Associate Director, Global Trial Optimization

Location
Tarrytown, NY, United States
Posted
Jan 12, 2021
Ref
22846BR
Required Education
Bachelors Degree
Position Type
Full time

The Associate Director of Global Trial Optimization (GTO) will lead diverse operational study optimization activities to generate insights in partnership with Regeneron study teams. These insights will drive the clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies.

In this role, a typical day might include:

  • Leading study level feasibility processes to generate high quality and timely data to inform design, efficient geographical placement and study planning.
  • Providing strategic input and supporting the development and implementation of Global Trial Management through process initiatives and re-design.
  • Accounting for data generation, data analysis and interpretation.
  • Playing a key role in developing evidence generation strategy and execution of post registrational studies, including interventional and observational research.
  • Working with Clinical Outsourcing in the identification, qualification and relationship management of a range of high quality vendors that can be utilized in study optimization processes.
  • Collaborating 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 improve protocol design.
  • Leading portfolio level coordination of GTO team engagements to support resource planning and management of the team.
  • Working with partners on high priority CRO led feasibility activities to enable validation of study and country level enrollment rates and study start up timelines to guide budget and baseline setting.
  • Driving the consistency and governance of GTO processes through leadership of continuous improvement activities and the crafting and delivery of training.
  • Leading activities to acquire, analyze and deliver high quality targeted information from external partners to advise study design and operational planning decisions.
  • Partnering with study teams to develop and implement effective patient recruitment and retention strategies and tactics.
  • Ability to travel up to 25%

This role may be for you if:
You have expertise in operationalizing clinical development programs in a global setting from first-in-human to post-approval.
You are a compelling communicator with ability to translate sophisticated messages to a variety of audiences
You have a passion for leading teams and building strong working relationships in a diverse range of environments
You have extensive knowledge of clinical trial intelligence data and vendors as well as experience in utilizing data to guide clinical strategy development
You have proven success in process development, implementation and organizational change activities

To be considered, you must have a Bachelor's of Science in a related subject area. You'll need at least 7 years of relevant confirmed experience within pharma/biotech, a CRO or consulting is required. People management experience is also a must.

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.