Director, Nonclinical Toxicology & PK – Biologics (Remote)

Pinetree Therapeutics, Inc; Cambridge (MA); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Equity participation

Job summary

Pinetree therapeutics is seeking a Director or Sr. Director of Nonclinical Toxicology & PK to lead integrated nonclinical safety and PK for multispecific antibody programs. This role may be remote or hybrid, with 2–4 onsite days monthly.

The candidate should have a PhD, DVM, or equivalent advanced degree and 10+ years in nonclinical safety, with hands-on PK/TK and CRO management experience to support FIH dosing strategies and regulatory submissions.

Qualifications

• PhD, DVM, PharmD, or equivalent advanced degree in toxicology or related field.
• 10+ years of progressive experience in nonclinical safety and drug development.
• Track record leading nonclinical safety strategy for biologics through IND-enabling development.
• Hands-on PK/TK assessments using industry tools and CRO management.
• Strong regulatory experience, including IND sections and health authority interactions.
• A proven ability to work independently within a multidisciplinary project team.

Responsibilities

• Own the integrated nonclinical safety and PK strategy from discovery through IND and early clinical development.
• Design and apply tissue cross-reactivity strategies to identify safety risks.
• Lead non-GLP and GLP toxicology programs, including DRF and repeat-dose studies.
• Provide PK/TK leadership and NOAEL/FIH dose rationale with CRO partners.
• Author nonclinical sections of INDs/CTAs and support regulatory interactions.
• Establish CRO governance and best practices.

Skills

Nonclinical safety leadership

PK/TK analysis

Regulatory writing

CRO management

IND/CTA preparation

Education

PhD, DVM, PharmD or equivalent advanced degree in toxicology/pharmacology/veterinary medicine or related discipline

Job description

Pinetree therapeutics is seeking a Director or Sr. Director of Nonclinical Toxicology & PK to lead integrated nonclinical safety and PK for multispecific antibody programs. This role may be remote or hybrid, with 2–4 onsite days monthly.

The candidate should have a PhD, DVM, or equivalent advanced degree and 10+ years in nonclinical safety, with hands-on PK/TK and CRO management experience to support FIH dosing strategies and regulatory submissions.