Senior Manager Clinical Study Lead (Clinical Experimental Sciences) in Cambridge

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. Responsibilities include initiation, oversight, and completion of CES Ops continuous improvement and Strategic Imperatives workstreams.

The Sr. CSL is accountable for oversight of 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; study types include, but are not limited to:

• Less complex data transfer agreements
• Retrospective sample/data acquisition studies
• More complex prospective studies including sample/data acquisition
• Biomarker/technology/method validation
• Genotypic/phenotypic call back studies
• Challenge/screening studies

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

A typical day in this role includes:

• Leading the cross-functional study team responsible for clinical study/research collaboration delivery and being the primary point of contact for leadership and oversight for the assigned study.
• Providing operational input into research plan and/or study protocol development.
• Ensuring 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.
• Overseeing set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint, etc.
• Identifying outsourcing needs of the study and leading and overseeing engagement, contracting, and management of required vendors, if appropriate.
• Providing input into baseline timeline and budget development and management.
• Ensuring accurate budget management and scope changes for internal and external studies.
• Escalating issues related to study conduct, quality, timelines, or budget to Program Operations Leader (POL) and other stakeholders and developing and implementing appropriate actions to address issues.
• Overseeing the execution of the clinical study against planned timelines, deliverables, and budget.
• Ensuring CROs and Third Party Vendors are in alignment and delivering per the scope of work.
• Managing and overseeing study close-out activities.
• Ensuring End of Study Summary is delivered and properly archived.
• Facilitating and contributing to study level lessons learned.
• Assigning tasks to Clinical Study Management staff and supporting their deliverables.
• Recommending and participating in cross-functional and departmental process improvement initiatives.
• Identifying innovative approaches to clinical study execution including global considerations and continuous improvement departmental processes and procedures.
• Working with Therapeutic Focus Area groups within Basic Research/Discovery.
• Communicating learnings, best practices, and relevant information to other study leads at all levels, ensuring consistency and internal alignment across staff.
• May be responsible for direct supervision of CTM staff, including work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training, compliance, and study support/oversight.

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