Regeneron Pharmaceuticals, Inc

Manager Precision Medicine

Regeneron Pharmaceuticals, Inc • $128K — $210K *
Armonk, NY 10504In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree required
  • 8+ years of pharmaceutical experience, preferably in a pharma, biotech, or academic setting
  • 5+ years of experience in clinical trials focused on clinical sample collection
  • Extensive knowledge of clinical laboratory operations and biospecimen logistics
  • Strong understanding of technical and strategic aspects of laboratory operations delivery

Responsibilities

  • Lead and develop a team of Clinical Laboratory Study Managers (CLSM)
  • Collaborate with clinical study teams to set up lab databases for sample collection
  • Monitor clinical trial sample acquisition and compliance with ICF permissions
  • Assist clinical study teams with technical and operational sample-related issues
  • Oversee lifecycle activities of studies at central/specialty labs
  • Provide input on sample sections in clinical trial protocols and documents
  • Ensure accurate data transfer specifications and manage sample/testing data collaboration with stakeholders

Benefits

  • Opportunities for professional development and advancement
  • Strong collaborative work environment
  • Access to comprehensive health and wellness programs
  • Involvement in cutting-edge precision medicine research
  • Supportive management focused on mentorship and growth
Full Job Description

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.

Salary Range (annually)

$128,600.00 - $210,000.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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