Job Title: Principal Scientist, Toxicology
Location: Cambridge, MA
Department: Preclinical Safety Assessment
Reports To: Executive Director, Preclinical Development
About Pinetree Therapeutics
Pinetree Therapeutics is an innovative biotechnology company focused on developing transformative therapies for patients with serious diseases. We are committed to scientific excellence, cross-functional collaboration, and advancing a robust pipeline of biologics from discovery through clinical development.
Position Summary
We are seeking a Principal Scientist, Toxicology to lead nonclinical safety evaluation activities supporting drug discovery and development across multiple therapeutic areas. This role is critical to the success of our pipeline and involves designing and overseeing toxicology strategies, studies, and regulatory submissions for large molecule programs and other modalities.
You will serve as the Nonclinical Safety Project Team Representative, collaborating with discovery, translational, regulatory, and clinical development colleagues to support informed decision-making and ensure patient safety.
Key Responsibilities
- Serve as the toxicology subject matter expert on cross-functional project teams.
- Design and oversee nonclinical safety assessment strategies for bispecific antibodies and other modalities.
- Lead the planning, conduct, monitoring, and interpretation of GLP and non-GLP in vivo and in vitro toxicology and safety pharmacology studies.
- Evaluate, interpret, and integrate toxicology, pharmacokinetic, and pathology data to support program progression.
- PK, PK/PD, and or modeling experience/familiarity a plus
- Develop and review relevant sections of regulatory submissions (IND, CTA, BLA, NDA, etc.).
- Collaborate with CROs to manage study execution in compliance with GLP and animal welfare guidelines.
- Lead mechanistic investigations into observed toxicities and propose risk mitigation strategies.
- Represent Pinetree in regulatory interactions and contribute to health authority responses.
- Stay current with advances in toxicology, emerging regulatory expectations, and innovative methodologies.
Qualifications
Education:
- PhD, DVM, or PharmD in Toxicology, Pharmacology, or a related life sciences discipline.
Experience:
- Minimum of 5–10 years of industry experience in toxicology, with demonstrated impact across development stages.
- Experience serving as a study director or monitor for general toxicology and/or safety pharmacology studies.
- Proven success in authoring regulatory documents and interacting with global regulatory agencies.
- Board certification (e.g., DABT) is preferred.
Skills:
- Deep understanding of regulatory toxicology and drug development paradigms.
- Strong leadership and cross-functional collaboration skills.
- Excellent written and oral communication, with ability to translate complex scientific concepts to broad audiences.
- Familiarity with major species used in toxicology testing (primarily NHPs and rodents).
- Ability to manage multiple projects, prioritize tasks, and influence decision-making processes.
What We Offer
- Competitive salary and bonus program.
- Comprehensive benefits including health, dental, and vision insurance
- 401(k) plan with company matching.
- Stock options/equity participation.
- Opportunities for professional growth and development in a dynamic biotech environment.
Pinetree is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Pinetree will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Recruitment & Staffing Agencies: Pinetree does not accept unsolicited resumes from any source other than candidates. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Pinetree, and Pinetree will not owe any referral or other fees with respect thereto.
Job Type: Full-time
Benefits:
- 401(k) matching
- Health savings account
Schedule:
- Monday to Friday
Education:
- Doctorate (Required)
Ability to Commute:
- Cambridge, MA 02138 (Required)
Ability to Relocate:
- Cambridge, MA 02138: Relocate before starting work (Required)
Work Location: In person
