JOB DESCRIPTION

Director/Sr. Director, Nonclinical Toxicology & Pharmacokinetics, #3096

Job #               #3096
Job Type:         Full-time, On-site
Location:         Greater Boston area

About the Company

Our client is a growing biotech company developing antibody therapies for protein degradation in oncology and Immune disorders. They have multiple programs advancing through development and are building an organization focused on translating discovery concepts into clinical candidates.

Benefits and Compensation

They offer competitive salaries and comprehensive benefits, including medical and dental insurance, paid time off, and a 401(k) with a generous company match. They are an equal-opportunity employer committed to a collaborative, multidisciplinary, and transformative company culture.

Position

We are seeking candidates for a Director or Sr. Director of Nonclinical Toxicology & Pharmacokinetics to provide scientific leadership across our client’s multi specific 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.

This role will report directly to the Chief Medical Officer (CMO)

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 multi-specific antibodies.
  • Veterinary training (DVM) and/or board certification (DABT, DACVP, ERT).
  • Experience supporting early clinical development (Phase I/II), particularly in oncology or immunology.

WANT TO LEARN MORE?
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*Our activities, as well as those of our client, are conducted to not discriminate against any applicant because of his/her race, color, religion (creed), gender, gender expression, age, National origin (ancestry), disability, marital status, or sexual orientation. This is an unofficial document prepared by CMCPositions.com to provide basic information concerning the position.   The company we are conducting this search for has the official job description.