Clinical Development Manager

Novartis Animal Health is a world leader in the development of animal health products that meet the needs of pet owners, farmers and veterinarians. Our products are brought to life by diverse, talented, high-performing employees who are committed to saving, prolonging and improving animal lives.

At Novartis Animal Health, our focus is clear, our purpose defined.

Think What’s Possible.Leadership of or participation in the development of the efficacy part (Efficacy Compo-nent) of International New Product Development Projects. Leadership or membership of Efficacy Expert Teams (EET) to ensure efficient clinical development of new products with highly competitive profiles in an aggressive time to market within agreed budget and timelines. 1. Responsible and accountable for trial protocols, timelines, budgets, risk management, Investi-gator and site selection, case recruitment Study Monitor direction, data collection, final trial reports and quality. Works closely with counterparts in a matrix organization to obtain regula-tory approval of new animal health products.2. Leads Efficacy Expert Teams comprising Clinical Development Managers from various coun-tries, Technical Development specialist, safety specialist, regulatory specialist, Quality, etc.3. Ensures compliance of clinical development projects with external and internal quality re-quirements.4. Assumes global responsibility and accountability for the development of the efficacy part of the registration dossier according to specific requirements (FDA, EPA, USDA, EMEA, ANZ, JPN, etc).5. Develops and implements clinical development strategies to achieve objectives in optimal timeline and budget.6. Guides, overviews and assumes responsibility for all legal/contractual activities in the clinical development project in conjunction with IPL. 7. Evaluates, interprets and summarizes development activities and reports for regulatory agen-cies, corporate management and international development teams.8. Establishes and maintains relationships with institutional, government, regulatory agencies corporate and private authorities and experts in various fields to insure that all operating pro-cedures are in compliance with Good Laboratory Practices/Good Clinical Practice (GLP/GCP) regulations.9. Participates in professional organizations, remains current in research, data management technologies, pharmacology, medicine, biology/physiology, regulatory laws and emerging technology in animal medicine by interactions with leading scientists and regulatory authori-ties to maintain a competitive awareness.10. Provides support to evaluate new product projects offered through R&D and BD&L.Qualifications? Graduate degree in science (preferably biology, veterinary medicine, agronomy, chemistry, pharmacology, toxicology) or equivalent experience with contract research & product development.? 3-5 years of drug development experience.? Experience in leading complex international clinical development projects, preferably in Animal Health Industry.? Experience in Project Management and in the use of Project Management Tools.? Experience in leading international and multidisciplinary teams.? Knowledge of regulatory requirements, quality requirements and systems.? Advanced knowledge of drug development including study design and basic bio-statistics, pharmacology and formulations.BenefitsCompetitve benefits to include medical, dental, vision, 401K, LTD, STD and more.
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