Job Summary
The successful candidate will have a proven track record of working in the ADME/DMPK area supporting R&D programs. They will have experience with working in a highly collaborative team environment, interfacing with multiple departments across the organization and developing strategic relationships with preferred vendors. They will work closely with other nonclinical disciplines such as toxicology and bioanalytical, and ensure that nonclinical objectives for programs are achieved.
Key Responsibilities
* Design and coordinate nonclinical studies to understand the pharmacokinetics and absorption, metabolism, distribution, and excretion of molecules
* Represent DMPK in multifunctional discovery and development project teams, for the collaborative optimization of compound design and project Design/Make/Test cycles, and for development candidate profiling
* Collaborate with other functions, but particularly pharmacology and toxicology to select appropriate preclinical toxicology species, establish/refine PK-PD efficacy/safety relationships and provide human dose predictions
* Ensure that appropriate DMPK studies are included in program plans and timelines
* Responsible for the analysis, interpretation, integration, and reporting of preclinical DMPK data
* Contribute to the cross-functional review of regulatory documents and author and review DMPK sections for relevant regulatory documents e.g. IND, IB, and be accountable for their quality in support of regulatory submissions
* Serve as a subject matter expert in composing responses to regulatory queries
* Identify, qualify, engage, and manage external providers of in vitro ADME and in vivo PK services; analyze and interpret resulting data
* Provide in-depth scientific expertise and technical leadership as well as resource and relationship management of external networks
* Deliver and communicate results to project teams and other stakeholders to enable decision making
* Recommend, initiate, lead and champion new innovations from external, global and local sources to ensure cutting-edge science is applied to drug project issues
Professional Experience and Qualifications
* PhD or equivalent in a relevant scientific discipline
* A minimum of 10+ years of discovery and development experience in pharmaceutical/biotech R&D supporting ADME/PK
* Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles
* Hands on experience with in vitro and vivo ADME/PK studies and an in-depth understanding of study design, data interpretation and how ADME/PK studies contribute to the discovery and development process
* Experience working with external vendors to provide ADME/PK support for programs
* Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge
* Up to date knowledge on regulatory guidance related to ADME/PK characterization, drug-drug interactions
* Experience designing and critically evaluating results of exploratory and GLP-compliant studies
* Team player with strong negotiation, problem-solving, and strategic influencing skills
* Strong customer focus with the ability to have robust discussions with project leaders and other stakeholders to ensure that project, scientific and resource demands are aligned
* Track record of successful problem solving, high quality science and influencing of stakeholders, particularly in a drug project context