Sr Mgr Global Trial Optimization

Regeneron Pharmaceuticals

4d

About The Position

The Senior Manager, Global Trial Optimization will lead program or study level activities advising on our clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies. You will develop and maintain relationships with our external experts facilitating a wide source of country and disease area intelligence used in study design and operational planning. A typical day may include the following: • 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 supporting 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. • Partner with Data and Analytics function to review and identify appropriate central data sources. • 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 for 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. • Prove input into continuous improvement activities to ensure consistency of process execution. • In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors. • 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 20% travel To be considered a Bachelors degree in a related field with a minimum of 8 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. Experience with feasibility. Must be a compelling communicator with ability to translate sophisticated messages to a variety of audiences.

Requirements

• Bachelors degree in a related field with a minimum of 8 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.
• Experience with feasibility.
• Must be a compelling communicator with ability to translate sophisticated messages to a variety of audiences.
• 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

Nice To Haves

• Line management experience preferred

Responsibilities

• 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 supporting 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.
• Partner with Data and Analytics function to review and identify appropriate central data sources.
• 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 for 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.
• Prove input into continuous improvement activities to ensure consistency of process execution.
• In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors.
• 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

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level