Director – Toxicology

🔥 17 hours ago

🌐 United States, United Kingdom, +1 more countries – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote 🇨🇦 Canada – Remote

💵 $204k - $306k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Manage global nonclinical regulatory and investigative toxicology for assigned Jazz portfolio products • Support reports overseeing assigned products • Collaborate with toxicology colleagues, Early Development nonclinical scientists, and cross-functional matrix teams • Support global nonclinical regulatory strategies from research through registration and beyond • Design, conduct, and monitor toxicology studies at external CROs • Interpret and report toxicology findings and enable timely, high-quality study deliverables • Represent Toxicology on cross-functional teams supporting drug development programs • Convey Toxicology consensus positions and identify potential toxicology issues • Propose de-risking strategies to address or circumvent toxicology issues • Evaluate and prepare responses to health-authority inquiries on global nonclinical development issues • Contribute to or lead early-development cross-functional teams • Develop, revise, and finalize GLP and non-GLP toxicology study designs and reports • Draft nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents • Manage and monitor GLP and non-GLP nonclinical studies at external CROs • Review and edit CRO toxicology reports, analyze and interpret data, and define PK/PD and PK/toxicity correlations • Partner in PK modeling and parameter estimation • Coordinate report finalization with CROs after internal review and team communication • Provide input on discovery and nonclinical development strategy • Lead or participate in cross-functional teams as an early-development expert • Provide subject-matter expertise to Regulatory, Quality, Clinical, CMC and Formulations, Product Quality, Drug Safety, and Medical Affairs functions • Contribute to departmental SOPs, work instructions, and templates • Maintain current knowledge of relevant literature, methodologies, assigned pipeline products, and R&D projects

🎯 Requirements

• Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology • Extensive pharmaceutical industry experience in drug development toxicology • Board certification (e.g., DABT, ERT) highly desirable, or demonstrable board eligibility with the intention to write the board exam • Extensive experience with small and large molecules, with a preference for oncology and CNS indications • Experience outsourcing and monitoring toxicology studies, managing CROs, and interacting with study directors and vendors • Capacity to synthesize and communicate complex information • Capacity to propose practical mitigation (de-risking) strategies • Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations • Experience authoring non-clinical elements of major regulatory submissions, including INDs, CTAs, BLAs, NDAs or sNDAs • Experience preparing science-based responses to regulatory questions • Deep 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 • Excellent verbal communication and scientific writing skills • Ability to interact effectively and tactfully with critical audiences inside and outside the organization • Sense of urgency • Ability to thrive in a fast-paced, multitasked, 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