Director / Senior Director, Toxicology

5AM Ventures•Emeryville, CA

7d•$220,000 - $250,000

About The Position

Prolynx is seeking an experienced toxicology leader to build and direct nonclinical safety strategy as the company advances ultra-long-acting, hydrogel-based conjugate therapeutics toward and through clinical development. The role leads the toxicology function across the portfolio, assessing systemic safety of peptide payloads and serving as the primary nonclinical safety voice on program teams, with regulatory agencies, and with senior leadership. Prolynx uses an outsourced model for nonclinical safety. The role leads a global network of toxicology CROs and works with nonclinical consulting partners to design, execute, and monitor studies. The Director/Senior Director authors reports and regulatory documents and ensures studies are appropriately designed, conducted to GLP standards, and acceptable to regulators. As a member of the Preclinical Leadership Team, this role contributes to program strategy, resourcing, and go/no-go decisions with the Chief Scientific Officer and other functional leaders. The position is responsible for portfolio-wide nonclinical safety, integrating toxicology with DMPK, in vivo pharmacology, CMC, and clinical development from lead selection through IND and early clinical development. It also leads safety assessment of the delivery platform, including biocompatibility and clearance, alongside systemic toxicology of each payload; manages global CRO relationships, study quality, budgets, and timelines; and contributes to regulatory interactions and project-team leadership.

Requirements

PhD, DVM, or equivalent in toxicology, pharmacology, or a related discipline.
At least 10 years of toxicology experience in the biotech or pharmaceutical industry; 12 or more years strongly preferred.
Experience leading nonclinical safety strategy for programs through clinical development.
Extensive knowledge of GLP study design, safety pharmacology, and regulatory expectations for nonclinical safety packages, including ICH M3(R2), S7A/B, and related guidance.
Experience managing international CRO studies, with a strong record of execution and budget control.
Experience setting scientific strategy and influencing program and portfolio decisions at a leadership level, through functional leadership or project team leadership.
Clear, articulate communication skills.
Ability to work effectively with CROs, consultants, and regulators across cultures and time zones.
Collaborative experience working with diverse perspectives and multidisciplinary teams.
Demonstrated scientific rigor and creativity in research.
Ability to excel in nimble, fast-moving, outsourced environments.

Nice To Haves

DABT board certification.
Direct authorship of nonclinical sections of IND or IMPD submissions and participation in health authority interactions.
Experience with peptide, biologic, controlled-release, or depot drug products, including local tolerability and delivery-system biocompatibility.
Experience with incretin, amylin, or other metabolic therapies.
Experience qualifying degradation products, impurities, or PEGylated materials.
Experience with CRO auditing and data-integrity review.
Experience with 505(b)(2) or other bridging strategies for known active ingredients.
Familiarity with new approaches or methodologies that reduce animal use.
Strong statistical skills for in vivo study design and analysis, and ability to integrate complex datasets into drug development strategy.
Hands-on PK/PD or exposure-response modeling, for example with Phoenix WinNonlin, NONMEM, Monolix, or R, and human dose projection.

Responsibilities

Lead nonclinical safety for the portfolio, integrating toxicology with DMPK, in vivo pharmacology, CMC, and clinical development from lead selection through IND and early clinical development.
Design, oversee, and interpret GLP and non-GLP toxicology studies at CROs, including dose-range-finding, repeat-dose toxicology, safety pharmacology, genetic toxicology, and local tolerance studies.
Lead safety assessment of the delivery platform, including biocompatibility and clearance, as well as systemic toxicology of each payload.
Manage global CROs, including selection, qualification, GLP and data-integrity oversight, contracting, budgets, timelines, study logistics, shipments, and on-site or remote monitoring.
Define stage-specific safety data needs, make go/no-go recommendations, conduct exploratory safety studies, and develop safety plans for preclinical and clinical development.
Develop study strategies in line with regulatory guidance and the 3Rs; address payload class effects and appropriate safety margins; assess immunogenicity and hypersensitivity risks; and design combination toxicology strategies for pharmacokinetically matched multi-payload drugs.
Own preclinical development activities on program teams as a functional team member or project team lead.
Qualify and audit CROs globally; arrange independent pathology peer review; and ensure regulatory datasets are SEND-compliant.
Work with partners, review study reports and regulatory writing, and integrate findings into the safety strategy.
Author and critically review nonclinical safety sections of IND and IMPD submissions, Investigator's Brochures, briefing documents, and other regulatory documents; lead pre-IND and other nonclinical regulatory interactions; and potentially represent Prolynx before FDA and other health authorities.
Work with DMPK on toxicokinetics and safety margins relative to projected human exposure, and with Clinical Development on first-in-human dose selection and safety monitoring.
Work with CMC on impurity qualification and the safety of formulation and manufacturing changes.
Present integrated safety risk assessments to executive leadership.
Lead project teams for programs advancing through preclinical discovery and development.