Director, Pharmacokinetics

Job Description The Pharmacokinetics, Dynamics, Metabolism & Bioanalytics (PDMB) department at our company is seeking an accomplished scientific leader to head the Biotransformation (MetID) group within Drug Metabolism & Pharmacokinetics (DMPK). The Biotransformation Lead (Director) will drive our company's metabolite identification strategy and oversee a team of scientists who characterize drug metabolites across the discovery and development pipeline. The role ensures thorough metabolic profiling to support lead optimization, candidate selection, drug safety, efficacy, and regulatory compliance. Key Responsibilities Scientific Leadership – Provide strategic and technical leadership for the biotransformation/metabolite identification function, ensuring all major metabolites are identified and risks understood at each stage of development. Metabolite Identification & Mass Spectrometry – Oversee the design and execution of in vitro and in vivo MetID studies and apply state‑of‑the‑art LC‑MS/MS techniques for structural elucidation. Drug Development & MIST Compliance – Integrate metabolite findings into program decision making and ensure compliance with regulatory expectations (e.g., ICH M3(R2), FDA MIST). Identify human‑specific or disproportionate metabolites and recommend additional non‑clinical evaluations. Issue Resolution and Innovation – Anticipate metabolism‑related liabilities and propose risk‑mitigation strategies for safety or drug‑drug interaction concerns. Cross‑Functional Collaboration – Work closely with medicinal chemists, toxicologists, pharmacologists, and bioanalytical scientists to interpret metabolite data within the broader context of pharmacology and safety. Team Leadership and Mentorship – Lead and mentor a skilled MetID team, oversee priorities and resources, and champion scientific excellence. Data Interpretation and Reporting – Review and approve study reports and presentations; contribute to regulatory documents (INDs, NDAs) focused on metabolite identification and safety assessment. Qualifications (Required) Education & Experience – Ph.D. in Organic or Analytical Chemistry, Pharmacology, Pharmaceutical Sciences or related discipline with ≥8 years of relevant industry experience in drug metabolism (or MS with >12 years) and significant MetID experience in a pharmaceutical R&D setting. Metabolite Identification Expertise – Deep expertise with purification from biological matrices, LC‑MS/MS, high‑resolution mass spectrometry, and a strong publication record. Drug Development Knowledge – Broad understanding of ADME principles, non‑clinical and clinical metabolite exposure, design of in vitro metabolism studies, animal metabolism, human mass balance studies, and regulatory guidelines (ICH M3(R2), FDA MIST). Leadership & Collaboration – Proven ability to supervise or mentor scientists, manage workflow, communicate complex concepts, and handle multiple projects with strong organizational skills. Preferred Qualifications Regulatory & Late‑Stage Experience – Experience contributing to regulatory filings (NDA submissions) and responding to health authority queries on metabolism. Technical Innovations – Familiarity with emerging MetID technologies (automated data‑analysis software, novel MS fragmentation techniques, bioinformatics tools for predicting metabolites). Modalities Experience – Required experience with small‑molecule candidates and strong desire to work with peptide or protein therapeutics, understanding differential biotransformation. Required Skills ADME Analytical Chemistry Bioanalysis Cross‑Cultural Awareness Drug Development Drug Metabolism Innovation Mass Spectrometry (MS) Mentoring Staff Pharmaceutical Analysis Pharmacokinetics Pharmacology Physiology Regulatory Compliance Results‑Oriented Scientific Leadership Strategic Direction Talent Development Team Leadership Preferred Skills We encourage qualified applicants who can contribute to a dynamic, inclusive team. Salary Range $173,200.00 – $272,600.00 Benefits We offer a comprehensive benefits package, including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. Employment Details Employee Status: Regular Relocation: Domestic Visa Sponsorship: Yes Travel Requirements: 10% Valid Driving License: No Hazardous Materials: N/A Flexible Work Arrangements: Not Applicable Shift: Not Indicated Job Posting End Date 06/12/2026 Requisition ID R386512 Equal Opportunity Employer Our company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or any other factor protected by applicable law. EEO Statement 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. 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 the EEOC website. #J-18808-Ljbffr