Senior Manager Clinical Study Lead (Clinical Experimental Sciences)

Senior Clinical Study Lead (CSL) - Clinical Experimental Sciences Operations (CES Ops)

This role is not eligible for remote work and must be onsite in one of our US office locations. The Senior Clinical Study Lead (CSL) - Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical studies/research collaborations from study design, through execution, to study close out. Additionally, there are responsibilities for initiation, oversight and completion of CES Ops continuous improvement and Strategic Imperatives workstreams.

Key Responsibilities

The Sr. CSL is accountable for oversight of the contract and budget execution, study timelines, study budget management, and ensuring study conduct is in accordance with, Regeneron Standard Operating Procedures (SOPs), CES Ops Business Practice Tool processes and ICH/GCP, as applicable. The CES Ops portfolio is dynamic in nature; study types include, but are not limited to, less complex data transfer agreements, retrospective sample/data acquisition studies to more complex prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies.

Interface and Collaboration

This role will interface heavily with Basic Research/Discovery as well as with clinical site staff, predominantly at academic institutions. In rare instances the more complex studies may require out-sourcing to Clinical Research Organizations (CROs); the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role may be responsible for direct line management.

Typical Day in the Role

A typical day in this role looks like:

• Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Provides operational input into research plan and/or study protocol development
• Ensures development of study specific documentation such as samples management plans and data management plans are completed on time and in accordance with the study protocol
• Oversees set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, if appropriate
• Provides input into baseline timeline development and management
• Provides input into baseline budget development and management, facilitates internal review of the study budget for assessment of Fair Market Value
• Ensures accurate budget management and scope changes for internal and external studies
• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
• Oversees the execution of the clinical study against planned timelines, deliverables and budget
• Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
• Manages and oversees study close-out activities
• Ensures End of Study Summary is delivered and properly archived
• Facilitates and contributes to study level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement departmental processes and procedures
• Works closely with Therapeutic Focus Area groups within Basic Research/Discovery
• Works closely with clinical site staff, predominantly at academic institutions

Requirements

To be considered qualified for this role, a minimum of a Bachelors degree and 8+ years of relevant clinical experience is required.

Benefits

Regeneron offers an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.

Regeneron's On-Site Policy

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.

Equal Opportunity Employer

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.

Salary Range

The salary range for this role is $150,500.00 - $245,500.00 annually.