Senior Vice President, Toxicology
Listed on 2026-07-18
-
Research/Development
Regulatory Compliance Specialist, Research Scientist
The Company is seeking an experienced and strategic leader to serve as Senior Vice President, Toxicology. This executive will own and advance the nonclinical safety function at an enterprise level, serving as the senior-most authority on nonclinical safety strategy and a standing member of the R&D leadership team. The SVP will set the scientific and operational direction for toxicology across the Company's full degrader pipeline from early target assessment through late-stage clinical development, regulatory approval, and post-market surveillance.
Reporting directly to the Chief Scientific Officer, the SVP will lead and scale the internal toxicology team, own external CRO relationships, and serve as the Company's primary representative in interactions with FDA, EMA, and other health authorities. This individual will contribute to portfolio-level go/no-go decisions and help define the nonclinical development paradigm for targeted protein degradation as a modality.
This is a role for a builder and a scientific leader with the depth to advance a complex degrader pipeline, the executive presence to represent the Company externally, and the organizational instincts to develop a high-performing toxicology function from within.
Responsibilities- Define and own the enterprise-wide nonclinical safety strategy for the Company's portfolio, from early discovery and lead identification through IND, clinical development, registration, and post-approval commitments; accountable for the scientific rigor and regulatory defensibility of all toxicology programs.
- Serve as the senior toxicology executive and primary scientific authority on all matters of nonclinical safety, risk assessment, and regulatory strategy; hold a standing seat on the R&D leadership team, cross-functional program governance, and portfolio-level go/no-go decision forums.
- Support external scientific engagement activities as needed, including preparation of nonclinical data packages for scientific presentations and regulatory interactions.
- Contribute nonclinical safety expertise to external scientific discussions as requested by leadership.
- Cultivate and maintain an active external network of toxicology and nonclinical safety leaders across the biopharma industry, academic institutions, and regulatory agencies to inform best practices and advance the Company's scientific reputation in the field.
- Sponsor, oversee, and provide scientific direction for the full spectrum of nonclinical studies, including safety pharmacology, single- and repeat-dose toxicology, genotoxicity, reproductive and developmental toxicology, and carcinogenicity as applicable, executed through strategically managed CRO partnerships.
- Establish and govern the Company's CRO and external laboratory partner strategy; select, contract, and provide scientific and quality oversight of CRO relationships across multiple concurrent programs and modalities.
- Author, review, and approve nonclinical sections of all regulatory documents including INDs, CTAs, IBs, DSURs, NDAs/BLAs, pediatric investigation plans, and responses to agency queries; ensure all nonclinical packages meet applicable ICH guidelines and agency expectations.
- Lead the Company's representation in Type A/B/C FDA meetings, pre-IND interactions, and face-to-face engagements with EMA, PMDA, and other international regulatory authorities; prepare and present nonclinical data packages and safety arguments at the executive level.
- Build, lead, and develop the internal toxicology organization; define team structure, roles, and growth pathways appropriate to the Company's pipeline stage; attract and retain top-tier scientific talent in a competitive market.
- Develop and manage the toxicology budget; provide forward-looking resource and investment guidance to the CSO and CFO aligned with portfolio priorities and clinical timelines.
- Translate mechanistic understanding of targeted protein degradation biology, including ternary complex formation, on-target/off-target degradome effects, E3 ligase tissue distribution, and modality-specific safety liabilities, into differentiated nonclinical safety strategies that anticipate regulatory questions and support clinical risk management.
- Partner with Chemistry, Biology, DMPK, and Clinical Development during lead optimization and candidate selection to integrate safety-relevant structure-activity relationships, early toxicology data, and translational risk assessments into candidate progression decisions.
- Communicate nonclinical safety findings, risk assessments, and strategic recommendations with clarity and confidence to cross-functional teams, executive leadership, the Board, and regulatory agencies.
- Travel required as needed.
- Ph.D. in Toxicology, Pharmacology, or a closely related discipline with a minimum of 18 years of progressive industry experience, including significant tenure in a toxicology function-head or executive leadership role; or a D.V.M./M.D. with equivalent experience and…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).