Sana Biotechnology, Inc. · 16 hours ago
Executive Director, Head of Clinical Operations
Sana Biotechnology is a growing company focused on engineered cells as medicines, seeking an Executive Director, Head of Clinical Operations to provide strategic leadership for clinical programs. The role involves managing operational aspects of clinical programs, collaborating with cross-functional teams, and building a high-performing team of clinical operations professionals.
BiotechnologyHealth CareLife ScienceProduct Research
Responsibilities
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
Qualification
Required
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). Lifecycle experience preferred
Proven ability to lead and influence data-driven strategic planning and implementation, including the ability to focus a team to work towards its goals effectively, efficiently and on target
Desire to shape a Clinical Operations organization for future success
Ability to travel as required
Preferred
Experience leading small teams that can grow over time
High degree of accountability
Willingness to participate in day-to-day, hands-on tasks while team is being built and beyond
Strong skills in: communication, both oral and written; presentation and meeting leadership; coaching and personnel development
Ability to deliver and present clear messages to teams, various functional areas, and senior leaders
Demonstrates excellent communication (written and verbal), presentation and interpersonal skills
Displays ability to lead and innovate successfully within a change management culture and fast-paced environment
Successfully manages conflict and fosters open communication with others
The ideal candidate will have experience with cell therapy and diabetes or endocrine product development
Knowledge of industry trends, tools and partners that will help us stay ahead
Benefits
Health coverage
Paid time off benefits, such as holidays, vacation, sick time, and parental leave
Short- and long-term disability
Employer paid basic life insurance
Additional voluntary life insurance protection
Financial wellness programs including financial planning resources
401(k) Plan with an immediately vested employer match
Tuition Reimbursement and Student Loan Repayment
Employee Stock Purchase Plan
Commuter subsidy
Variety of wellness offerings
Company
Sana Biotechnology, Inc.
Sana Biotechnology is focused on utilizing engineered cells as medicines for patients.
H1B Sponsorship
Sana Biotechnology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (15)
2023 (8)
2022 (24)
2021 (8)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
$951.3M2025-08-06Post Ipo Equity· $86.3M
2024-02-07Post Ipo Equity· $165M
2021-02-04IPO
Leadership Team
Recent News
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