Manager Precision Medicine

The Manager, Precision Medicine Clinical Laboratory Study Management (CLSM Manager) will lead and develop a team of Clinical Laboratory Study managers (CLSM) for various therapeutic areas including Non-Immuno-Oncology (non-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 Manager, a typical day may include the following:

• 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

• Monitor’s 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 

• 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.

• Oversees Study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing

• Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents

• 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.

• 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

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 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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$128,600.00 - $210,000.00