Senior Manager, Clinical Lab Study Manager
Company: Regeneron Pharmaceuticals, Inc.
Location: Armonk
Posted on: February 22, 2026
|
|
|
Job Description:
The Senior Manager, Precision Medicine Clinical Laboratory Study
Management (CLSM Senior Manager) will lead and develop a team of
Clinical Laboratory Study managers (CLSM) for various therapeutic
areas including Immuno-Oncology (IO). In this role, you will be a
key driver of precision medicine operational execution partnering
with Precision Medicine Strategy Lead (PMSL), clinical study teams,
data management (DM), Samples, Kits, Data, Logistics (SKDL),
Clinical Laboratory Study Manager (CLSM), and Clinical Laboratory
Project Management (CLPM) groups to deliver high-quality samples
and data. Through strong cross functional collaboration and
operational excellence, you will help ensure biomarker and
non-biomarker strategies are executed seamlessly, enabling the
translation of innovative science to medicines for patients. As a
CLSM Senior Manager, a typical day may include the following:
Clinical Trial Study Team Support Participates in cross-functional
study teams and sub-teams across clinical and research departments
Works with project manager and set-up manager of central/specialty
lab and clinical study team to build lab database to address
clinical trial sample collection needs, kits, testing and logistics
Monitors acquisition of clinical trial samples (including human
tissue, bone marrow aspirate, whole blood, plasma, serum, etc.) and
ensure compliance with ICF permissions Supports individual clinical
study teams as required for all technical and operational
sample-related matters for assigned projects by liaising with
internal stakeholders working on ICF and other trial documents
impacting samples and testing Support cross functional internal and
external collaborators to manage and support the generation of
high-quality laboratory data. Work closely with central lab and/or
specialty lab project managers, clinical trial management team, and
CRO to ensure samples are collected per protocol and assist with
resolving any sample related issues or queries. Serves as CLSM
subject matter expert contact for assigned therapeutic areas
including IO. Allocates and prioritizes FSP CLSM and Sr. PMA
resources within the assigned therapeutic program and studies.
Manages FSP CLSM team for technical and operational support on
their assigned therapeutic program and studies. Operational Support
of Sample Analysis (Including Exploratory Analysis) Oversees Study
start up, closeout and overall life-cycle activities for assigned
studies at central lab/specialty labs to support all samples and
testing Forecasts sample related operational costs and reviews
invoices to ensure we are aligned with budget plans Provides input
on sample-related section in clinical trial-related (e.g. protocols
and ICF) and other supporting documents Prepares RFPs, reviews and
assess bids and SOWs for items related to samples and testing
Provides guidance and trainings to vendors, collaborators and
clinical sites on sample collection, processing, shipping, and
storage Data Acquisition and Management Works closely with data
management lead and SKDL to determine how sample and testing data
will be captured, blinded and transferred for clinical trials.
Enables transfer of sample/testing data from vendors through
development and review of appropriate data transfer specification
and related documents in collaboration with SKDL. Human Sample
Management Flow and Compliance Provides guidance to clinical teams
and clinical sites regarding collection and storage of samples
acquired during clinical trials or other human sample acquisition
projects Works with scientists and clinical team to ensure sample
collection and usage is in compliance with study protocol and
applicable ICF Collaborates with internal Human Sample Management
team to ensure all samples transferred to internal research groups
are documented, tracked, used, and destroyed This role may be for
you if: You possess strong leadership tendencies, ability to
proactively identify problems, determine resolutions, set
priorities, and direct projects and work cross-functionally to
manage expectations with excellent communication and collaborative
skills and work well in a team-based environment. The CLSM Senior
Manager will be responsible for day-to-day oversight of multiple
CLSMs, including responsibility for coaching, mentoring and
performance management ensuring applicable key trial level
milestones are achieved on schedule. You demonstrate strong
leadership skills and possess high level of emotional intelligence
and effectively work collaboratively with colleagues, vendors and
internally at Regeneron to ensure program success. To be considered
for this role, you must have a Bachelors, Minimum of 8 years
pharmaceutical experience in matrix interaction preferably in a
pharmaceutical or biotech industry, or in academic or governmental
cross-disciplinary teams. Minimum of 5 years experience with
Clinical Trials, focus on clinical sample collection. Extensive
experience in Clinical laboratory operations, biospecimen
logistics, and/or clinical study experience requested. We need a
strong understanding of technical, clinical, and strategic aspects
of laboratory operations delivery required. We are seeking clinical
study knowledge, demonstrated by knowledge in science and
technology. Demonstrated experience in stake holder management,
leading internal and external meetings and solutioning skills. 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 Regenerons roles are required to be performed
on-site. Please speak with your recruiter and hiring manager for
more information about Regenerons 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) $134,400.00
- $219,200.00
Keywords: Regeneron Pharmaceuticals, Inc., Springfield , Senior Manager, Clinical Lab Study Manager, Science, Research & Development , Armonk, Massachusetts