Recruiting

Director / Sr. Director, Nonclinical Toxicology & PK

Pinetree therapeutics

25.11.05

Location: Cambridge, MA (On-site) Reports to: Chief Medical Officer (CMO) Role Type: Full time, on-site

About Pinetree Therapeutics Pinetree Therapeutics is a rapidly growing biotechnology company developing next generation multispecific antibody therapies in oncology and immune modulation. With multiple programs advancing through IND-enabling development, we are building a highly collaborative, science-driven organization focused on translating innovative discovery concepts into first-in-class clinical candidates.

Position Summary We are seeking an experienced Director or Sr. Director of Nonclinical Toxicology & PK to provide scientific leadership across our multispecific antibody portfolio. Operating independently, this individual will take full ownership of a pipeline project, defining and executing integrated nonclinical safety, PK, and clinical translation strategies from early feasibility through IND-enabling development.

The ideal candidate is a tox-first, biology-driven drug developer with deep experience advancing biologics into the clinic. You will be responsible for designing and overseeing preclinical and GLP toxicology studies, assessing tissue cross-reactivity, and managing PK assessments (both hands-on and via CROs) to support First-in-Human (FIH) dose estimations.

Key Responsibilities

Integrated Nonclinical Safety Strategy: Own the integrated nonclinical safety and PK strategy for assigned antibody programs from discovery through IND and early clinical development. Serve as the nonclinical safety lead on cross-functional program teams.
Discovery Tox & Tissue Cross-Reactivity: Partner with Discovery teams to design and apply strategies that identify and mitigate safety risks early. Define and apply fit-for-purpose assays to evaluate target cross-reactivity and tissue binding.
Toxicology Study Leadership: Design, oversee, and interpret non-GLP and GLP toxicology programs, including dose-range finding (DRF) studies, repeat-dose toxicity, and safety pharmacology in relevant species. Provide scientific oversight of CRO-executed studies, ensuring data quality and regulatory alignment.
PK & Clinical Translation: Provide scientific leadership for nonclinical PK/TK strategy, study design, and interpretation. Perform hands-on PK/TK analysis (e.g., using Phoenix WinNonlin) and oversee advanced PK modeling and FIH starting-dose rationale (e.g., MABEL, NOAEL) in collaboration with CRO partners.
Regulatory Leadership: Author, review, and integrate nonclinical safety and PK sections of INDs/CTAs, Investigator’s Brochures, and regulatory briefing documents. Represent nonclinical development in FDA and global health authority interactions.
Organizational Leadership: Establish scalable nonclinical safety standards appropriate for an outsourced biotech model, including CRO governance and best practices.

Qualifications

Required:

PhD, DVM, PharmD, or equivalent advanced degree in toxicology, pharmacology, veterinary medicine, or a related discipline.
10+ years of progressive experience in nonclinical safety and drug development within biotech and/or pharmaceutical organizations.
Demonstrated track record leading nonclinical safety strategy for biologic therapeutics through IND-enabling development.
Hands-on experience designing and overseeing early discovery toxicity studies, tissue cross-reactivity assessments, DRF, and GLP toxicology studies.
Hands-on experience conducting PK/TK assessments using industry-standard software (e.g., Phoenix WinNonlin), alongside the ability to effectively manage CROs for advanced modeling and FIH dose estimation.
Strong regulatory experience, including authorship of nonclinical IND sections and participation in health authority interactions.
A demonstrable track record of success in functioning independently as an integral part of a multidisciplinary project team.

Preferred:

Experience with complex antibody modalities, including bi- or multispecific antibodies.
Veterinary training (DVM) and/or board certification (DABT, DACVP, ERT).
Experience supporting early clinical development (Phase I/II), particularly in oncology or immunology.

Compensation & Benefits We offer a highly competitive compensation and benefits package, including equity participation that reflects the strategic importance of this role. Pinetree offers comprehensive benefits, including medical and dental insurance, paid time off, and 401(k) with a generous company match.

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