Assoc Director, Clinical Operations - NC Pharma (Top Dollar)

Our client, a premier specialty pharmaceutical firm headquartered in Research Triangle Park, North Carolina, is actively recruiting for an accomplished and impactful Clinical Operations leader to assume key role on its expanding Research & Development team.  The Company, which in-licenses later stage drugs and moves them thru the commercialization process, has several successful marketed products and many more in the pipeline.  The AD will drive all Clinical Operations.  Company seeks a seasoned professional who offers demonstrated success as both a strategist and a tactician. Company is experiencing significant growth.  Seek a leader who can build infrastructure, policy and procedure.

Specific responsibilities will include:



· Design, establish, and maintain an organizational structure and staffing to effectively accomplish Clinical Research and  organization's goals and objectives within the function.

· Drive the selection of vendors who lead the day-to-day clinical trials efforts.  Act as primary contact for the CROs and other vendors who participate in the conduct of all clinical trial activity.

· Manage the manpower utilization process for all clinical efforts.  Build a clinical operations team that promotes quality and collaboration.

· Contribute to the design, development, review and approval of clinical trial protocols, clinical trial reports, etc.

· Guarantee alignment with the supporting areas within R&D for resource optimization with timely implementation of clinical trials and publication of results. 

· Ensure that all activities are in compliance with ICH and other international regulatory guidelines and follow relevant GCPs and SOPs

 

Ideal candidate will offer 8+ years in Clinical Operations including 3+ years within leadership.  Some experience working directly for a pharmaceutical company will be important.

Impressive technical/scientific credentials must be complemented by excellent project management skills (including budget and timeline management), a strategic and results-oriented approach to drug development, proven ability to develop productive relationships with vendors, and sound operational judgment.  Company is flexible regarding therapeutic area.

Compensation package will include industry-leading base, bonus, stock, benefits and relocation package.  Please forward Word resume to leef@frankelstaffing.com