Vice President, Legal, Technical Operations and R&D

Cambridge, MA; Seattle, WA; South San Francisco, CA
Feb 15, 2024
7104935002
Doctorate/PHD/MD
Full time

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 want to challenge status quo, and who lead with the desire to work on novel ideas.  As a Vice President, Legal Technical Operations and Research & Development, you will provide legal support for a breadth of complex US and global legal, transactional, regulatory and compliance matters in the area of drug manufacturing in support of advancing Sana’s cell and gene therapy products.  The position will also support Sana’s R&D functions and program teams by serving as a subject matter authority and by collaborating with other legal functions (e.g., regulatory, compliance, data protection/privacy, healthcare law, strategic transactions) on R&D matters as the company enters pivotal stage.      

What you’ll do

  • Act as the primary legal subject matter expert, reference and point-of-contact for the Technical Operations functions at Sana, including Manufacturing, Quality, Process Development, Supply Chain & CMC Portfolio, External Manufacturing, External Supply & Procurement, CMC Regulatory Affairs, Analytical Development & Operations and other Technical Operations teams.
  • Draft, review, negotiate, and manage the execution of a broad array of complex manufacturing and supply-chain related agreements (including CDMO, supply and service agreements, statements of work, material transfer agreements, quality agreements and related agreements) for the Technical Operations functions.
  • Advise management and internal Technical Operations clients on the company's rights and obligations under existing contracts, including agreements with existing suppliers, CDMOs and strategic partners.
  • Assist in the development and maintenance of standard contract forms, templates and playbooks.
  • Provide legal and regulatory guidance and interpretation on the scientific and technical requirements for CMC and Good Manufacturing Practice (GMP) related submissions to pending INDs, CTAs, BLAs and other life cycle management activities.
  • Review CMC and GMP related regulatory documents to assure compliance with regulatory standards and scientific/technical requirements and ensure their appropriateness for use and submission.
  • Advise on and support the development and expansion of quality management systems and processes and be a key stakeholder in driving the quality culture at Sana, including Good Clinical Practice (GCP_ and Good Laboratory Practice (GLP) compliance.
  • Work with Sana’s Chief IP Officer and other members of the Legal team to provide regulatory and compliance support on R&D related matters.
  • Perform other duties as assigned.

What we’re looking for

  • J.D. from a U.S. law school;
  • Current admission to any state bar in good standing (admission to Washington, California, or Massachusetts strongly preferred);
  • 10+ years of professional experience as an attorney;
  • Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP, quality assurance & management and related issues, preferably in the areas of cell and gene therapy;
  • Proven knowledge of CMC regulatory submission requirements for global filings (FDA and/or EMA, etc.)
  • Highly knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD);
  • Experienced contract negotiator; ability to understand and analyze legal contractual terms, accurately identify and assess the risks in a business arrangement, make decisions with respect to contract provisions that are aligned with Sana’s risk tolerance and contracting standards, and offer a practical, business-minded approach to contract negotiation;
  • Personable collaborator who can work successfully and build relationships with internal stakeholders and external parties to achieve business goals while managing risk;
  • Flexible and adaptable to shifting deadlines and priorities; able to effectively prioritize and manage a large volume of contracts and other assignments;
  • Analytical thinker with a track record of creatively synthesizing new solutions to old problems;
  • Strong organizational and administrative skills;
  • Strong attention to detail and excellent drafting skills; and
  • Effective and professional interpersonal and written communication skills.

What you should know 

  • The base pay range for this position at commencement of employment is expected to be between $350,000 and $400,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

How we work together

  • Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution 

Get to know us

At Sana, we believe that a diverse workforce 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 100% of the cost for employee health coverage and offer generous 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.