Executive Director, PDMB Outsourcing

Merck & Co.

Boston (MA)

Hybrid

USD 256,000 - 403,000

Full time

4 days ago

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Job summary

Merck & Co. in the USA is seeking an Executive Director to lead the Outsourcing team within the Translational Sciences and Outsourcing (TSO) organization.

You will oversee a global network of vendors and internal staff, aligning strategy, budget, and scientific programs across DMPK, Reg BA, and assay development to accelerate portfolio delivery. With responsibility for talent development, performance management, and strategic partnerships, you will drive automation, data integration and

Qualifications

Broad experience in bioanalytical development/validation and quality control (QC) with knowledge of regulatory agency requirements in regulated clinical and GLP testing for small molecules and biologics.
Financial forecasting, tracking and vendor management.
Proven ability to build talent, foster collaboration and drive innovation in a high-performance team.
Excellent communication and teamwork skills with a results-driven mindset.

Responsibilities

Provide strategic and scientific leadership for the PDMB Outsourcing organization, including vendor strategy and budget guidance.
Deliver portfolio support across DMPK, Reg BA, and assay programs to enable timely data delivery for filings.
Oversee >50 external vendors ensuring quality, compliance and timely data delivery.
Drive innovation, automation, and data integration across external and internal processes.

Skills

DMPK

Drug Metabolism

External Partners

Financial Acumen

Outsourcing

Pharmacokinetics

Strategic Leadership

Team Management

Education

BS/MS/PharmD

PhD or equivalent

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 strategic vendor management.
Demonstrated track record in establishing an inclusive and high-performance work environment through building talent, fostering collaboration, driving results and managing teams to drive innovation and scientific excellence
Excellent technical, communication (oral and written), interpersonal, and teamwork skills, with a positive attitude and proven performance record.

Preferred Experience and Skills:

Established leader in the field of bioanalytical science with a track record of external visibility through publications, presentations, regulatory engagement and/or involvement in professional organizations
Experience applying automation workflows in a regulated assay testing environment.
Experience with vaccine research and assay development, including a broad understanding of cell-based neutralization assays, ligand binding assays, and PCR/RT-PCR.
Experience with DMPK workflows for both small and large molecules.

Required Skills:

DMPK, Drug Metabolism, External Partners, Financial Acumen, Outsourcing, Pharmacokinetics, Strategic Leadership, Team Management

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is: USA - Pennsylvania - West Point

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$255,800.00 - $402,700.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day