| Location | Cambridge, Massachusetts |
About the role:
A stealth mode biotech company is seeking a highly motivated Director / Senior Director to lead
toxicology activities supporting the development of novel therapeutics. The successful candidate
will play a key role in developing and executing the nonclinical toxicology strategy, including
non-GLP NHP studies, GLP toxicology studies, and IND-enabling activities. This individual will
work closely with internal teams and external CROs to design, execute, interpret, and report
toxicology studies and will contribute to preparation of regulatory submissions. The position is a
rare opportunity to play a pivotal role in the successful development of new drugs for patients
within an early-stage therapeutics company backed by highly regarded investors.
Key Responsibilities:
Lead development and execution of nonclinical toxicology strategies supporting
candidate selection, GLP toxicology, IND-enabling activities, and first-in-human studies
Design and oversee non-GLP and GLP toxicology studies, including dose range-finding,
repeat-dose, recovery, and other studies as appropriate for the development program
Partner with internal teams and external CROs to develop study designs, protocols,
dosing strategies, endpoints, timelines, and data analysis plans
Serve as the primary scientific point of contact for external toxicology CROs, overseeing
study design, study execution, data review, issue resolution, and delivery of high-quality
study reports
Interpret toxicology, clinical pathology, histopathology, and other nonclinical data to
identify potential target organ toxicities, exposure-response relationships, safety
margins, and other development risks
Integrate toxicology findings with pharmacology, PK/PD, bioanalytical, CMC, and clinical
development data to inform candidate selection, human dose selection, and overall
development strategy
Support preparation and review of IND-enabling documentation, including nonclinical
study reports, investigator materials, regulatory briefing documents, and IND
submissions
Collaborate with regulatory and clinical teams to develop nonclinical sections of
regulatory submissions and support interactions with regulatory agencies
Establish and maintain appropriate toxicology plans, timelines, budgets, and key
milestones across development programs
Maintain detailed records, perform data analysis, and clearly communicate toxicology
findings and recommendations to cross-functional teams and company leadership
Ensure toxicology activities are conducted in accordance with applicable GLP, animal
welfare, quality, and regulatory standards
The person in this role will collaborate closely with scientists and operators in a fast-
paced biotech startup environment and will be expected to operate effectively with a high
degree of autonomy
Qualifications:
PhD, DVM, or equivalent advanced degree in Toxicology, Pharmacology, Veterinary
Medicine, or a related field with 10+ years of relevant industry experience preferred
Experience leading GLP toxicology and IND-enabling programs
Experience developing a toxicology strategy for a biologics program, including antibody
or antibody-conjugate, from Discovery to First-In-Human
Strong understanding of nonclinical drug development for biologic therapeutics, including
toxicology study design, safety assessment, exposure margins, and interpretation of
toxicology findings
Experience managing external toxicology CROs, including small and large animal study
design, site selection, protocol development, execution, data review, and final reports
Experience supporting IND submissions and regulatory interactions with the FDA and
other agencies; experience with international submissions is a plus
Strong written and verbal communication skills, with the ability to synthesize complex
nonclinical data and communicate clear conclusions and recommendations
Experience working in a small, fast-paced biotechnology environment and managing
multiple priorities preferred
What we offer:
Competitive compensation and benefits
A collaborative, small-team environment with growth opportunities
The opportunity to contribute to innovative drug development efforts and join an early-
stage biotechnology company backed by highly regarded investors
Location: Cambridge, MA (Hybrid)