About This Role
This role involves providing strategic and scientific oversight for outsourced bioanalytical activities within clinical development programs, with a primary focus on pharmacokinetics (PK) and biomarkers. The Associate Director will manage external laboratory partners, collaborate with cross-functional stakeholders, and drive process improvements and the evaluation of emerging analytical technologies. The position suits a scientifically driven professional with deep expertise in bioanalytical sciences and a strong understanding of global regulatory requirements.
Responsibilities
- Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs
- Oversee bioanalytical method development, qualification, validation, and sample analysis activities, including scientific troubleshooting and optimization
- Develop and maintain strong partnerships with bioanalytical CROs and other external vendors to ensure successful execution of bioanalytical strategies
- Monitor vendor performance and ensure adherence to study timelines, quality standards, contractual obligations, and regulatory requirements
- Ensure bioanalytical activities are conducted and documented in accordance with applicable global regulatory guidance and industry best practices
- Serve as the bioanalytical subject matter expert on cross-functional project teams, providing scientific recommendations and risk assessments to support decision making
- Support regulatory submissions by contributing to and reviewing submission-related documents, responses to agency questions, and inspection-readiness activities
- Identify and evaluate emerging analytical technologies, biomarker strategies, and innovative measurement approaches that may enhance clinical development programs
- Drive continuous improvement initiatives and champion new technologies, digital solutions, and operational efficiencies within the bioanalysis function
Requirements
- Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or M.S. or B.S. degree with a minimum of 8 years of relevant industry experience
- Demonstrated expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic and biomarker assays
- Strong expertise in mass spectrometry-based assays, ligand-binding assays (LBA), and cell-based methodologies
- Strong understanding of global bioanalytical regulatory requirements
- Proactive problem solver with strong scientific judgment
- Excellent communication skills
- Ability to manage multiple projects simultaneously in a fast-paced environment
Important Details
- Work format: Remote or Full-time
