Scientific Associate Director, NBE DMPK Lead

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.Your RoleThe New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) Lead is a strategic, scientific, and operational role within Research and Development (R&D). Merck Healthcare is dedicated to delivering transformational medicines to patients, and in this role, you will collaborate within a matrixed environment alongside passionate functional experts to advance novel biotherapeutics.You will be responsible for overseeing the clinical bioanalytical work conducted by external partners, ensuring methodological robustness and compliance with regulatory requirements. Specifically, you will coordinate the validation of bioanalytical assays related to pharmacokinetics (PK) and immunogenicity assessments, and perform quality reviews of bioanalytical data and reports. Throughout the studies, you will provide troubleshooting support as needed.Additionally, you will serve as an NBE DMPK lead for clinical drug development, participating in cross-functional global teams responsible for bioanalytical strategies related to PK and immunogenicity. You will also support regulatory submissions by authoring relevant sections, including those for IND and BLA filings.Who You ArePh.D. in Biochemistry, Biology, Chemistry, or a related fieldSeveral years of experience in the pharmaceutical industry or CRO in comparable rolesPreferred QualificationsStrong experience with biological molecules such as NBEs, ADCs, and other novel modalitiesExtensive background in ligand-binding assays, with preference for experience in cell-based assaysExcellent understanding of bioanalytical strategies and scientific approaches for large moleculesIn-depth knowledge of GLP/GCP regulationsExperience supporting regulatory submissions, including authoring Integrated Summary of Immunogenicity, Clinical Study Reports (CSRs), summary sections for INDs, Investigator's Brochures (IBs), briefing books, and BLAsGeneral knowledge of disease areas such as Immunology and Oncology, along with an understanding of biology and pharmacologyExcellent organizational and communication skills, with fluency in spoken and written EnglishStrong intercultural awarenessMature leadership and influencing skillsWe are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that empowers everyone to work their magic and champion human progress.J-18808-Ljbffr