Description

This role is not eligible remote, 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. 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. This role will interface heavily with Basic Research/Discovery as well as with clinical site staff, predominately 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.

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 with Therapeutic Focus Area groups within Basic Research/Discovery
Works closely with clinical site staff, predominantly at academic institutions
Expected to maintain higher volume and/or greater complexity studies
Expected to communicate learnings, best practices and relevant information to other study leads at all levels, ensures consistency and internal alignment across staff
May be responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

In order to be considered qualified for this role, a minimum of a Bachelor's degree and8+ years of relevant clinical experience is required.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have 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.
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.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$150,500.00 - $245,500.00

Senior Manager Clinical Study Lead (Clinical Experimental Sciences)

Description

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