Senior Manager, Global Trial Optimization
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. In this role, you will play a key role in developing and managing 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.
In this role, a typical day might include:
- Leading study level feasibility processes to generate high quality and timely data to inform study design, optimal geographical placement and operational planning.
- Partnering with teams during CRO led feasibility activities to support validation of study and country level enrollment rates and study start up timelines to drive budget and baseline setting.
- Supporting the development and implementation of the Global Trial Optimization function through process initiatives and change management activities.
- Collaborating 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.
- Articulating the data story to teams based on country level feasibility and centrally derived data to support data driven decisions to improve protocol design
- Leading 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.
- Supervising study level engagements to acquire, analyze and deliver high quality targeted information from external partners to support design and planning decisions.
- Managing study level tasks to generate and deliver patient level insights as required
- Provide input into diverse continuous improvement activities to ensure consistency of GTO process execution.
- In partnership with Clinical Outsourcing, providing functional input into the identification, qualification and relationship management of a range of vendors
- Partnering with study teams to develop and implement patient recruitment and retention tactics aligned with defined study strategy
- Developing and maintaining knowledge of external clinical trial environment and assessing developments for impact on study design and execution.
This role might be for you if:
You have proven experience operationalizing clinical development programs in a global setting from first-in-human to post-approval
You are a compelling communicator with the ability to translate sophisticated messages to a variety of audiences.
You can build strong working relationships in a diverse range of team environments
You have experience in utilizing data to inform clinical strategy development
You have the ability to understand complex business questions and develop effective solutions
You're passionate about process development, implementation and change management
You thrive in a highly dynamic environment where creativity is key in meeting the needs of key partners
To be considered, you must have a Bachelor's degree and at least seven years of relevant industry experience within pharma/biotech, a CRO or consulting. Line management experience is 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. #LI-EG1