Regeneron Pharmaceuticals Director Program Operations Leader - Early Clinical Development in Tarrytown, New York
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.
The Program Operations Leader (POL), Early Clinical Development is responsible for leadership and overall strategic management of one or more complex programs in 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 regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring and performance management.
• Responsible for the overall success of the clinical study team(s) within a program(s) in Early Clinical Development
• Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested
• Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Oversees clinical study timelines within a clinical program(s)
• Provides input and operational insight into Clinical Study Concepts (CSC)
• Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM
• Oversees clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
• Ensures timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
• Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
• Acts as point of contact for clinical program and study level escalation
• Reviews key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
• Provides proactive creation and implementation of risk 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
• Drives the strategy and oversight for vendor selection and management within a clinical program(s)
• Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts
• Identifies and recommends changes to practices and policies, including initiating and participating in
strategic projects, initiatives, and continuous improvement projects within Global Development
• Attends and represents CTM for a program(s) at review committee meetings as appropriate
• Participates in CRO governance meetings as needed for clinical program(s)
• Participates in Joint Meetings with Collaborative Partners at the study level and program level
• Ensures inspection readiness throughout the clinical program lifecycle and is the cross functional leader for Regulatory Authority Inspections
• Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs
• Responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
Key Team Membership:
• CTM Leadership Team
• Vendor Governance Committee(s)
• Clinical Operations Review Meeting(s)
• Development Team(s)
• Clinical Compliance Meeting(s)
• Strategy Review Meeting(s)
Cross Functional Interfaces
• Interface with key clinical and regulatory functional area leads
• Project Management
• Medical Director(s)
• Clinical Finance
• Strong interpersonal & leadership skills
• Ability to provide strategic direction and guidance for clinical programs
• An understanding of relevant industry trends
• Analytical skills with a data driven approach to planning, executing, and problem solving
• Effective communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate
• Budget management experience
• Ability to build productive teams and collaborations
• Strong project management, cross-functional team leadership and organizational skills
• Demonstrated vendor management experience
• Line management experience with demonstrated mentoring and coaching skills
• Extensive experience in global clinical trial operations
• A working knowledge of GCP and ICH
Bachelor’s degree and minimum of 12 years relevant industry experience, 8 years within the function. Advanced degrees may be considered in lieu of relevant experience
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.