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Senior Manager Global Trial Optimization

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Aug 10, 2022
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Job Details

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 authorities to facilitate a wide source of country and disease area intelligence that can be applied in study design and operational planning.

A typical day may include the following

  • 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 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 activities to generate and deliver patient level insights as required to teams to inform study design and operational planning.
  • 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.
  • Create and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
  • May require up to 25% travel

To be considered

  • BS in a related field and a minimum 7 years of relevant industry experience within pharma/biotech, a CRO or consulting is required
  • Solid 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
  • Experience in process development, implementation  and change management activities
  • 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 eligible 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 parental 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.

Development Operations - #GDDOPMJobs

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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