Assoc Director, Program Operations Leader Clinical Experimental Science Operations

The Associate Director (AD), Clinical Experimental Science Operations (CES Ops) is responsible for leadership within the group and supports strategic management of clinical research studies across the early development experimental science portfolio (e.g. biomarker development studies, platform validation studies, technology/innovation pilots, sample collection studies) within Clinical Trial Management & Global Monitoring (CTM&GM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct is in accordance with Regeneron Standard Operating Procedures (SOPs), CES Ops mentorship's and ICH/GCP, as applicable. Additionally, there are responsibilities for ownership and leadership of CES Ops continuous improvement and Strategic Imperatives workstreams, with a focus on ensuring cross functional alignment and process improvement that supports the guiding principles and vision of the group. The CES Ops portfolio is dynamic in nature, study types include, but are not limited to, less sophisticated data transfer agreements, retrospective sample/data acquisition studies to more sophisticated prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies. In rare instances the more sophisticated studies may require out-sourcing to Clinical Research Organizations (CROs); the balance of direct leadership versus oversight will vary accordingly. This role will interface heavily with Basic Research/Discovery as well as with clinical site staff, predominately at academic institutions. This role will be responsible for direct line management including responsibility for staff recruitment, development, coaching, mentoring and performance management.

A typical day in this role might look like...

• Chips in to the overall success of CES Ops portfolio delivery and may serve as a point of contact for leadership and oversight for the CES Ops team
• Chips in to the direction, strategy and interpersonal development for the CES Ops team
• Provides strategic decision making and integrates all operational considerations for studies to ensure goals are attainable prior to implementation
• Maintains an overview of clinical study status and issues and proactively communicates' progress, risks, issues or changes that may impact quality, timelines and/or budget; provides updates to partners, including senior
• Is responsible for clinical study budgets: ensures review, presentation and approval of study budget and leads the budget and raises concerns to Head CES Ops, as appropriate
• Ensures timely delivery of quality operational results and accountable for ensuring consistency of process and approaches across the portfolio
• Reviews key metrics and Key Performance Indicators (KPIs) across studies within CES portfolio to identify trends and build mitigation strategies
• Provides innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
• Chips in to resource forecasting and resource allocation for assigned portfolio
• Responsible for direct supervision of staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
• May require up to 25% travel

This role might be for you if.....

• Bachelor’s degree and minimum of 10 years relevant industry experience.
• Experience in non-interventional research or similar projects/research
• Experience in operational execution, process evaluation and development related to exploratory/experimental research study conduct
• Working knowledge of regulations and requirements for exploratory/experimental research studies
• Analytical skills with a data driven approach to planning, executing, and problem solving
• Effective interpersonal skills via verbal, written and presentation abilities
• Strong project management, cross-functional team leadership and interpersonal skills
• A solid understanding of GCP and ICH

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)

$165,900.00 - $270,700.00