About the role
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. We are seeking an accomplished and strategic Senior Director, Clinical Regulatory Affairs to shape global clinical regulatory strategy across our pipeline, with a particular focus on programs in Type 1 diabetes, oncology, and autoimmune disease. This role is ideal for a seasoned regulatory leader who is excited by science‑driven development, cross‑functional collaboration, and advancing therapies for serious diseases.
You will develop and execute comprehensive regulatory strategies for clinical‑stage programs, guide teams on global regulatory requirements, and help shape the long‑term regulatory vision for the portfolio from Phase 1 to commercialization. Clinical-stage regulatory experience in our therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies is preferred. Experience in regulatory operations and/or ex-US submission planning are also considered beneficial for the role. This position reports to the Vice President, Head of Regulatory Affairs and would work out of Sana’s offices in Cambridge (preferred), South San Francisco, or Seattle.
What you’ll do
What we’re looking for
What will separate you from the crowd
What you should know
How we work together for patients
Get to know us
At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample time-off (various 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, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.