Director – Toxicology

This is a fully remote position, open to applicants in United States, +2 more countries.

📋 Description

• Oversee global nonclinical regulatory and investigative toxicology for designated Jazz portfolio products.

• Support the preparation of reports pertaining to assigned products.

• Collaborate with toxicology peers, Early Development nonclinical scientists, and cross-functional matrix teams.

• Assist in formulating global nonclinical regulatory strategies from research through to registration and beyond.

• Design, conduct, and supervise toxicology studies at external Contract Research Organizations (CROs).

• Analyze and report toxicology findings to ensure timely delivery of high-quality study outcomes.

• Act as the Toxicology representative on cross-functional teams engaged in drug development initiatives.

• Communicate Toxicology consensus positions while identifying potential toxicology challenges.

• Suggest de-risking strategies to mitigate or navigate toxicology concerns.

• Assess and prepare responses to inquiries from health authorities regarding global nonclinical development matters.

• Contribute to or lead early-development cross-functional teams.

• Create, revise, and finalize GLP and non-GLP toxicology study designs and reports.

• Draft nonclinical sections for IND/CTA and NDA/BLA submissions, along with other regulatory documents.

• Oversee and monitor GLP and non-GLP nonclinical studies conducted at external CROs.

• Review and refine CRO toxicology reports, analyze and interpret data, and establish PK/PD and PK/toxicity correlations.

• Collaborate in PK modeling and parameter estimation.

• Coordinate the finalization of reports with CROs following internal reviews and team discussions.

• Provide insights into discovery and nonclinical development strategy.

• Lead or engage in cross-functional teams as an expert in early development.

• Offer subject-matter expertise to Regulatory, Quality, Clinical, CMC and Formulations, Product Quality, Drug Safety, and Medical Affairs departments.

• Contribute to the development of departmental SOPs, work instructions, and templates.

• Stay updated on relevant literature, methodologies, assigned pipeline products, and R&D projects.

⛳️ Requirements

• Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, or Biology.

• Significant experience in the pharmaceutical industry, specifically in drug development toxicology.

• Board certification (e.g., DABT, ERT) is highly desirable, or demonstrable board eligibility with plans to take the board exam.

• Extensive experience with both small and large molecules, with a preference for oncology and CNS indications.

• Background in outsourcing and monitoring toxicology studies, managing CROs, and engaging with study directors and vendors.

• Ability to synthesize and convey complex information effectively.

• Capability to propose practical mitigation (de-risking) strategies.

• Strong familiarity with FDA, EMA, and ICH guidance documents as well as GLP regulations.

• Experience in authoring non-clinical components of major regulatory submissions, including INDs, CTAs, BLAs, NDAs, or sNDAs.

• Proficient in preparing science-based responses to regulatory inquiries.

• Comprehensive understanding of QA, regulatory, and clinical functions.

• Ability to synthesize, interpret, and integrate multidisciplinary scientific data, including pharmacology, pharmacokinetics, and pathology.

• Experience in Discovery Toxicology for early-stage drug development is a plus.

• Exceptional verbal communication and scientific writing skills.

• Ability to engage effectively and tactfully with key audiences both inside and outside the organization.

• A strong sense of urgency.

• Ability to excel in a fast-paced, multitasking, hands-on environment.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.