Director / Sr. Director, Nonclinical Toxicology & PK

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.