Associate Director Monitoring

Location
Tarrytown, New York
Posted
May 01, 2018
Ref
13213BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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:

The Associate Director Clinical Monitoring is responsible for building up and development of the Clinical Monitoring. The incumbent will be responsible for development and implementation of standards and best practices for effective clinical monitoring of investigational sites to ensure adherence to GCP and required regulations and to meet recruitment targets. In close collaboration with the appropriate individuals within the CPMO, responsible for the continuous process improvement for clinical monitoring. Responsible for managing staff and providing leadership to the staff of the Clinical Monitoring Unit.

Duties:

• Ensures adherence and compliance with all legal and regulatory requirements for the company
• Ensures that all administrative processes run properly
• Ensures that good communication channels are established within the Clinical Monitoring and with the clinical study teams for effective information and communication flow
• Ensures appropriate staffing and resource utilization of the clinical monitors and for the clinical trials
• Provides oversight of the work of the clinical monitors to ensure adherence to GCP and monitoring plans and performs co-monitoring or monitoring oversight visits as appropriate
• Provides input and supports the selection of appropriate trial sites in the US and Canada
• Has a comprehensive overview of the clinical projects, the main studies, the responsibilities and functions within the teams and the overall strategies within the projects and within the company.
• Maintains current scientific knowledge. Collaborates in the development, maintenance and adherence to SOPs and Working Instructions, standards and best practices to support effective clinical trial management, clinical trial assistance and clinical monitoring of investigational sites and continuous process improvements
• Oversees Company global processes to ensure their adherence to the local legal requirements and regulations
• Collaborates with the management of CTM and CCT in resolving systematic errors detected in audits
• May have direct supervisory responsibilities for CTM staff. Line management responsibilities including work assignments, performance management, professional development, recruiting, ongoing training, and study support/oversight.
• Accountable for objective setting and performance management of direct reports to ensure delivery of agreed upon objectives
• Identifies training needs for the department
Creates an environment that attracts, develops and retains high quality employee

Requirements:

• Demonstrated experience in drug development, including design and execution of global clinical development programs
• Experience in European, FDA and local regulations and ICH-GCP
• At least 5 years of leadership experience.
• Ability to mentor and develop people
• Profound experience in clinical trial management and clinical monitoring.
• Excellent problem solving and team building skills.
• Excellent management and leadership skills
Bachelor's degree and 8-10 years of relevant experience, 7 years experience in clinical monitoring.

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 Regeneron's 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.

Requisition Number: 13213BR