Executive Director, PDMB Outsourcing

The department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking an Executive Director to lead the Outsourcing team within the Translational Sciences and Outsourcing (TSO) organization. The Executive Director will lead a team of scientists and operational staff with broad experience in the science across PDMB functions (Drug Metabolism and Pharmacokinetics (DMPK), vaccines Reg BA and therapeutics Reg BA), focusing on the sourcing, financial tracking and reporting processes in generating quality, timely, cost-effective and compliant data at external partners that drive decisions across the discovery and development portfolio.

The team is also responsible for tracking and forecasting outsourcing spend for each functional area and for maintaining financial compliance. The Executive Director will strengthen strategic partnerships with external providers by advancing a digitally-connected outsourcing model that leverages automation, data integration and fit-for-purpose AI to improve scientific insight, quality, speed and decision-making. This leader will connect wet-lab experimentation with dry-lab capabilities - including data science, modeling and analytics - to enable more predictive, efficient and scalable workflows across the external network.

They will also work with partners to adopt interoperable technologies, modernize data exchange and co-develop innovative capabilities that complement internal science and accelerate portfolio delivery. 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, and be responsible for talent development and performance management of their staff.

As a member of the TSO Leadership Team, the Executive Director will contribute to global scientific and portfolio strategy across TSO and the broader PDMB organization. They are expected to demonstrate exemplary ways of working, strong ethics, good negotiation skills and an enterprise mindset. The Outsourcing Executive Director role will be responsible for providing strategic leadership and talent management for the group through:
Leading a team of ~35 professionals, including Senior Directors, PhD and BS/MS level scientists, including people management, scientific and operational oversight, under the direction of the Associate Vice President of TSO. Providing strategic, high-level scientific, and operational leadership for the PDMB Outsourcing organization, including vendor strategy, new external capability development, assay/program placement, issue resolution, and budgetary/forecast guidance. Ensures flexibility and redundancy in external network to buffer against geopolitical risk, corporate changes at external partners, and vendor performance issues.

Delivering on the discovery and development portfolio across TAs and modalities (DMPK assays in discovery and development, GLP and clinical reg BA assays for therapeutics and vaccines from FIH through registration and post-marketing) to support internal program decisions and regulatory filings around the world, including close collaboration with adjacent sourcing functions to align strategy to best deliver on the portfolio and with functional leadership and drug development teams to ensure timely data delivery on critical milestones.

BS/MS/PharmD with at least 13 years of experience OR PhD or equivalent degree with at least 10 years of drug discovery or development experience including assay method development and validation

Broad experience in bioanalytical development/validation and quality…