Sr. Manager Clinical Affairs

DUTIES AND RESPONSIBILITIES

GENERAL PURPOSE OF THE POSITION - This position, which reports to the Director of Clinical Affairs, is responsible for overseeing 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. Responsible for oversight of clinical affairs functions on all phases of clinical studies conducted under an Investigational New Drug (IND) application. Designs, develops, establishes and approves methods and processes for the implementation of clinical protocols and conduct of clinical studies according to Good Clinical Practices. Oversees analyses and presentation of clinical trial results to effect product approval and marketing applications.

* ESSENTIAL FUNCTIONS AND RESPONSIBILITES -Oversees Clinical Affairs activities for project(s) including, but not limited to, the following:
* Evaluation, selection and management of CROs and other contract vendors. Acts as primary point of contact with CROs on major projects.
* 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 Practice and appropriate federal, state and local requirements. Conducts or oversees audits of CRO performance.
* Review, evaluation, analysis, reporting and presentation of moderate to highly complex clinical data.
* Oversees, manages and approves interactions with internal product development teams and Contract Research Organizations (CROs) related to the planning and development of clinical research projects and conduct of clinical trials.
* Maintains up to date, in-depth operational knowledge of Good Clinical Practices, regulatory guidances and industry best practices. Advises management of key developments and their implications to Dey. Makes recommendations regarding process and practice modifications based on research. Implements approved recommendations.
* Maintains strong overall medical/scientific knowledge about therapeutic areas of focus for clinical development project(s) and establishes collaborative relationships with medical/clinical experts.
* Oversees clinical input for meetings with the FDA (including Pre-IND, End-of-Phase II, etc.). May represent Dey at meetings with the FDA.
* Oversees the planning, writing and/or review of and provides initial approval of clinical input into regulatory submissions to FDA including INDs, NDAs, Annual Reports, Pre-meeting Packages, etc. for clinical development project(s).
* Oversees Clinical Affairs involvement and input into the writing, of clinical protocols, Investigator Brochures, Clinical Study Reports and other clinical documents such that documents are written to the level of sophistication required to meet project and company objectives. Provides initial approval for release of documents.
* Advises and proposes appropriate actions to key management regarding potential implications of clinical trial progress/results. Oversees implementation of approved modifications to study plans. Provides leadership in resolving issues.
* Oversees preparation and/or review of written and delivery of oral presentations to management regarding clinical trial progress/results. Recommends mid course corrections as needed.
* Leads or functions as a member of development project teams and maintains close working contacts with medical affairs, clinical sciences, business development, sales and marketing.
* Functions as mentor and designs and implements development plans for lower level Clinical Affairs personnel.

REQUIRED EDUCATION/EXPERIENCE/SKILLS

Requires a PhD or equivalent in a scientific or nursing discipline, at least 10 years of directly related experience including a minimum of 5 years supervisory or management experience. Must have significant experience in managing multiple projects.

DEY supports diversity in the work place. We are an Equal Opportunity Employer.