Senior Director, Pharmacokinetics

MSD; South San Francisco (CA); On-site; USD 194,000 - 306,000; Full time

Job summary

MSD in South San Francisco seeks a Senior Director to lead bioanalytical strategy across discovery programs, delivering fit-for-purpose assays and high-quality data to inform molecular design and decision making.

The role requires directing a diverse team of bioanalytical experts, partnering with ADME, PK/PD, translational and regulatory groups to enable development milestones and regulatory readiness. Strong leadership and collaborative skills are essential.

Qualifications

• Demonstrated scientific and operational leadership in bioanalysis including assay strategy, method development, validation or qualification, data interpretation, and reporting.
• Track record in bioanalytical approaches for biologics, conjugates, peptides, small molecules, and emerging modalities.
• Proven cross-functional discovery and development program experience integrating bioanalytical, ADME, PK, PK/PD, translational, regulatory considerations.

Responsibilities

• Provide scientific and portfolio leadership for bioanalytical strategy across discovery programs.
• Drive operational excellence via workflow optimization, automation, and data systems.
• Manage a team of bioanalytical leaders and scientists, enabling career development.
• Represent PDMB on cross-functional teams to guide program decisions.
• Review and present scientific documents and regulatory submissions for stakeholders.
• Foster a culture of innovation, collaboration, safety, quality, and compliance.

Skills

ADME

Bioanalysis

Bioanalytical Assays

Bioanalytical Methods

DMPK

Pharmacokinetics

PK/PD

Program Leadership

Translational PK/PD

Operational Leadership

Regulatory Readiness

Education

Master’s with 15+ years

Ph.D. with 12+ years

Job description

Job Description

The Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) organization is seeking an accomplished and highly collaborative Senior Director to provide scientific, operational, portfolio, and people leadership to support discovery programs across multiple therapeutic areas and therapeutic modalities. This leader will be accountable for shaping and executing fit-for-purpose bioanalytical strategies, enabling high-quality, timely data packages that support molecular design, candidate selection, translational interpretation, regulatory readiness, and portfolio decision-making. The Senior Director may also represent PDMB in discovery and/or development programs.

The successful candidate will serve as a senior scientific and operational leader for bioanalytical activities across a portfolio of biologics, small molecules, conjugates, and novel modality programs. This individual will directly manage and develop bioanalytical leaders, laboratory scientists, and program representatives, ensuring that team members are positioned to deliver high-impact scientific contributions, clear decision-enabling bioanalytical interpretation and effective project-team representation. The role will require close partnership with partner organizations to ensure integrated and data-driven support of the pipeline.

This position will be expected to strengthen scientific rigor in bioanalysis, harmonize workflows across internal and external networks where appropriate, drive operational excellence, modernize capabilities through automation and innovative technologies, and foster a high-performing, inclusive, and collaborative team culture.

Key Responsibilities

• Provide scientific and portfolio leadership for bioanalytical strategy across discovery programs, ensuring fit-for-purpose assay execution, data quality, compliance, and decision-making impact across biologics, conjugates, peptides, small molecules, and other emerging modalities.
• Drive operational excellence through workflow optimization, resource and capacity planning, automation, digital tools, data systems, and continuous improvement of bioanalytical processes. Promote harmonization and knowledge sharing across bioanalytical teams, sites, and external partners to improve consistency, flexibility, and responsiveness to changing portfolio needs. Monitor external scientific, technology, and regulatory trends in bioanalysis and related disciplines, and champion evaluation and implementation of new methodologies and best practices.
• Manage a team of DMPK team representatives, bioanalytical leaders/scientists, setting clear scientific expectations and enabling effective prioritization, execution, and career development.
• Represent PDMB on cross-functional discovery and development teams, integrating bioanalytical, ADME, PK/PD, translational, and regulatory perspectives to guide program decisions. Ensure PDMB deliverables support molecular design, lead optimization, candidate selection, nonclinical-to-clinical translation, first-in-human enablement, regulatory submissions, and clinical development planning.
• Serve as a scientific advisor or principal investigator for programs, platform initiatives, or cross-functional scientific workstreams.
• Build and maintain effective partnerships with discovery, development, translational, clinical, regulatory, and external collaborators to enable integrated pipeline support.
• Review, author, and present scientific documents, regulatory sections, technical reports, portfolio updates, and decision-making materials for internal and external stakeholders.
• Foster a culture of innovation, accountability, collaboration, inclusion, safety, quality, and compliance.

QUALIFICATIONS

Education:

• Master's (with 15+ years) or Ph.D. (with 12+ years) in pharmacokinetics, pharmaceutical sciences, bioanalytical chemistry, analytical chemistry, biochemistry, biology, pharmacology, immunology, bioengineering, or a related scientific discipline with significant experience in bioanalytical sciences, DMPK, drug discovery and development.
• Ph.D. (with 12+ years) in pharmacokinetics, pharmaceutical sciences, bioanalytical chemistry, analytical chemistry, biochemistry, biology, pharmacology, immunology, bioengineering, or a related scientific discipline with significant experience in bioanalytical sciences, DMPK, drug discovery and development.

Required Experience and Skills:

• Demonstrated scientific and operational leadership in bioanalysis, including assay strategy, method development, validation or qualification, sample analysis, data interpretation, and reporting.
• Track record demonstrating strong understanding of bioanalytical approaches relevant to biologics, conjugates, peptide, small molecule, and novel therapeutic modalities.
• Proven experience participating in cross-functional discovery and development program teams. Proven ability to integrate bioanalytical, ADME, PK, PK/PD, translational, toxicology, clinical pharmacology, and regulatory considerations to support program decisions.
• Demonstrated ability to manage a portfolio of programs by early strategy formation, prioritizing resources, aligning deliverables with milestones, identifying risks, and ensuring high-quality scientific execution. Demonstrated ability to develop DMPK representatives, bioanalytical leaders/scientists by strengthening scientific judgment, project-team leadership, communication, and decision-making impact.
• Proven people leadership experience, including management, mentoring, talent development, performance management, and building high-performing scientific teams. Demonstrated ability to lead through change, shape organizational capabilities, and develop future scientific and people leaders.
• Excellent written and verbal communication skills, with the ability to present complex scientific and operational topics clearly to technical, cross-functional, and senior leadership audiences.
• Strong collaboration and influencing skills, with demonstrated ability to build effective partnerships across functions, sites, and external organizations.
• Commitment to quality, safety, compliance, scientific rigor, operational excellence, and inclusive leadership.

Preferred Experience and Skills:

• Demonstrated ability to modernize workflows through automation, digital tools, data systems, assay harmonization, process improvement, or innovative bioanalytical technologies.
• Experience serving as scientific representative, or functional leader accountable for cross-function and/or cross-site collaboration.
• Familiarity with translational PK/PD, exposure-response, human dose projection, biomarker strategy, biodistribution assessment, immunogenicity risk assessment, or model-informed drug development.
• Experience supporting or leading programs involving drug conjugates, multispecific biologics or peptides. or other complex and emerging modalities
• Working knowledge of cell-based assays, biophysical or biochemical characterization.
• Track record of scientific visibility through publications, conference presentations, external collaborations, consortia participation, or cross-industry engagement.

Required Skills:

ADME, Bioanalysis, Bioanalytical Assays, Bioanalytical Methods, DMPK, Drug Discovery Development, Operational Leadership, Pharmacokinetics, Portfolio Strategies, Program Leadership, Scientific Leadership, Translational Pharmacokinetics and Pharmacodynamics (PKPD)

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:

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The salary range for this role is $194,100.00 - $305,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

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

Employee Status: Regular

Relocation: Domestic/International

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 09/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.