The Associate Director of Bioanalysis will be responsible for managing the design, analysis, interpretation, transfer and reporting of the bioanalysis of pharmacokinetic data from preclinical and clinical studies in utilizing state-of-the-art methodologies, working closely with both internal and external parties. Additional responsibilities include assisting in preparing and reviewing bioanalytical plans, protocols and reports to meet regulatory requirements and management of bioanalytical activities (budgeting, auditing CROs, setting up agreements etc).
- Assist in the development of BA strategy to meet current analytic needs by managing the implementation of bioanalytical contracts/SOW, plans, and reports to ensure that the BA data meet current/future regulatory and scientific requirements.
- Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness.
- Assist with the coordination of all bioanalysis activities for individual preclinical/clinical programs to ensure alignment of BA data deliverables.
- When necessary, participate in day-to-day operation of BA work, including the analysis of samples and associated duties, processing of biological samples, ensure adequate levels of reference materials, control matrix, and project-specific consumables and resources, assist in method validation, and data processing/reporting, QC checking and data compilation, and basic operation and routine maintenance of laboratory equipment
- Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies and safety procedures.
- Other duties as periodically assigned
- PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related disciple with considerable relevant industry experience required
- Good understanding of bioanalytical technology/methods both for small and large molecules required
- Excellent organization skills and be highly regarded in the in BA/PK area with a strong background with managing external CRO’s
- Well-grounded experience in drug development concepts – data driven decision making, functioning of project teams/sub-teams, development of protocols, clinical study reports etc.
- Ability to work in a dynamic team-oriented environment as demonstrated by participating in and contributing to cross functional teams
To apply, please send resume to firstname.lastname@example.org