Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post : Associate Director - Global Preclinical Development, EPD
Job Description
The Position
Assist Senior Management in leading the EPD Preclinical Development function by providing preclinical input to Toxicologists in the Global Preclinical Development (GPD) Team, manage and direct as needed toxicology Project and EPD Development.
Expected non-clinical development support through the design, management and regulatory requirements of specific non-clinical safety projects for the company's drug development programs, as well as provide expertise and guidance in Scientific, Regulatory & Innovation Toxicology to project teams as needed.
Highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. Adhere to established processes, policies, and quality systems for outsourcing, managing and reporting regulatory toxicology programs, studies, and other activities.
Core Job Responsibilities :
• Responsible for the performance and quality of preclinical work and deliverables, e.g. nonclinical safety and risk assessments related to EPD products as well as preclinical contributions to regulatory submissions (dossiers, variations).
• Contributes via global project teams to oversight and guidance in the design, conduct, and supervision of pre-clinical toxicology studies in accordance with rules and regulations.
• Responsible for chairing the Abbott Drug Handling Committee (ADHC), review GPD team member preparation and maintenance of Employee Exposure Limits and Residual Dose Limits for EPD products and its intermediates, to ensure occupational and product safety.
• Establish effective working relationships with cross functional team members to ensure all toxicology studies are completed with high quality in a timely, and scientific manner.
• Contribution to the preparation of regulatory documents interactions with regulatory authorities as needed. Lead operational activities as appropriate. Interface with Senior Management to provide and obtain information and to build consensus regarding project direction. Active participant on global project/program teams and work closely with other functional area.
Position Accountability / Scope:
• Accountable for planning and developing nonclinical activities (toxicology) and will provide guidance in nonclinical development to project/program team members.
• Conversant with tools for insilico analysis, organizing & monitoring of in vivo toxicology studies, able to review and approve final study reports, and communicate with Senior Management and external stakeholders.
• Essentially, the candidate needs to offer support by managing the team, attend day-to-day tasks, peer review the risk assessment reports and take the responsibility of developing the excellent centers of DMPK & in-silico analysis.
• Potential to manage direct reports in toxicology.
Candidate Profile
• Ph.D in Pharmacology / Toxicology, or equivalent with a broad medical knowledge required for participation in internal safety Committees. DABT certification would be a plus.
• Broad and deep understanding of the drug development process and its preclinical disciplines (pharmacology, DMPK, toxicology), people management, organizational and business awareness, strategic thinking.
• Past leader of a function and 10 or more years of experience in the Pharmaceutical Industry
Additional Information
Qualification : Ph.D
Location : Mumbai
Experience : 5+ years
Industry Type : Pharma/ Healthcare/ Clinical research
Department : Regulatory Affairs
Job id : 30949719
End Date : 10th April, 2020
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