- Is a motivated self-starter with excellent management capabilities and is a critical part of an innovative team that supports the company's drug discovery/development effort.
- Conceptualizes, develops, revises, and finalizes toxicology (GLP and non-GLP) study designs and reports; drafts nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., to ensure regulatory compliance.
- Manages and monitors nonclinical studies (GLP and non-GLP) at external CROs per Jazz standards and ensures that global regulatory/compliance requirements are met/exceeded.
- Critically reviews and edits CRO nonclinical toxicology study reports, analyzes and interprets data, defines PK/PD and PK/Toxicity correlations, partners in PK modeling and parameter estimation, and coordinates reports' finalization with CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements.
- Provides critical input on discovery and nonclinical development strategy including peer review of pharmacology/pharmacokinetic protocols, reports, and regulatory content.
- Leads and/or participates in cross functional teams as early development expert to ensure proper integration of these activities into overall project plans.
- Partners with and provides subject matter expertise to key internal functions (regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs) and their external contractors or collaborators.
- Maintains a current understanding of relevant literature and methodology, as well as the scientific literature related to the assigned Jazz pipeline products and R&D projects.
- Experience in outsourcing and monitoring toxicology studies, CRO management, and interacting with study directors and other vendors (e.g., consultants) to obtain timely delivery of clear, accurate, and well-written toxicology study reports with defensible data analyses and data interpretation. Capacity to propose practical mitigation (de-risking) strategies.
- Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations.
- Required experience in authoring non-clinical elements of major regulatory submissions (INDs, CTAs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., preparing science-based responses to regulatory questions.
- Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical safety assessment activities to support drug candidates' success at all stages of development.
- Ability to synthesize, interpret and integrate diverse, multidisciplinary scientific data (e.g., li>
- Experience in Discovery Toxicology as applicable to early stages (non IND-enabling) drug development would be a plus.
- Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents. li>
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Director, Medical Writing, Oncology - california, United States - Jazz Pharmaceuticals
Description
p>If you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter.
Brief Description:
The Director, Toxicology is accountable for managing the global nonclinical regulatory and investigative toxicology of assigned Jazz portfolio products, and likewise to support his/her reports overseeing those products. They will collaborate with their direct reports and other members of the toxicology group, Early Development non-clinical scientists, and members of Jazz cross-functional matrix teams to support the overall global nonclinical regulatory strategy of Jazz programs, from research to registration and beyond. The Director, Toxicology, reports to the Head of Toxicology.
Essential Functions
The eligible candidate is experienced in leading, supporting and managing direct reports. The Director, Toxicology has the necessary qualifications and experience for designing and conducting/monitoring toxicology studies at external CROs, interpreting and reporting toxicology findings, and enabling timely high-quality study deliverables. They will have the necessary experience for representing Toxicology in cross-functional teams supporting drug development programs and conveying Toxicology consensus position, identifying and pre-emptying potential toxicology issues that may slow or derail a program, and propose adequate de-risking strategies to address or circumvent such issues. p>
The Director, Toxicology:
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.
