Associate Director, DMPK

Research & Development   ·      Oxford, United Kingdom    ·       Full time

Location: Oxford, United Kingdom

Categories: Research & Development

Req ID: 6763

Job Description

Jazz 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 www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

The Associate Director, DMPK will provide DMPK leadership in the design, implementation, oversight, analysis, and reporting of nonclinical DMPK studies that support small and large molecule drug discovery and development teams.  The candidate will direct and monitor the activities of CROs to perform in vitro and in vivo DMPK/ADME studies that comply with regulatory guidelines for registration of small molecules and biologics.  Additionally, the candidate will oversee the preparation of nonclinical DMPK reports and relevant components of regulatory submissions, including IND, NDA/BLA. 

Key Responsibilities:

• Represent DMPK as the subject matter expert on multidisciplinary project teams, providing technical, scientific, and strategic leadership for all stages of drug discovery and early development
• Establish DMPK strategies that will enable project teams to achieve project goals within agreed upon timelines
• Provide input into the PK/TK aspects of nonclinical pharmacology and nonclinical toxicology studies
• Collaborate effectively with CROs to design and execute in vitro and in vivo studies aimed at characterizing the DMPK/ADME properties of drug candidates, ensuring studies are rigorously designed and comply with appropriate regulatory guidances (GLP, ICH, etc.)
• Initiate and manage contracts with CROs and academic partners
• Effectively communicate DMPK data and provide interpretation of results to project teams, senior management, and regulatory authorities
• Oversee the preparation of nonclinical DMPK/ADME reports and the relevant sections of documents for regulatory submissions (IND, NDA/BLA, etc)
• Manage CRO contracts and DMPK aspects of project budgets
• Participate in the assessment of in-licensing opportunities, as needed
• Travel up to 10% of time each year 

Minimum Requirements:

• PhD or BSc with equivalent experience in chemistry, biological sciences, pharmacology, or a related scientific discipline
• Demonstrated knowledge and expertise in DMPK to support nonclinical and clinical stage small molecule and/or biologic programs
• Relevant experience in the pharmaceutical or biotechnology industry, demonstrating a broad understanding of drug development
• Thorough knowledge of FDA, EMA, MHRA, and ICH guidance documents
• Proven ability to manage CROs
• Excellent written and oral communication skills
• Ability to think critically and solve problems independently
• Ability to navigate and work effectively in a fast-paced, matrix-team work environment
• Embody and model Jazz Pharmaceuticals’ core values (integrity, collaboration, passion, pursuit of excellence, and innovation)

Jazz Pharmaceuticals is an Equal Opportunity Employer.

Please click here to apply.