Scientific Associate Director, NBE DMPK Lead
About The Position
The 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.
Requirements
- Ph.D. in Biochemistry, Biology, Chemistry, or a related field
- Several years of experience in the pharmaceutical industry or CRO in comparable roles
Nice To Haves
- Strong experience with biological molecules such as NBEs, ADCs, and other novel modalities
- Extensive background in ligand-binding assays, with preference for experience in cell-based assays
- Excellent understanding of bioanalytical strategies and scientific approaches for large molecules
- In-depth knowledge of GLP/GCP regulations
- Experience supporting regulatory submissions, including authoring Integrated Summary of Immunogenicity, Clinical Study Reports (CSRs), summary sections for INDs, Investigator’s Brochures (IBs), briefing books, and BLAs
- General knowledge of disease areas such as Immunology and Oncology, along with an understanding of biology and pharmacology
- Excellent organizational and communication skills, with fluency in spoken and written English
- Strong intercultural awareness
- Mature leadership and influencing skills
Responsibilities
- Overseeing the clinical bioanalytical work conducted by external partners, ensuring methodological robustness and compliance with regulatory requirements.
- Coordinating the validation of bioanalytical assays related to pharmacokinetics (PK) and immunogenicity assessments, and perform quality reviews of bioanalytical data and reports.
- Providing troubleshooting support as needed.
- Serving as an NBE DMPK lead for clinical drug development, participating in cross-functional global teams responsible for bioanalytical strategies related to PK and immunogenicity.
- Supporting regulatory submissions by authoring relevant sections, including those for IND and BLA filings.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
501-1,000 employees
