Executive Director and Head of Clinical Trial Management

Recruiter
Regeneron
Location
Tarrytown
Salary
Competitive
Posted
Jul 17, 2017
Closes
Jul 19, 2017
Industry
Education
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Provides overall strategy, direction and leadership for clinical trial management and Clinical monitoring activities for staff in Tarrytown, Basking Ridge and Dublin offices. Incumbent is responsible for oversight and leading clinical trial managers and clinical monitoring staff in the successful conduct of multiple clinical trials. Ensures effective administrative management of clinical trial operations related to personnel and policy in order to provide quality study patient care, education, and research within the programs fiscal plan. Oversees and monitors specific aspects of clinical studies utilizing both traditional and centralized monitoring methods, i.e., compliance with regulatory requirements, vendor oversight, risk management, financial management, drug distribution, document management, and SOP training.

Essential Duties and Responsibilities:

The primary responsibility is to provide oversight and direction for the successful conduct of all clinical trials conducted by CD&RA. The incumbent will oversee operational planning and execution to ensure all trials are completed on time, are of high quality, within budget, and with sufficient oversight of vendors and internal personnel to assure the integrity of data from these trials.
Additionally, either directly or with the assistance of subordinate managers, the incumbent will:
  • Assure that policies and procedures are in place to:
o Design, budget, resource, implement, conduct, and complete clinical studies adherent to all applicable regulations, ethics requirements, and Regeneron quality standards
o Identify, engage, and manage vendors to assure proper completion of work contracted
o Monitor and effectively manage internal personnel in the management and oversight of clinical trials
o Provide oversight of vendors in the conduct of clinical trials
o Assure proper lines of escalation exist to resolve problems expeditiously
o Assure adequate risk identification, mitigation, and management plans exist for all clinical trials
o Assess the capabilities of clinical trial managers to complete their duties

  • Assure the following:

o All Clinical Trial Managers and other personnel in the CTM organization have the skill sets necessary to complete their assigned tasks
o That clinical trials are properly budgeted and resourced, properly conducted, and adequately monitored via on site staff or via CROs
o That relevant information regarding clinical trials (e.g., protocol deviations, investigators contacts, audit findings) be collected, documented, and acted upon appropriately. This documentation should be standardized across all clinical trials.
Knowledge and Specialized Skills:
  • Thorough knowledge of clinical trial conduct both in the United States and Internationally
  • Proficiency applying relevant federal regulations and international regulations related to clinical trial management
  • Full knowledge and experience regarding the management and oversight of external vendors (e.g., Contract Research Organizations).
General Skills:
  • Effective communications skills (verbal and written)
  • Managerial competence
  • Proven leadership capabilities
  • Forward thinking; ability to plan and drive for results
  • Strong Business acumen
Education and Experience:
A Bachelors degree (BS or BA) from an accredited college or university plus twelve (10) or more years of experience and five (5) years of management experience is required. A demonstration of increasing levels of responsibility. A higher degree such as PhD, Pharm D or Masters degree is preferred.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.