Director / Sr. Director, Nonclinical Toxicology & PK

Pinetree Therapeutics, Inc; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Equity participation

Medical and dental insurance

Paid time off

401(k) match

Job summary

Pinetree Therapeutics, Inc is seeking a Director or Senior Director of Nonclinical Toxicology & PK to provide scientific leadership across multispecific antibody programs. You will own nonclinical safety, PK, and clinical translation strategies from discovery through IND-enabling development, designing and overseeing GLP studies and CRO collaborations.

The ideal candidate is tox-first, biology-driven, with deep experience advancing biologics into the clinic and a track record in regulatory

Qualifications

• PhD, DVM, PharmD or equivalent in toxicology, pharmacology or related field.
• 10+ years leading nonclinical safety and drug development in biotech/pharma.
• Led nonclinical safety strategy for biologics through IND-enabling development.
• Hands-on PK/TK assessments and CRO management for advanced modeling.
• Regulatory experience including IND sections and health authority interactions.

Responsibilities

• Own integrated nonclinical safety and PK strategy for antibody programs through IND.
• Design and oversee non-GLP/GLP toxicology programs and CRO studies.
• Lead PK/TK strategy, study design, and interpretation; advise on FIH noael/MABEL.
• Author nonclinical sections of INDs/CTAs and regulatory briefing documents.
• Establish scalable nonclinical safety standards for outsourced model.

Skills

Leadership

Nonclinical safety strategy

PK/TK analysis

Regulatory leadership

Independent project leadership

Education

PhD, DVM, PharmD or equivalent

Tools

Phoenix WinNonlin

Job description

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.