Regeneron Pharmaceuticals, Inc

Director, Global Patient Safety Sciences - General Medicine

Regeneron Pharmaceuticals, Inc • $205K — $341K *
Dublin, CA 94568In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • Minimum 10+ years of relevant experience in pharmacovigilance or drug safety, including PSURs/DSURs/RMPs.
  • 5+ years in a relevant medical field with a PharmD, PhD, or MD degree required.
  • Experience in clinical development or safety in Oncology is a plus.
  • Proven ability to lead and nurture a diverse team of safety professionals.
  • Expertise in applying FDA, EU, and ICH guidelines governing pharmacovigilance activities.

Responsibilities

  • Oversee all Global Patient Safety activities for assigned compounds and products.
  • Lead cross-functional Safety Monitoring Team activities.
  • Represent Global Patient Safety on strategic cross-functional teams.
  • Develop safety strategies for non-compound specific activities.
  • Provide medical review for complex Individual Case Safety Reports (ICSRs).
  • Develop and maintain relevant standard operating procedures (SOPs).
  • Drive continuous improvement initiatives and mentor junior safety scientists.

Benefits

  • Medical, dental, vision, life, and disability insurance.
  • 401(k) company match and equity awards.
  • Annual bonuses and paid time off.
  • Family support benefits, including military and parental leave.
  • Access to fitness centers and health and wellness programs.
Full Job Description

The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s)/asset(s) assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety strategy. This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron’s industry leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global territories.

In this role, a typical day might include:

  • This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management,  communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs,  etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.)

  • Leads cross-functional Safety Monitoring Team (SMT) activities

  • Represent Global Patient Safety for assigned compounds on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT) and other teams with members external to Regeneron (alliance partners, CROs)

  • Proactively identify and develop safety strategies and planning for non-compound specific Global Patient Safety activities (mechanism of action etc.)

  • Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds

  • Actively participate in the development and maintenance of relevant SOPs, working practices and guides 

  • Actively participates in continuous improvement activities within both the TA and the GPS organization, including cultivating cross functional relationships and mentoring junior safety scientists

This role might be for you if can/have:

  • Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

  • Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest.

  • A proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.

  • An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.

  • Ability to utilize GPS safety database for purposes of medical case review and simple queries. 

To be considered for this opportunity, you must have the following:

  • Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content). 

  • 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree required.

  • Clinical experience and/or industry experience in Oncology is a plus

#MDJOBSPS #GDPSJobs

Salary Range (annually)

$205,000.00 - $341,600.00

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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