Head Clinical Experimental Science & Observational Research

Location
Tarrytown, NY, United States
Posted
Jun 28, 2019
Ref
14993BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based bio pharmaceutical 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.

The Head, Clinical Experimental Science (CES) & Observational Research is responsible for leadership and overall strategic management of clinical research trials spanning the early development experimental science portfolio (e.g. biomarker development studies, platform validation studies, technology/innovation pilots, sample collection studies) and late development observational (non-interventional) research portfolio (e.g., post-authorization safety studies (PASS), evaluation of REMS and risk minimization measures, regulatory agency required non-interventional efficacy studies (e.g. PAES)) within Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP/GPP regulations and company Standard Operating Procedures (SOPs). The Head CES & Observational Research interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical trials and department initiatives. They are responsible for line management of clinical trial management staff (e.g. Clinical Study Leads), including responsibility for staff recruitment, development, coaching, mentoring and performance management.

Job Duties:
  • Responsible for the overall success of CES & Observational Research portfolio delivery and is the primary point of contact of leadership and oversight for the CES & Observational Research clinical trial management group


  • Responsible for providing direction, strategy and organizational development for the CES & Observational Research team


  • Drives strategic decision making and integrates all operational considerations for studies to ensure goals are attainable prior to implementation


  • Responsible for standard operating procedure development, maintenance and continuous improvement for CES & Observational Research


  • Drives the strategy for CRO/vendor identification & selection as well as relationship management


  • Maintains an overview of clinical trial(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provides updates to stakeholders, including senior management, as requested


  • Provides operational guidance and input into study synopses, protocols, feasibility, timeline and cost estimates during study development


  • Oversees clinical study budgets: ensures review, presentation and approval of initial study budget and manages the budget and escalates concerns to Therapeutic Area Operations Leader, as appropriate


  • Ensures timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across projects


  • Reviews key metrics and Key Performance Indicators (KPIs) across studies within CES & Observational Research portfolio to identify trends and create mitigation strategies


  • Provides innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges


  • Participates in review committee meetings, governance meetings, joint meetings with collaborative partners as needed


  • Responsible for resource forecasting and resource allocation for assigned portfolio
  • Responsible for direct supervision of staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.


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.