Head of Pre-clinical Pharmacology and Toxicology
Company: Sana Biotechnology
Location: Cambridge
Posted on: July 10, 2025
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Job Description:
About the role 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 Pre-clinical pharmacology and toxicology you will
report to the Chief Scientific Officer to design, execute, and
interpret nonclinical studies conducted in the appropriate 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 10
years industry experience in a field related to industrial
pharmacology /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, autoimmune disease and diabetes, 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
programs 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. A D.V.M. is highly desirable but not mandatory. 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. The base pay range for this position at commencement of
employment is expected to be between $275,000 - $350,000 annually;
however, base pay offered may vary depending on multiple
individualized factors, including market location, job-related
knowledge, skills, and experience How we work together for patients
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.
Keywords: Sana Biotechnology, Brookline , Head of Pre-clinical Pharmacology and Toxicology, Science, Research & Development , Cambridge, Massachusetts