Executive Director, Outsourcing & Bioanalytics Strategy

Merck; South San Francisco (CA); Hybrid; USD 256,000 - 403,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) and retirement benefits

Paid holidays & vacation

Sick days

Job summary

Merck & Co., Inc. is seeking an Executive Director to lead the Outsourcing team within Translational Sciences and Outsourcing (TSO). This role will guide a ~35-person team across PDMB functions, focusing on sourcing, forecasting and data quality with external partners to drive portfolio decisions.

The leader will integrate data science and AI-enabled workflows, align with enterprise priorities, and mentor staff to deliver timely, compliant data. A strategic, collaborative mindset is essential."

Qualifications

• Broad experience in bioanalytical development/validation and 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 forecasting, financial tracking and strategic vendor management.
• Demonstrated track record in building an inclusive and high-performance work environment through talent development, collaboration, driving results and managing teams.
• Excellent technical, communication (oral and written), interpersonal, and teamwork skills, with a positive attitude and proven performance record.

Responsibilities

• 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 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.

Skills

DMPK

Drug Metabolism

External Partners

Financial Acumen

Outsourcing

Pharmacokinetics

Strategic Leadership

Team Management

Education

BS/MS/PharmD with 13+ years experience

PhD or equivalent with 10+ years experience

Job description

Merck & Co., Inc. is seeking an Executive Director to lead the Outsourcing team within Translational Sciences and Outsourcing (TSO). This role will guide a ~35-person team across PDMB functions, focusing on sourcing, forecasting and data quality with external partners to drive portfolio decisions.

The leader will integrate data science and AI-enabled workflows, align with enterprise priorities, and mentor staff to deliver timely, compliant data. A strategic, collaborative mindset is essential."