Executive Director, PDMB Outsourcing

Merck; West Point (PA); On-site; USD 250,000 - 350,000; Full time

Job summary

Merck seeks an Executive Director to lead the Outsourcing team within Translational Sciences and Outsourcing (TSO). This leader will drive a digitally-connected outsourcing model, leveraging automation, data integration and AI to improve speed and decision-making across a global external network.

They will manage talent development, partner with cross-functional stakeholders, and ensure alignment of PDMB priorities with Merck's strategic framework.

Qualifications

• Broad experience in bioanalytical development/validation and quality control (QC) with expert knowledge of regulatory agency requirements for operating in a regulated clinical and GLP testing environment for both small molecules and biologics.
• Business and financial acumen including direct experience in forecasting, financial tracking and strat(egy).

Responsibilities

• Lead a team of scientists and operational staff within PDMB Outsourcing to ensure timely, compliant data generation at external partners.
• Oversee vendor strategy, external capability development, and budgetary/forecast guidance across DMPK, Reg BA, Procurement and Finance.
• Ensure flexibility and redundancy in the external network to buffer geopolitical risk and vendor performance issues.
• Drive innovation in external capabilities and internal sourcing/data processes.
• Align departmental priorities with TSO and PDMB strategic objectives; develop staff through performance management.

Skills

Bioanalytical development/validation

Regulatory requirements

Forecasting & budgeting

Education

BS/MS/PharmD with 13+ years experience

PhD or equivalent with 10+ years experience

Job description

Job Description

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.
• Overseeing external research at >50 vendors around the world to ensure quality, timeliness, compliance and assurance of supply through the Vendor Performance Process and by maintaining relationship with leaders at external partners.
• Driving innovation and continuous improvement in external capabilities and internal sourcing/data processes across DMPK, Reg BA, Procurement and Finance in close collaboration with those functions.
• Identifying resource needs and contributing to resource allocation internally and through management of business operations including travel and outsourcing budgets.
• Working with TSO leadership to contribute to the development and execution of departmental priorities and ensure broad alignment of individual priorities/performance of the team with the TSO and larger PDMB vision and mission. As a member of the PDMB extended leadership team, contribute to strategic discussions and execution of PDMB priorities.

Education:

• 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

Required Experience and Skills:

• Broad experience in bioanalytical development/validation and quality control (QC) with expert knowledge of regulatory agency requirements for operating in a regulated clinical and GLP testing environment for both small molecules and biologics.
• Business and financial acumen including direct experience in forecasting, financial tracking and strat