Full-Time

Senior Manager Genetic Clinical Scientist

Posted on 1/15/2025

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

10,001+ employees

Develops medicines for serious diseases

Compensation Overview

$148.3k - $241.9kAnnually

Senior, Expert

Berkeley Heights, NJ, USA + 1 more

More locations: Tarrytown, NY, USA

This is a hybrid role requiring 3 days in the office each week.

Category
Genomics
Biology Lab & Research
Biology & Biotech
Required Skills
Google Cloud Platform
Requirements
  • Bachelor’s Degree
  • Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
  • 6 or more years of pharmaceutical clinical drug development experience
  • Proven knowledge of the drug development process
  • Good Clinical Practice
  • Study design
  • Clinical research methodology
  • Medical writing skills
  • Knowledge of clinical development process
  • Regulatory requirements
  • ICH/GCP guidelines
  • Prior experience with organizational awareness
  • Significant experience working cross-functionally
Responsibilities
  • Facilitates/Leads the writing of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments
  • Identifies key internal and external collaborators/advisors, organizes and conducts consultations with global subject matter experts
  • Represents the clinical genetic medicine function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
  • Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
  • Drafts and reviews clinical sections in regulatory and clinical documents such as regulatory agency briefing books, IND/IMPD submissions, investigator’s brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
  • Reviews study related documents such as medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
  • Trains and supports study team and CRO personnel regarding clinical aspects of trial
Desired Qualifications
  • Demonstrated ability to influence within team and across functions
  • Strong management, interpersonal and problem-solving skills
  • Exhibits strong analytical and influencing skills
  • Ability to communicate concise and clear messages
  • Strong presentation skills
  • Proven track in clinical trial process improvements
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

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Regeneron Pharmaceuticals develops medicines aimed at treating serious diseases such as cancer, eye diseases, and allergic conditions. The company uses its own technologies and extensive research to create new therapies, often collaborating with academic institutions and other pharmaceutical companies to enhance its efforts. Unlike many competitors, Regeneron focuses on both research and commercialization, generating revenue through the sale of its approved medicines and licensing its technologies. The goal of Regeneron is to improve patient outcomes by providing effective treatments and ensuring they meet safety and efficacy standards.

Company Size

10,001+

Company Stage

IPO

Total Funding

$684M

Headquarters

Town of Greenburgh, New York

Founded

1988

Simplify Jobs

Simplify's Take

What believers are saying

  • Dupixent shows promise as the first targeted treatment for bullous pemphigoid.
  • The antibody therapy market is projected to reach USD 824 billion by 2033.
  • Regeneron's collaboration with Axelia Oncology could boost its oncology portfolio.

What critics are saying

  • Increased competition from companies like Amgen and AstraZeneca in antibody therapies.
  • Potential FDA approval delays for treatments like odronextamab.
  • Adverse events with Dupixent could impact regulatory acceptance.

What makes Regeneron Pharmaceuticals unique

  • Regeneron specializes in life-transforming medicines for serious diseases.
  • The company leverages proprietary technologies for innovative drug development.
  • Regeneron collaborates with academic and research institutions to enhance R&D efforts.

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Benefits

Health Insurance

Wellness Program

Paid Vacation

Equity Awards

Annual Bonuses

Flexible Work Hours

Company News

PharmiWeb
Mar 10th, 2025
Dupixent Late-Breaking Positive Pivotal Data In Bullous Pemphigoid Presented At Aad

Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itchDupixent also significantly reduced oral corticosteroid and rescue medicine use compared to placeboData support the potential of Dupixent to be the first and only targeted medicine to treat bullous pemphigoid, a skin disease with underlying type 2 inflammation; regulatory submissions are under review in the US and the EUParis and Tarrytown, NY, March 8, 2025. Positive results from the pivotal ADEPT phase 2/3 study evaluating the investigational use of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP) were shared in a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting. BP is a chronic, debilitating, and relapsing skin disease with underlying type 2 inflammation and characterized by intense itch and blisters, reddening of the skin, and painful lesions.Victoria Werth, MDChief of the Division of Dermatology at the Philadelphia Veterans Administration Hospital, Professor of Dermatology and Medicine at the Hospital of the University of Pennsylvania and the Veteran's Administration Medical Center, and principal investigator of the study“People with bullous pemphigoid live with unrelenting itch, blisters, and painful lesions that can be debilitating and make it difficult to function daily. Moreover, current treatment options can be challenging for this primarily elderly patient population because they work by suppressing their immune system. By targeting the underlying type 2 inflammation, which is a key driver for bullous pemphigoid, Dupixent is the first investigational biologic to show sustained disease remission and reduce disease severity and itch compared to placebo in a clinical study.”The ADEPT study met all primary and key secondary endpoints, enrolling 106 adults with moderate-to-severe BP who were randomized to receive Dupixent 300 mg (n=53) every two weeks after an initial loading dose or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained

PR Newswire
Mar 1st, 2025
Positive Results From Tezspire® (Tezepelumab-Ekko) Phase 3 Waypoint Trial Highlight Rapid, Sustained Effect In Chronic Rhinosinusitis With Nasal Polyps

Significantly Reduced Nasal Congestion, Polyp Size and Nearly Eliminated Need for Surgery. Data Published in NEJM and Presented at AAAAI/WAO 2025. THOUSAND OAKS, Calif., March 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced full results from the Phase 3, registrational WAYPOINT trial demonstrating that TEZSPIRE® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) compared to placebo.1,2 The data were published today in the New England Journal of Medicine and were highlighted as a late-breaking oral presentation during the American Academy of Allergy Asthma Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego.1,2

RegMedNet
Feb 27th, 2025
Cell therapy weekly: world's first hospital-based autologous foundry

At the Research in Otolaryngology's 48th Annual MidWinter Meeting (22 - 26 February 2025; Orlando, FL), Regeneron Pharmaceuticals provided an update on the Phase I/II CHORD trial for DB-OTO, an investigational gene therapy for congenital hearing loss due to OTOF gene variants.

PharmiWeb
Feb 27th, 2025
Odronextamab Bla Accepted For Fda Review For The Treatment Of Relapsed/Refractory Follicular Lymphoma

FDA decision expected by July 30, 2025TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025 .Acceptance of the BLA resubmission follows the achievement of an FDA-mandated enrollment target for the Phase 3 confirmatory trial in R/R FL ( OLYMPIA -1). This was the sole approvability issue identified by the FDA in the complete response letter associated with the previous submission

PharmiWeb
Feb 18th, 2025
Dupixent Sbla Accepted For Fda Priority Review For The Targeted Treatment Of Bullous Pemphigoid

If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision expected by June 20, 2025Priority review granted based on positive pivotal results demonstrating significant improvements in sustained disease remission with Dupixent compared to placeboBP is a chronic, debilitating and relapsing skin disease with underlying type 2 inflammation characterized by intense itch and blisters, reddening of the skin and painful lesionsParis and Tarrytown, NY, February 18, 2025. The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP).The sBLA is supported by data from a pivotal study evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more Dupixent patients achieving sustained disease remission compared to those on placebo. Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 (off OCS treatment and only treated with Dupixent for at least 20 weeks) without relapse and no rescue therapy use during the 36-week treatment period. The study also showed that Dupixent significantly reduced disease severity, itch, and use of OCS compared to placebo.Adverse events more commonly observed with Dupixent (in at least 3 patients) compared to placebo included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infection, limb injury, and insomnia.BP is a chronic, debilitating, and relapsing skin disease with underlying type-2 inflammation that typically occurs in an elderly population. It is characterized by intense itch and blisters, reddening of the skin, and painful lesions

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