THE ROLE
The Head, Toxicologist will support the design of and monitor the execution of non-clinical safety programs to aid in the development of drug candidates from discovery to market authorization. The candidate will be highly motivated and contribute to a portfolio of projects in partnership with cross-functional R&D teams to support non-clinical safety evaluations and, in turn, the translation of new therapeutics candidates.
The Head, Toxicologist will also:
- Provide subject matter expertise, supporting decision-making and strategy with regards to non-clinical safety and regulatory interactions.
- Work with the Pharmacology team to design and execute non-clinical pharmacology studies.
- Advise the Preclinical Research team, providing important viewpoints in cross-functional meetings advancing therapeutic candidates.
- Help diligence external assets for potential in-licensing opportunities in partnership with the Business Development team.
Responsibilities
- Serve on interdisciplinary project teams with focus ranging from early-stage pre-clinical through regulatory submission and post-marketing support.
- Work closely with R&D, Program Management, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance, and others to support the planning and execution of non-clinical safety studies at appropriate stages to facilitate the progression of novel therapies through development without delay.
- Offer input regarding the selection of toxicology firms, CROs, and other external collaborators.
- Deliver updates to project teams and/or senior management, including implications for overall program goals and strategy.
- Concisely summarize safety study findings as part of the writing of regulatory documents, including (but not limited to) briefing books, investigational new drug (IND) applications, Investigator Brochures (IBs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
- Act as the company toxicology representative at and address non-clinical safety questions during interactions with regulatory authorities.
Requirements
- PhD or equivalent degree from an accredited institution in Toxicology, Pharmacology, or a related science, with 12+ years related experience;
- DABT certification is desirable.
- Broad knowledge in field of toxicology, with practical knowledge of pharmaceutical toxicology including:
- Approaches to discovery toxicology
- Relevant regulatory guidelines and preparation of submission documentation.
- Experience with NDA, BLA, MAA submissions is desirable.
- Experience collaborating with, monitoring, and auditing CROs prior to and during sponsored studies
- Ability to work and problem-solve effectively in a fast-paced team environment.
- Ability to communicate effectively both orally and in writing in an interdisciplinary environment.
Qualified candidates should email resume to tsharon@tseworldwide.com