FierceBiotech and FiercePharma Jobs
Senior Manager - Clinical Affairs - Dey L.P
Jun 12
Location: Basking Ridge, New JerseyCategories: Administrative
Website: http://www.dey.com
Position Description
Essential Duties & Responsibilities
Reporting to the Director, Clinical Affairs, this position is responsible for oversight of the planning, design, development and implementation of strategies, plans and practices for diverse clinical projects within the clinical research program at Dey to ensure the approval of new products. The incumbent will oversee clinical affairs functions on all phases of clinical studies conducted under an Investigational New Drug (IND) application. This position designs, develops, establishes and approves methods and processes for the implementation of clinical protocols and conduct of clinical studies according to Good Clinical Practices and oversees analyses and presentation of clinical trial results to effect product approval and marketing applications.
Other Duties & Responsibilities
Evaluation, selection and management of Contract Research Organizations (CROs) and other contract vendors
Negotiating, evaluating and providing initial approval of legal and financial documents, e.g. contracts, budget proposals, confidentiality and indemnification agreements, insurance, etc.
Assuring clinical studies are conducted by the CRO in compliance with the protocol, Good Clinical Practices, and appropriate federal, state and local requirements, conducting or overseeing audits of CRO performance;
Review, evaluation, analysis, reporting and presentation of moderate to highly complex clinical data
Overseeing, managing and approving interactions with internal product development teams and (CROs) related to the planning and development of clinical research projects and conduct of clinical trials.
Education/Experience/Skills
The successful candidate in this role will have a PhD or equivalent in a scientific or nursing discipline with at least ten years of directly related experience, including a minimum of five years supervisory or management experience. The successful candidate must have significant experience in managing multiple projects.
