Temp - Senior Manager, Global Trial Optimization
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 Senior Manager, Global Trial Optimization (GTO) will lead program or study level activities to inform the clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies.. They will play a key role in developing and maintaining relationships with external experts to facilitate a wide source of country and disease area intelligence that can be utilized in study design and operational planning.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
• Lead study level feasibility processes to generate high quality and timely data to inform study design, optimal geographical placement and operational planning.
• Partner with teams during CRO led feasibility activities to support validation of study and country level enrolment rates and study start up timelines to inform budget and baseline setting.
• Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management activities.
• Partner with Data and Analytics function to review and identify appropriate central data sources and work with study teams to define assumptions for data curation and insight development
• Articulate the data story to teams based on based on country level feasibility and centrally derived data to support data driven decisions to enhance protocol design
• Project management of study level country landscape assessment activities and the collection of targeted feasibility information to support early assessment of operational feasibility for conducting clinical trials.
• Lead study level engagements to obtain, analyze and deliver high quality targeted information from external stakeholders to inform study design and operational planning decisions.
• Lead study level activities to generate and deliver patient level insights as required to teams to inform study design and operational planning.
• Prove input into a range of continuous improvement activities to ensure consistency of Global Trial Optimization process execution.
• In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors utilized in Global Trial Optimization processes
• Partner with study teams to develop and implement patient recruitment and retention tactics aligned with defined study strategy.
• Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
• Strong understanding and 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 build strong working relationships in a diverse range of team environments
• Experience in utilizing data to inform clinical strategy development
• Ability to understand complex business questions and develop effective solutions
• Experience in 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
• Line management experience preferred
Qualified candidate will have a BS in a related discipline; A MS or MBA is highly desirable.
At least 10 years of relevant industry experience within pharma/biotech, a CRO or consulting is required, with 2 years of functional leadership highly desirable.
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.
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