Director Toxicology - Palo Alto, United States - Jazz Pharmaceuticals

Jazz Pharmaceuticals

Verified Company

Palo Alto, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Overview:

Position Profile:

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 Director, Toxicology:

Is a motivated selfstarter 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 nonGLP) study designs and reports; drafts nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., IB, DSUR, PSUR, etc.) to ensure regulatory compliance.
Manages and monitors nonclinical studies (GLP and nonGLP) 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.
Contributes to departmental processes such as SOP's, WI's and templates.
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.

Required Education, Licenses, Knowledge, Skills, and Abilities

As a minimum, Ph.

D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology with extensive pharmaceutical industry experience in drug development toxicology.

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

A minimum of 810 years of experience with small and large molecules with a preference for oncology and CNS indications.
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 wellwritten toxicology study reports with defensible data analyses and data interpretation. Capacity to synthesize and communicate complex information. Capacity to propose practical mitigation (derisking) strategies.
Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations.
Required experience in authoring nonclinical elements of major regulatory submissions (INDs, CTAs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., IB, PSUR, DSUR); preparing sciencebased responses to regulatory questions.
Ability to synthesize, interpret and integrate diverse, multidisciplinary scientific data (e.g., pharmacology, pharmacokinetics, pathology).
Experience in Discovery Toxicology as applicable to early stages (non INDenabling) drug development would be a plus.
Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents. Ability to interact effectively and tactfully with a variety of critical audiences within and outside the organization. Sense of urgency.
Enjoys and thrives in a fastpaced, multitasked, and handson environment.
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._