Senior Director, Pharmacokinetics
Job in
South San Francisco, San Mateo County, California, 94080, USA
Listed on 2026-08-13
Listing for:
Merck
Full Time
position Listed on 2026-08-13
Job specializations:
-
Research/Development
Regulatory Compliance Specialist, Pharmaceutical Science/ Research, Biotech Research
Job Description & How to Apply Below
* 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.
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* Key Responsibilities:
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* + 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 work streams.
+ 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.
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* QUALIFICATIONS:
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* *
* Education:
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* + 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.
** Required
Experience and Skills:
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* + 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…
Position Requirements
10+ Years
work experience
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