Associate Director Operational Study Optimization
The Associate Dir, Operational Study Optimization will lead a range of operational study optimization activities to generate operational insights in partnership with Regeneron study teams. These insights will inform the strategic development of Clinical Study Concepts, Study Protocols and Operational Plans that will enable predictable delivery of clinical programs and studies. Responsible for driving the consistency and governance of our processes through close collaboration with our internal stakeholders this role ensures the delivery of cross functional operational input into early budget and baseline development. They will be key in developing an external relationship platform with vendors and experts to facilitate a wide source of country and disease area intelligence that can be utilized in study design and operational planning.
• Oversight of feasibility process execution to ensure the generation of high quality and timely data to inform study design, optimal geographical study placement and operational planning.
• Provide strategic input into the development and implementation of the Study Optimization function through leading process initiatives and change management activities.
• In partnership with Data and Analytics, will inform data sourcing and utilization strategy to enable a variety of data options to be available that aligns with portfolio strategy
• Partner with Clinical Outsourcing in the identification, qualification and effective relationship management of a range of high quality vendors that can be utilized in study optimization processes
• Partner with study teams on complex or high priority engagements to articulate the data story based on feasibility and centrally derived data to support decisions to enhance protocol design
• Portfolio level coordination of Study Optimization engagements to support resource planning and functional management of the team.
• Partner with teams on complex or high priority CRO led feasibility activities to enable validation of study and country level enrolment rates and study start up timelines to inform budget and baseline setting.
• Drive the consistency and governance of study optimization processes through leadership of continuous improvement activities and the development and delivery of training.
• Lead activities to obtain, analyze and deliver high quality targeted information from external stakeholders to inform study design and operational planning decisions.
• Lead activities to generate and deliver patient insights as required to teams to inform study design and operational planning.
• Partner with study teams to develop and implement effective patient recruitment and retention strategies and tactics.
• Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
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.
Qualified candidate will have a BS in a related discipline; A MS or MBA is highly desirable.
At least 7 years of relevant industry experience within pharma/biotech, a CRO or consulting is required, with 2 years of functional leadership highly desirable.
• Extensive experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval
• Compelling communicator with ability to translate complex messages to a variety of audiences.
• Proven ability to lead teams and build strong working relationships in a diverse range of environments
• Extensive knowledge of clinical trial intelligence data and vendors as well as experience in utilizing data to inform clinical strategy development
• Ability to understand complex business questions and develop effective solutions
• Experience in leading process development, implementation and change management activities
• Thrives in a highly dynamic environment where creativity is key in meeting the needs of key stakeholders
• Self - motivated , good interpersonal and leadership skills, a team player
• People management experience required.
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.
LMR, Program Management, operational program strategy, operational feasibility, clinical trial analytics, study level planning, Oversight of clinical monitoring, Clinical Operations, Clinical Research Manager,
Clinical Study Optimization, Clinical Trial Quality, Optimization Manager Clinical Trial Effectiveness