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.
This position has varying responsibilities relating to clinical pharmacology, pharmacokinetics and pharmacodynamics which include but are not limited to:
- Establishing the strategic direction for the clinical pharmacology component of drug development programs consistent with company and R&D program goals
- 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, models and 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
- 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
- Represent Jazz in interactions with regulatory agencies and respond to regulatory inquires related to pk, pd and clinical pharmacology
- Participate 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
- Proven ability to manage CRO's and consultants
- 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.