Exec. Dr. Clinical Operations

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As the Head of Clinical Operations, you will report to the Chief Medical Officer to provide strategic leadership for our clinical programs and cross functional activities.

This Executive Director role is a key member of the Development Team and interfaces with the Sana Executive Team.

• Manage all strategic and tactical operational aspects of assigned programs, including with external CROs
• Be a thought partner in defining our clinical development strategies, partnering closely with regulatory, medical, and CMC teams
• Drive smart, lean execution from scenario planning and forecasting to budget and resource allocation
• Perform tasks of Clinical Trial Manager and Clinical Trial Associate while recruiting and overseeing team members across projects in the Sana portfolio
• Build and lead a high-performing team of “scrappy,” mission-driven clinical operations professionals.
• Collaborate in the development of the target product profiles (TPPs) and compound development plans (CDPs) by generating scenario plans, high-level forecasting of timelines, assessing global program-level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies
• Develop and communicate budget, resources, risks and timelines to review committees
• Operate at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise. Long-range planning horizon is typically 2-5 years.
• Coaches and mentors Study Team Leaders and Clinical Trial Managers and appropriately delegates development opportunities, as needed
• May serve as a team lead on non-program/ functional initiative work streams
• Builds and maintains good relationships with internal and external key stakeholders. Contributes at Core Team level beyond operations and able to give input into Development strategy
• Leads and develops an environment supportive of innovation and smart risk-taking to drive and implement novel approaches to drug development
• Leads and supports staff through any organizational change and growth and provides input to senior management on potential organizational changes and improvements.
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

• Bachelors (preferably in a Life Science or Business discipline) or equivalent with 10+ years industry experience
• Study start-up experience – “scrappy” and willing to be hands on for the entire development team. Includes coverage for teammates when warranted
• Strong knowledge of regulatory requirements relative to GCPs, adverse event reporting, and knowledge of FDA regulations
• Proven track record showing excellent clinical project management skills, including clinical supply logistics and managing to approved budgets
• Detailed understanding of all aspects of clinical protocol design and implementation, and overall drug development
• Ability to effectively interface with medical personnel at clinical site(s) and lead multi‑disciplinary teams both internally & externally, proven experience in strategic planning
• Proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs and timelines for programs
• 2+ years of experience in clinical program management or a directly related role
• Significant drug development leadership experience, including history of effective management of cross-functional teams through phase 1-3 drug development and regulatory submissions (NDA/BLA/MAA).…