Senior Manager, Global Trial Optimization - Feasibility

The Senior Manager, Global Trial Optimization (GTO) will lead program or study level activities to advise 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 used in study design and operational planning.

• Lead study level feasibility processes to generate high quality and timely data to inform study design, efficient geographical placement and operational planning.
• Partner with teams during CRO led feasibility activities to support validation of study and country level enrollment rates and study start up timelines to advise 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 country level feasibility and centrally derived data to support data driven decisions to improve 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 acquire, analyze and deliver high quality targeted information from external partners to advise study design and operational planning decisions.
• Lead study level activities to generate and deliver patient level insights as the need arises to teams to advise study design and operational planning.
• Prove input into 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 used in Global Trial Optimization processes
• 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
• May require up to 25% travel

Requirements:

Bachelor's degree in a related field; At least 7 years of relevant industry experience within pharma/biotech, a CRO or consulting is required

• 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 sophisticated messages to a variety of audiences.
• Confirmed ability to build strong working relationships in a diverse range of team environments
• Experience in using data to inform clinical strategy development
• Ability to understand sophisticated business questions and develop effective solutions
• Experience in process development, implementation and change management activities
• Thrives in a highly multifaceted environment where creativity is key in meeting the needs of key team members
• Self - motivated, good interpersonal and leadership skills, a teammate
• Line management experience preferred

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.