Executive Director, Drug Metabolism and Pharmacokinetics (DMPK)

Job Description

The Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) department, is seeking an Executive Director to lead the Drug Metabolism and Pharmacokinetics (DMPK) team in West Point, PA. The leader of this group will have broad responsibilities in three interconnected areas – pipeline, talent, and strategy, and will be responsible for supporting the Neurosciences and Infectious Diseases discovery pipeline as well as a broad portfolio of programs at various stages of development across various therapeutic areas.   

Our company's DMPK Executive Director will enable the execution of the broad PDMB strategy and DMPK priorities including implementation of dynamic research operating plans (ROPs), translational and dose optimization strategies, and participation in therapeutic area-driven strategic discussions. The successful candidate will also contribute to the alignment of departmental and portfolio priorities within the company’s strategic framework. To achieve this, they will lead a team of talented scientists and partner with cross-functional stakeholders. Key deliverables include stage appropriate portfolio decisions, advancing lead identification, translational strategy, clinical candidate selection, starting clinical dose, assessing drug interaction risk and contributing to regulatory filings.

As a member of the DMPK Leadership team, the Executive Director will contribute to global scientific and portfolio strategy, talent development and will be responsible for site-specific business and operational aspects. They are expected to demonstrate exemplary ways of working, strong ethics, good negotiation skills and an enterprise mindset.

Key responsibilities:

• Accountable for strategic planning and scientific oversight of the discovery and development portfolio supported by the company's team.

• Responsible for resourcing and execution of mechanistic studies and the design of stage appropriate experiments in support of a pipeline consisting of diverse modalities and therapeutic mechanisms of action.

• Responsibilities range from early discovery through registration and life cycle management.

• Oversight of a highly trained group of scientists that provide support for the global pipeline, including Absorption, Distribution, Metabolism and Excretion (ADME), In Vitro Enzymology and Transporter as well as biotransformation data, including state-of-the-art capabilities.

• Partner closely with peers across the DMPK organization and with key PDMB and cross-functional stakeholders to identify and implement experimental and modeling solutions to progress programs and platforms.

• Advance the use of In Silico tools and modeling techniques to accelerate lead optimization/selection and the progression of clinical candidates with high probability of success.

• Oversee and participate in regulatory activities, including preparation of robust, fit for purpose submission packages based on deep understanding of regulatory expectations.

• Adjust and prioritize internal and external resources to efficiently support a rich and evolving pipeline for timely portfolio decision making and program progression.

• Contribute as functional area representative to governance committees ensuring that PDMB support aligned with portfolio objectives.

• Actively attract, develop, and retain talent.

• Collaborate with members of the Global DMPK leadership team to manage operational and financial aspects of the business. As member of the PDMB extended leadership team, contribute strategic discussions and execute on PDMB priorities.

• Demonstrate and foster a quality and compliance mindset

• Participate in licensing evaluations.

Qualifications

Required:

• PhD with 10+ years relevant experience OR Masters Degree with 15+ years of experience in a biopharmaceutical discovery and development organization.

• Experience in implementing effective ROPs, applying In Silico and experimental approaches in the discovery

• Ability to manage a broad portfolio, including small molecules, peptides and biologics.

• Command of ADME and PK/PD science to effectively address mechanistic and strategic questions related to efficacy and safety in relation to human exposure to influence program strategies, guide therapeutic design and candidate selection, and implementation of effective de-risking plans.

• Experience in building, leading, and managing teams with diverse experience and background to drive innovation and scientific excellence.

• Strong decision-making skills with an ability to focus on key objectives and forecast portfolio n