Head of DMPK
Adagene Inc. is looking for an energetic and talented individual to join its multidisciplinary research and development team. The Head of DMPK will collaborate cross-functionally to provide guidance on optimization and evaluation of DMPK properties for drug candidates and will be responsible for clinical pharmacology for our early phase clinical trials.
· Provide scientific guidance on lead optimization of programs and work in close collaboration with biology, non-clinical and clinical colleagues to optimize and evaluate the DMPK properties of candidate drugs.
· Serve on Discovery-stage project teams as a subject matter authority for PK/PD providing related input to define appropriate studies/endpoints and design of DMPK and PK/PD studies.
· Ensure complete preclinical DMPK assessment for clinical-stage candidate molecules and responsible for assembling IND enabling preclinical PK, PK/PD modeling and ADME packages.
· Provide strategic direction to the writing and review of clinical protocols, clinical study reports and Clinical Pharmacology documents, meeting background packages, and other documents submitted to regulatory authorities. Represent Adagene to discuss/defend data in front of FDA/CDE.
· Proactively communicating project team inquiries, requests, and expectations from the Project Teams to team members and management.
· PhD with 10+ years of extensive training and industry experience in bioanalysis, metabolism and pharmacokinetics supporting drug discovery and early phase clinical trials.
· A strong background in ADME and pharmacokinetics/pharmacodynamics as applied in antibody drug lead optimization.
· Hands-on experience in all aspects of PK study conduct, including study design, execution, interpretation and reporting, with proficiency in PK analysis required. Expertise in large molecules is preferred.
· Expert knowledge in pharmacokinetics, immunogenicity, drug-drug interactions, bioavailability/bioequivalence, special populations, and dose selection.
· Maintaining current knowledge of relevant scientific literature including regulatory guidance and standard methodologies as they pertain to DMPK, PK/PD, and clinical pharmacology.
· Highly effective organizational skills and detail-oriented with the ability to understand, plan, and navigate in a matrixed environment.
· Strong interpersonal and communication skills including exceptional collaboration and relationship management skills.