JOB DESCRIPTION:
Primary Job Function:
The Clinical Sciences Director heads the department, and provides strategic, scientific and managerial leadership to the Clinical Sciences Team.
Ensure that all clinical development work assigned to the Function ie Clinical Pharmacology and Bioanalytics department is carried out in a timely manner with the required quality standards.
Ensures scientific excellence and compliance with ethical and regulatory standards of all deliverables of the team ie Clinical Pharmacology and Bioanalytics (internal and external reports, publications, abstracts, posters, communication with Regulatory Authorities etc.) as a member of the Senior leadership of Clinical Development.
Stimulate creative thinking and encourage work/thinking (including publications) that may support the EPD goals.
The Director Clinical Science as a core member of Clinical development leadership Team sets strategic direction for Global and regional clinical development functions aligned with EPD Business objectives.
Participate in Strategic Teams and Project Team as applicable and provide pharmacokinetic expertise to the Project Teams, Product development team, Label Teams and Regulatory Affairs (RA) if needed.
Core Job Responsibilities:
Clinical Development Strategic and Leadership Activities
Serves as a core member of Clinical development leadership Team and helps in setting strategic direction for Global and regional clinical development functions aligned with EPD Business objectives.
Responsible for governance of all critical issues and non-conformances arising from clinical studies across various forums and if needed raise to I and D LT.
Responsible with other members for planning of departmental Budgets and oversight.
Responsible with other members for review of workload and planning of resources for department and strategies for efficiency aligned with EPD objectives.
Core member of clinical development leadership team to review TM for clinical development teams.
📌 Director Clinical Science (Mumbai)
🏢 Abbott
📍 Mumbai