Responsibilities

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, supervising scientist and associate level reports, 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.

• Develop and implement DMPK platform to support discovery and development programs using internal and contracted external resources.
• Represent DMPK in multifunctional discovery and development project teams, for the collaborative optimization of compound design and development candidate profiling.
• Collaborate with other functions, but particularly pharmacology and toxicology to select appropriate preclinical toxicology species, establish/refine PK-PD and efficacy/safety relationships and provide human dose predictions.
• Contribute to the cross-functional review of regulatory documents and author and review DMPK sections for relevant regulatory documents e.g. IND, IB, MAA and serve as a subject matter expert in composing responses to regulatory queries.
• Identify, qualify, and engage external providers of in vitro ADME and in vivo PK services; analyze and interpret resulting data.
• 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 project issues.
• Adhere to the department budget, including laboratory supplies, external research grants, capital expenditures, contract research personnel and projects, and external project spending.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• PhD. in Pharmaceutical Sciences or related field of study with 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.
• 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.
• Exceptional 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 and drug-drug interactions.
• Track record of successful problem solving, scientific rigor and influencing of stakeholders, particularly in a drug project context to ensure that scientific and resource demands are aligned.
• Excellent managerial skills and experience fostering career development of direct and indirect reports.
• Demonstrated ability to influence and lead others.

The annual base salary for this role is $200,000 – $265,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.