01Responsibilities
Formulate comprehensive clinical development plans for each new product. Build effective relationships within and outside Research and Development (Portfolio and Project Leadership, Regulatory Affairs and Pharmacovigilance, Clinical Development Sciences (CDS), R&D; Quality Assurance, Marketing, Manufacturing and Quality) during development of products and life cycle management to assure that all parties involved meet critical deadlines and deliver work with appropriate quality attributes (GCP, GLP). Specific duties include executing individual clinical programs. In cooperation with other teams (i.e. CDS, Biostatistics, Regulatory Affairs), design and write protocols for laboratory and field efficacy studies and TAS to generate information that will lead to regulatory approval of products. Work cooperatively with CDS to select suitable research facilities and qualified researchers to execute protocols. Coordinate with other teams to ensure study monitoring according to current applicable regulations, company policies, and management expectations. With support from other teams (i.e. Data Management, Medical Writing, Biostatistics, and internal / external SME reviewers), analyze and interpret results and author study reports. Work collaboratively with Regulatory Affairs to prepare reports and data for submission to regulatory agencies and present data to regulatory authorities and/or scientific meetings. Ensure quality assurance/regulatory compliance and participate and/or lead administrative and procedural activities such as development of new processes and / or functional procedures. Attend scientific meetings, continuing education courses and keep abreast of scientific advances and new developments in the animal health industry and veterinary profession.
What You Need to Succeed (minimum qualifications):
Education:
A DVM or a Ph.D. in an animal health related field is preferred. An MS with experience will be considered.
Experience:
A minimum of 5 years of experience in product development within or closely associated with the pharmaceutical industry is preferred. Outstanding organization, motivation and communication: ability to organize and manage a variety of projects at any one time demonstrating strict attention to detail; self-motivated and able to work and learn without direct supervision. Current knowledge of all pertinent global / national / federal regulations under which therapeutic products are evaluated.
What will give you a competitive edge (preferred qualifications):
Basic understanding of research and development processes. Acting as strategist and facilitator to drive clinical programs. Good understanding and working knowledge of GCP/GLP/GMP and quality; proven experience working with regulatory authorities. Demonstrated ability to work with external partners. Experience and displayed achievements within the key competencies of .
