Senior Director, Pharmacokinetics at Merck | CA, US | Rezi

Senior Director, Pharmacokinetics at Merck

Senior Director, Pharmacokinetics

Merck · CA, US

1 months ago

Senior Director, Pharmacokinetics

Merck · CA, US

2 months ago
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About the Role

The Pharmacokinetics, Dynamics, Metabolism and Bioanalysis (PDMB) organization is seeking a Senior Director to provide scientific, operational, portfolio, and people leadership for discovery programs. This role is accountable for shaping and executing bioanalytical strategies to deliver high-quality data supporting molecular design, candidate selection, translational interpretation, regulatory readiness, and portfolio decision-making. The Senior Director will also represent PDMB in discovery and/or development programs.

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.

Requirements

  • 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.
  • 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.
  • 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.
  • 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

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)

Location

  • Domestic/International

Work Type

  • Regular
  • 10% Travel

Experience Level

  • Senior Director
  • 15+ years (Master's)
  • 12+ years (Ph.D.)

Education Level

  • Master's Degree
  • Ph.D.

Salary/Compensations

  • $194,100.00 - $305,600.00

Benefits

  • Annual bonus and long-term incentive, if applicable.
  • Comprehensive package of benefits.
  • 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.

About the Company

  • Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.
  • Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
  • 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.

Equal Opportunity

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