Director, Pharmacokinetics

Merck•Upper Gwynedd Township, PA

13h•Hybrid

About The Position

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 play a pivotal role in guiding our company's discovery and development projects through the lens of drug metabolism, ensuring that metabolite profiles are elucidated and understood to de-risk safety, optimize efficacy, and satisfy regulatory expectations. This position offers the opportunity to lead a talented team and drive scientific excellence in a key discipline within DMPK, contributing directly to the advancement of our company's pipeline. The lead will drive our company's metabolite identification strategy and operations, overseeing a team of scientists responsible for characterizing drug metabolites across the discovery and development pipeline. This leader will ensure that the metabolism of therapeutics is thoroughly profiled in support of lead optimization, candidate selection, drug safety, efficacy, and regulatory compliance. The ideal candidate has deep expertise in drug metabolism, including biotransformation mechanisms, in vitro and in vivo tools, and state of the art instrumentation used in support of metabolite identification and structural elucidation. A strong background in drug development (from preclinical studies through clinical trials), and an in-depth understanding of metabolite exposure in both non-clinical (animal) and clinical risk assessment are key to success in this role. Extensive small molecule experience will be critical for this position while experience with other modalities (e.g. peptide therapeutics) is preferred.

Requirements

Education & Experience: Ph.D. in Organic or Analytical Chemistry, Pharmacology, Pharmaceutical Sciences or a related discipline with at least 8 years (or an MS degree with > 12 years) of relevant industry experience in drug metabolism, including significant experience with metabolite identification in a pharmaceutical R&D setting.
Metabolite Identification Expertise: Deep expertise in metabolite identification and biotransformation science. Extensive hands-on experience with structural assignment techniques, including purification from biological matrices, LC‑MS/MS and high-resolution mass spectrometry, supported by a strong publication record.
Drug Development Knowledge: Broad knowledge of ADME and drug metabolism principles across discovery and development. Understanding of both non-clinical and clinical aspects of metabolite exposure – including design of in vitro metabolism studies (e.g. hepatocyte/metabolic stability, enzyme phenotyping) and in vivo studies (animal metabolism and human mass balance studies). Familiarity with regulatory guidelines on metabolites (e.g. ICH M3(R2) and FDA MIST guidance) and experience ensuring compliance with metabolite safety assessment requirements.
Leadership & Collaboration: Proven leadership skills in a scientific setting. Prior experience in supervising or mentoring other scientists is required, with ability to manage a team’s workflow and develop talent. Excellent interpersonal as well as oral and written communication skills are a must, including ability to convey complex concepts succinctly to broad audiences. Strong organizational and project management abilities to handle multiple projects concurrently and meet deadlines are expected.

Nice To Haves

Regulatory & Late-Stage Experience: Experience contributing to regulatory filings (NDA submissions) by authoring metabolite sections or responding to health authority queries on metabolism is a plus.
Technical Innovations: Familiarity with emerging technologies in metabolite identification (such as automated data analysis software, novel mass spec fragmentation techniques, or bioinformatics tools for predicting metabolite formation) is a plus.
Modalities Experience: Experience with small-molecule drug candidates is required, and experience with peptide or protein therapeutics is strongly desired. The candidate should understand how biotransformation of peptides/proteins may differ.

Responsibilities

Scientific Leadership: Provide strategic and technical leadership for the biotransformation/metabolite identification function. Accountable for comprehensive metabolite profiling of drug candidates from early discovery through late-stage development, ensuring all major metabolites are identified and potential risks are understood at each stage. This includes guiding metabolite ID efforts for discovery programs (e.g. lead optimization) as well as development programs (candidate selection, IND enabling studies, clinical trials, and human ADME studies).
Metabolite Identification & Mass Spectrometry: Oversee the design and execution of in vitro and in vivo MetID studies to characterize metabolites in relevant matrices (plasma, urine, bile, etc.). Leverage established as well as state-of-the-art mass spectrometry and analytical techniques for structural elucidation of metabolites (e.g. high-resolution LC-MS/MS).
Drug Development & MIST Compliance: Apply broad drug development expertise to integrate metabolite findings into program decision-making. Ensure that metabolite identification strategy meets regulatory expectations. This includes identifying any human-specific or disproportionate metabolites and identifying/highlighting additional non-clinical evaluations as needed.
Issue Resolution and Innovation: Anticipate and address metabolism-related liabilities in drug candidates. Proactively identify potential metabolite-related safety or DDI concerns (e.g. reactive intermediates, genotoxic metabolites, significant species differences in metabolism) and propose risk-mitigation strategies.
Cross-Functional Collaboration: Collaborate closely with medicinal chemists, toxicologists, pharmacologists and bioanalytical scientists to ensure metabolite data are interpreted in context of pharmacology and safety. Provide expert guidance to project teams on metabolite considerations and derisking strategies (e.g. informing structure design to mitigate metabolic liabilities, contributing to clinical study design regarding metabolite monitoring).
Team Leadership and Mentorship: Lead a team of skilled MetID scientists and manage group priorities and resources, ensuring high-quality and timely delivery of metabolite identification results across multiple programs. Mentor and develop scientific talent, provide performance feedback, and champion innovation and excellence in structural elucidation skills.
Data Interpretation and Reporting: Review and approve study reports and presentations, ensuring scientific conclusions about metabolite profiles are accurate and supported by data. Contribute to regulatory documents (INDs, NDAs) by reviewing sections on metabolite identification and metabolite safety assessments.