The Associate Director, Clinical Bioanalysis, will be responsible and accountable for executing clinical bioanalytical strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, managing outsourcing efforts, and collaborating with cross-functional stakeholders including clinical pharmacology, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, clinical QA, finance, and legal. This position will report to the Director, Clinical Bioanalysis, and work on-site at our Waltham, MA office.What You’ll Do:Develop and implement bioanalytical strategy for compounds from first-in-human to later phases of clinical development (phase 2 and 3 studies and NDA/MAA submissions) to ensure timely, quality, and compliant delivery of clinical bioanalytical support.Represent the department as bioanalytical subject matter expert on cross-functional study teams and manage and resolve problems or issues relevant to clinical bioanalysis.Provide scientific and technical oversight to the bioanalytical vendors on method development/validation/transfer, and sample analysis.Review bioanalytical contracts, review bioanalytical study plans and data, provide data transfer agreements, review and approve method validation and bioanalytical reports and ensure their regulatory compliance.Identify, evaluate, and select vendors to support quantitative bioanalysis of clinical study samples in a regulated (GLP, GCLP) environment.Participate in regular vendor meetings, build and maintain positive relationships with external vendors.Ensure delivery of clinical bioanalysis data and reports with high quality according to timelines.Collaborate with colleagues within the department, internal stake holders (i.e., data management, clinical operations, CMC, clinical QA, procurement, legal, regulatory, etc.).Contribute to the preparation and review of relevant sections of clinical and regulatory documents and response to queries from regulatory agency on clinical bioanalysis.Contribute to optimizing and improving the operational performance, quality, and productivity of the function.
