clinical development plans in alignment with regulatory, scientific, and commercial objectives.
- Contribute to regulatory submissions, including IND, protocol amendments and BLA, as well as author and review clinical sections.
- Study Oversight & Site Engagement
- Serve as medical monitor for clinical trials, ensuring patient safety and data integrity.
- Build strong relationships with clinical trial sites, investigators, and study coordinators to ensure high-quality execution.
- Collaborate with internal functional groups, as well as the clinical research organization and other vendors to proactively identify and resolve study-related issues.
- Cross-Functional Collaboration
- Work closely with Regulatory Affairs, Translational Medicine, CMC, Quality Assurance, Pharmacovigilance, and Program Management, among others, to ensure seamless integration of clinical insights across the development lifecycle.
- Partner with external advisors and KOLs to shape program strategy and ensure scientific rigor.
- Innovation & Agility
- Apply creative thinking and learning agility to solve complex clinical and operational challenges.
- Stay abreast of emerging science, competitive landscape, and regulatory trends in diabetes and cell therapy.
- Leadership & Influence
- Mentor junior clinical team members and contribute to a culture of excellence, integrity, and innovation.
- Represent the company at scientific and medical conferences, advisory boards, and regulatory meetings.
Qualifications
- Required: MD, MD/PhD, or MD with another advanced degree (e.g., MPH) with board certification in Endocrinology or Immunology; either adult or pediatric training.
- Required: Clinical and/or Clinical Research experience working with patients with Type 1 Diabetes.
- Required: 5+ years of industry experience in clinical development, ideally in metabolic and/or autoimmune diseases, with experience working on Type 1 diabetes drug development being a plus.
- Required: Demonstrated experience in early- to mid-stage clinical trials, preferably including cell and/or gene therapy.
- Required: Strong strategic and tactical thinking, with a track record of driving programs forward.
- Required: Excellent communication and interpersonal skills; collaborative and humble leadership style.
- Required: Willingness to be hands-on and detail-oriented while maintaining a big picture perspective.
Additional Requirements
- Experience working with patients with Type 1 Diabetes.
- Familiarity with regulatory pathways for advanced therapies (e.g., Fast Track, RMAT).
- Passion for innovation and improving patient outcomes through transformative science.