Vice President, Clinical Operations

SUMMARY OF KEY

The principal  of this position are to provide strategic and managerial oversight of all clinical operations functions including Clinical Outsourcing, Clinical Project Management, Clinical Trial Materials Management, and Clinical Monitoring Management. This position will be responsible for organizing and implementing operational strategies for all development projects within Clinical Research and for those clinical programs requested by Medical Affairs at Sepracor. A major focus of the VP of Clinical Operations is to align objectives and resources across all clinical operation functions, in particular assuring that resources allocated to a given functional group match the workload priorities. In this context, close control of the Clinical Outsourcing function is essential to effectively utilize external CROs and other support services, and thereby minimize the need for additional internal head count, as Sepracor continues to expand its clinical research activities globally. In addition, this position will monitor the production of regulatory documents generated within Clinical Research, in collaboration with the Regulatory Affairs and Biometrics and Data Management departments. The Vice President Clinical Operations is expected to supervise and mentor the current leaders of these key operational groups within Clinical Research and is an integral member of the Senior Management Team at Sepracor.

ESSENTIAL FUNCTIONS REQUIRED FOR JOB

The essential functions for the Vice President Clinical Operations are to guide and integrate the operational activities at Sepracor to their optimal use and to work closely with other members of the senior management team to achieve the strategic goals set for Clinical Research and Medical Affairs. The individual operational groups reporting to this position are briefly characterized here:

1. Clinical Outsourcing
The incumbent will supervise the head of of the Clinical Outsourcing group and, in collaboration with other drug development functions, determine policy and strategic planning that pertains to the outsourcing of clinical trials.

2. Clinical Project Management (CPM)
The incumbent will supervise the head of Clinical Project Management and participate in overall product development planning process and be involved project level budget planning and review.

3. Clinical Trial Materials Management (CTMM)
The incumbent will supervise the head of Clinical Trial Materials who is responsible to lead forecasting of drug product needs for clinical trials and capacity planning

4. Clinical Monitoring Management (CMM)
The incumbent will supervise the head of Clinical Monitoring Management and determine policy and strategic planning that pertains to clinical monitoring within clinical operations.

Drive compliance standards and operational excellence through our Clinical Processes to ensure efficient and high quality Clinical Trials.

Work with Clinical Operations leadership to build external alliances, collaborate with domestic and international government agencies (e.g. FDA), and leverage internal and external relationship to provide skills and resources to Clinical projects in a thorough and responsible manner.
Experience required 10+ Years
Experience and other requirements KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

Education: Bachelor’s Degree and advanced degree in business, health, or life sciences required.

Experience: The applicant for this position should be qualified by 15+ years of pharmaceutical industry or other applicable experience, depending on educational level. Direct experience in clinical operations management involving outsourcing of clinical trial work to contract research organizations is a requirement.

Complexity: The selected individual must be a self-starter, highly motivated, independent and innovative. The ability to recognize problems as they develop, excellent interpersonal skills and the ability to function as a leader and mentor are required. Overall, the clinical trial arena is a time-sensitive, high-profile area of work at Sepracor where considerable company resources are expended in support of the business plan. A successful candidate must be qualified by education, training, and experience to excel in the assignment.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters while working at Sepracor is considered confidential.

Mental/Physical Requirements: The position incorporates a mix of  (multiple projects, staff supervision, regulatory compliance, etc.) in a time-sensitive area of work. Therefore, the position requires a resilient individual able to work independently, with initiative, while exercising excellent judgment and compliance to internal SOPs and regulatory requirements. Outstanding written and oral communication skills are required as is the ability to communicate appropriate material in a timely manner up, down, and across the organization. Requires ability to use a personal computer for extended periods of time and BlackBerry or similar device to maintain contact when traveling. This position requires domestics and international travel

Additional Requirements: Work hours may include meetings scheduled outside of normal working hours. Demands during peak times may require work hours outside of normal working hours. Business travel is a component of the position.

THIS DESCRIPTION IS NOT INTENDED TO BE A COMPLETE STATEMENT OF JOB CONTENT, RATHER TO ACT AS A GUIDE TO THE ESSENTIAL FUNCTIONS PERFORMED. MANAGEMENT RETAINS THE DISCRETION TO ADD OR CHANGE THE DUTIES OF THE POSITION AT ANY TIME.
Minimum education requirements Masters