Jazz Pharmaceuticals

Sr. Director, Clinical Pharmacology

US-CA-Palo Alto
2 weeks ago
Job ID
2017-3283
# of Openings
1
Category
Research & Development

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Profile

This position will provide leadership in design, oversight, analysis and reporting of clinical pharmacology programs to support small and large molecule drug development from concept stages through registration and post-marketing.

As a member of the Jazz team, you will share our commitment to improving patients’ lives.  You will be responsible for providing clinical pharmacology and DMPK expertise to project teams, writing assigned sections of protocols and reports, and preparing documentation for regulatory submissions. As a clinical pharmacologist at JAZZ, you will lead efforts to understand the PKPD of drugs so they can be used effectively and safely. As a DMPK expert, you will leverage your broad expertise in pharmacokinetics and drug metabolism to design and manage projects ranging from early to late-stage development.  You will interact with multidisciplinary groups across the company including clinical development, biostatistics, clinical operations, regulatory, nonclinical, development, quality, and business development.  You will demonstrate a commitment to Jazz core valuesintegrity, collaboration, passion, pursuit of excellence and innovation.

Essential Functions

This position has varying responsibilities relating to clinical pharmacology, pharmacokinetics and pharmacodynamics which include but are not limited to:

  • Planning, preparing and reviewing drug development plans and regulatory filings. This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamic studies, investigations, and modeling/simulations required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.  Responsibilities include describing results of these studies in various regulatory documents (IND’s NDA’s, IB’s, etc.)
  • Protocol design, study planning, review, data analysis / interpretation, and reporting  of individual studies implemented to support clinical pharmacology components of project plans
  • Collaborating with early development colleagues on the scientific/technical aspects of assigned studies from conception through final report, including protocol development, budget (as appropriate), timelines, sample handling/processing, bioanalysis (through CRO), and PK data analysis/interpretation.
  • Identifying and managing consultants and vendors supporting clinical pharmacology
  • Participation on cross functional teams as early development sciences expert to insure proper integration of these activities into overall project plans
  • Representing Jazz in interactions with regulatory agencies and responding to regulatory inquires related to DMPK, PKPD, and clinical pharmacology
  • Participating in the evaluation of potential in-licensing candidates. Serve as early development sciences expert representative on teams evaluating candidates for in-licensing or risk sharing opportunities

Required Knowledge, Skills, and Abilities

  • Ability to work effectively independently and in multi-disciplinary teams, with peers, and with senior management to move projects forward
  • Experience interacting with regulatory agencies including being directly involved in the review process
  • Must have been directly involved with successful major regulatory filings
  • Must have hands on experience preparing regulatory documents from IND through NDA
  • Expertise in providing CRO and consultant oversight
  • Excellent written and oral communication skills
  • Ability to think critically and solve problems
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • Embody and model Jazz core values

Required/Preferred Education and Licenses

  • This position requires an MD or Ph.D. in pharmacokinetics, clinical pharmacology, or a related science and 12 or more years of related experience in the pharmaceutical or biotechnology industry, to include a broad and proven understanding of drug development.

Description of Physical Demands

  • Routine mobility within office environment.
  • Routine sitting for extended periods of time.
  • Operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Routine computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

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.

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