This role is a hybrid position and requires the colleague to be on-site a minimum of 3 days. Remote work is not an option for this position.
The Senior Director Global Site Start-Up (GSSU) is responsible for leadership and overall strategic management of site start-up activities for Regeneron’s clinical trial portfolio across all therapeutic areas and phases for both CRO handled and internally run. The Sr. Director GSSU will develop and drive strategic leadership, vision, growth, and deliverables for the GSSU organization; strategies will be implemented at the study and program level, and, through vendors and external collaborators. As a leader within the Global Clinical Trial Services (GCTS) group, the Senior Director will engage and work closely with other cross functional partners and senior leaders within Development Operations and Portfolio Planning (clinical study teams, senior level management, and external vendors) to align and implement a portfolio-wide Study start-up strategy. This role requires in-depth knowledge of the SSU, clinical trials and the ability to connect to Regeneron’s goals. The Sr. Director GSSU reports to the Head of Global Clinical Trial Services (GCTS) and is a member of the GCTS Senior Leadership Team.
In a typical day, you will:
- Direct, develop, and drive SSU strategy implementation that aligns with the Global Development organization’s direction. Effectively communicate and acquire agreement on SSU strategies from related organizations and with our CROs. Relentlessly drive the strategies into study teams and monitor progress. Able to quickly read the status and adjust the strategy as needed
- Build and lead a team of individuals who support clinical trial teams through study start up and execution
- Builds & fosters strong working relationships with clinical study teams (e.g., Clinical Trial Management, Global Trial Optimization, Global Site Monitoring, Clinical Drug Supply & Logistics, Legal, Regulatory, Development Program Management, Clinical Quality Assurance)
- Build a close relationship with Global Trial Optimization to facilitate and expedite feasibility and site selection through activation
- Assesses intangible variables, identifies fundamental issues, and develops strategies for high quality, rapid site openings across the portfolio which entails building cross functional alignment, influencing CROs in completing clinical trials and overall responsibility for site start up activities in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs)
- Leads and evolves the business processes and strategies that enable the SSU group to ensure timely delivery of the entire development portfolio and oversee work done through CROs. This includes designing an organization that can implement and manage SSU across internal and externally run studies
- Develops and monitors the overall health of study start up for the clinical trial portfolio through review of metrics, analytics (dashboards) and performs escalation and risk mitigation, as appropriate. Analyzes Key Performance Indicators (KPIs) and various operational metrics as part of continuous improvements
- Develops, implements, and leads sourcing strategies for site start up related activities that align with related functional strategies. Responsible for overall management of outsourced services according to landmarks and quality standards
This job may be for you if you have:
- 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 complex messages to a variety of audiences.
- Proven ability to build strong working relationships in a diverse range of team environments, including Vendor & Relationship Management, Clinical Study Contracts & Budgets, Regulatory/Ethics committee/IRB interactions, Clinical Drug Supply and Logistics, and Regulatory Compliance
- Experience in using data to advise clinical strategy development
- Ability to understand sophisticated business questions and develop effective solutions
- Experience in process development, implementation and change management activities
- Ability to make independent decisions that impacts across the organization with less than perfect inputs
- Thrives in a highly dynamic environment where creativity is key in meeting the needs of key partners
- Able to handle abstract ideas and concepts while also using abstract ideas to solve complex problems where there is minimal precedent
- Self-motivated, good interpersonal and leadership skills, a teammate
- Line management experience
To be considered you must have a Bachelor's degree and 15+ years’ pharmaceutical industry experience with at least 10+ years of functional leadership experience in study start-up/clinical operations and 10+ years people management experience. 30% travel required.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)