Director, Clinical Pharmacology & Pharmacometrics

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Brief Description:

This position is responsible for leading efficient, innovative, clinical pharmacology and/or PK/PD studies from phase 1 to phase 4 through working with cross-functional team members.

Essential Job Functions:

Job Responsibilities

• Development of the clinical pharmacology strategy of multiple programs spanning from candidate nomination for GLP toxicity studies through phase 4
• Support clinical study protocol (phase 1-4) development, PKPD data analysis/interpretation, and study report
• Serve as the clinical pharmacology Lead at cross function teams, and responsible for the dose selection and rationale in phase 1 studies and contribute to dose selections in clinical studies beyond phase 1
• Work with the pharmacometrics lead and relevant cross-function teams to plan and support PKPD modeling for internal or regulatory decision makings
• Contribute to the preparation of relevant sections of regulatory submissions including IND, and NDA/BLA documents
• Address queries from regulatory agencies during reviews and inspections
• Identify and manage consultants and vendors supporting clinical pharmacology studies
• Contribute to the timely publication and/or presentation of clinical pharmacology and pharmacometrics data

Required Knowledge, Skills, and Abilities

• PhD or MD with significant years of experience in clinical pharmacokinetic and pharmacokinetic-pharmacodynamic studies and data analysis/interpretations
• Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process
• Good working knowledge of software for PK/PD analysis (e.g. Phoenix WinNonlin, R, ADAPT and NONMEM)
• Ability to work both independently and on strong cross functional teams
• Experience in regulatory submissions and agency interactions related to INDs, CTDs, NDAs or BLAs
• Excellent written and oral communication skills including good presentation skills
• Collaborative and flexible in personal interactions at all levels of the company

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

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.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits

Originally posted on Himalayas