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 Job #02594 Email this job to a friend
About our client
Our client is a human health care company seeking innovative solutions in disease prevention, cure and care for the health and well being of people worldwide.
Position Location
Senior Director of Clinical Operations New Jersey
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Manage, train and mentor a multifunctional clinical operations team consisting of approximately 60 staff members in the US
2) Oversee operational research activities across three major indications: oncology, CNS and internal medicine
3) Provide the technical expertise to lead the management of clinical trials across the Clinical Operations Group, including Finance and Clinical Supplies functions
4) Liaise with other functional departments within the organization, including global functions to ensure smooth development of priority projects in a timely manner
5) Maintain all programs in line with approved clinical development plans
6) Drive regional and global coordination
7) Liaise with EU colleagues to improve and integrate clinical operations processes across regions
8) Define and implement franchise projects and study team operating models globally
9) Integrate processes to improve the efficiency of drug development within the organization
10) Translate strategy and policies while providing supervision for all programs
11) Provide direction and supervision to the Clinical Operations Department which includes: therapeutically aligned directors and associate directors, RDDC and QC (within Clinical Operations) aspects of eDMS, Clinical Drug Supplies, and Clinical Operations Business Manager
12) Structure, set objectives and track process of Clinical Operations so that it aligns with the company's short- and long-term goals with respect to speed/efficiency, quality and customer satisfaction
13) Prepare and manage the departmental financial budget
14) Direct and/or facilitate the development and implementation of prioritized Global Clinical SOPs/SWPs
15) Manage and develop team of direct reports using appropriate formal and informal processes
16) Mentor individuals and ensure efficient allocation of resources within area of tasks
Requirements
1) Bachelor's degree in an associated scientific discipline/advance degree (MS) highly preferred
2) 15 – 20 years of relevant experience in the pharmaceutical industry especially in study management
3) Minimum 5 years of line management experience leading a similar group within the pharmaceutical industry
4) Pharmaceutical experience in NDAs, preparing for Advisory Board, Phase 1-2 studies preferred

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