Provide leadership in design, implementation, oversight, analysis and reporting of nonclinical DMPK programs to support small and large molecule drug development including health authority required studies through registration and post-marketing
Essential Job Functions:
This position has varying responsibilities relating to nonclinical and clinical drug development, which include but are not limited to:
- Establishing the overall strategic direction for the assessment of Drug Metabolism and Pharmacokinetic aspects of drug products consistent with the company’s and research & development organization’s goals.
- Manage internal and external relationships and resources to enable DMPK characterization of drug candidates at all stages of development.
- Planning, preparing and reviewing drug development plans and regulatory filings. This involves determining the scope, protocol design study planning & oversight, data review / analysis / interpretation, and reporting for all DMPK studies implemented to support nonclinical assessment and development.
- Driving human dose projection/modeling to support clinical trial design as well as contributing to clinical pharmacology trial design regarding prediction of DDI potential
- Selection and management of CROs performing non-GLP and GLP nonclinical studies. Initiate and manage contracts, coordinate activities with contract laboratories and academic partners
- Contribute to Early Development departmental processes such as SOP’s and templates
- Ensure a high quality of work and compliance to appropriate regulatory guidances are followed, including the Good Laboratory Practice (GLP) regulations, ICH, and other regional guidance documents for DMPK assessment of biopharmaceutical molecules.
- Represent Jazz in interactions with regulatory agencies and respond to regulatory inquires related to nonclinical content. Responsibilities would also include describing results of these studies in various regulatory documents (INDs, NDAs, IBs, etc.)
- Participation on cross functional teams as an Early Development representative to ensure proper integration of these activities into overall project plans
- Partner with and provide subject matter expertise to key internal constituencies (regulatory, Quality, Clinical, CMC and formulations, Drug safety, Medical affairs) and their external contractors or collaborators.
- Participate in the evaluation of potential in-licensing candidates. Serve as early development sciences representative on teams evaluating candidates for in-licensing or risk sharing opportunities
- 10% to 20% Travel Required
- PhD in pharmacology or relevant discipline.
- Extensive knowledge and demonstrated expertise in DMPK and bioanalytical sciences to support nonclinical and clinical stage programs
- 5-10 years of related experience in the pharmaceutical or biotechnology industry, demonstrating a broad and proven understanding of drug development.
- Thorough working knowledge of FDA and ICH guidance documents
- Ability to work effectively independently and in teams, with peers, and with senior management to move projects forward.
- 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