Head of Toxicology and Biodistribution

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 the Head of Toxicology and Biodistribution you will report the interim Head of Translational Sciences to design, execute, and interpret nonclinical safety studies conducted in the appropriate toxicological species.  As the functional leader you will lead the team using science-based PK/PD and toxicology plans to support clinical development at this critical junction in the company.  Cool stuff.

What you’ll do

• Develop toxicology strategies and provide expert support to research and development projects in conjunction with program teams
• Collaborate on the design of non-GLP investigative and pharmacology studies to support developmental cell and gene therapies, as needed
• Directly interface with contract research organizations (CROs) to drive operational, budgetary, and compliance activities as needed
• Partner and network with nationally and internationally recognized leaders/consultants in Toxicology and Drug Safety
• Plan, coordinate, execute, and oversee the conduct of external GLP and non-GLP toxicology studies to support development programs
• Review, summarize and integrate complex data sets across multiple disciplines
• Manage the preparation and presentation of nonclinical safety data for project teams, portfolio management presentations, and internal /external partners and scientific groups
• Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of results on program and clinical/regulatory strategy
• Finalize toxicology reports and all sub-vendor reports, manage the tabular presentation of data in accordance with CTD format and have a familiarity with SEND requirements
• Support the preparation of national and international regulatory submissions and interactions with governments, and effectively communicate with regulatory bodies in the process of product support such as INDs / NCOs, IBs, and NDAs
• Manage and prepare toxicological risk assessments to support drug development and manufacturing
• Work closely with the Clinical team to support and defend the clinical trial design plans in a data-driven manner
• Interact cross-functionally with Research, Regulatory, CMC, and Assay Development teams
• Maintain a current understanding of pharmacology, pharmacokinetic and Toxicology literature and methodology, as well as for scientific literature related to the disease biology, therapeutic areas, and personalized and gene therapy products
• Maintain a current understanding of regulatory requirements and guidance
• 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

What we’re looking for

• A Ph.D., postdoctoral training and at least 15 years industry experience in a field related to industrial Toxicology in a scientific discipline that encompasses the basic biologic sciences, including molecular biology, histology and pathology and PK/PD
• Proficient in cell therapy product development. Previous experience in areas of oncology, type 1 diabetes, or CNS disease with an understanding of corresponding animal models of disease and associated translational aspects of drug development is desirable
• Experience in designing, monitoring, interpreting and effectively communicating nonclinical safety studies
• Experience in developing pharmacology/toxicology program to support early and later stage drug development and in preparing regulatory filings such as INDs/CTAs/NDAs/MAAs
• Previous experience and excellence in managing people, both directly and cross-functionally, and creating teams to support nonclinical programs
• Strong understanding of compliance guidance documents including GLP regulations
• Must be able to critically evaluate written and published pharmacology/toxicology documents for overall quality and acceptability of scientific interpretations

What will separate you from the crowd   

• Excellent verbal and written communication
• Problem solving and organizational skills with attention to detail. Strong team player and strong motivational skills

What you should know

• Required ability to travel to Sana locations as well as site visits to oversee conduct of and necropsy of animals in a study
• Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19
• The base pay range for this position at commencement of employment is expected to be between $300,000 and $350,000/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.