Regeneron Pharmaceuticals, Inc

Temp - Director Pharmacoepidemiology

Regeneron Pharmaceuticals, Inc • $150K — $180K *
Armonk, NY 10504In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Director level experience in pharmacoepidemiology or related fields
  • 8+ years in the Biotech/Pharma industry
  • Strong understanding of drug development processes
  • Proven ability to manage multiple projects in a matrix environment
  • Exceptional communication and presentation skills
  • Deep knowledge of epidemiologic methods and resources
  • Ability to build relationships with internal and external stakeholders

Responsibilities

  • Develop and implement pharmacoepidemiology strategy for designated therapeutic area
  • Conduct regulatory-required epidemiologic studies for post-marketing commitments
  • Support clinical development and regulatory filings with real-world evidence generation
  • Provide strategic epidemiological support to project and product teams
  • Lead cross-functional teams across various departments
  • Manage relationships with contractors and external vendors
  • Participate in SOP development and process improvement initiatives

Benefits

  • Collaborative and innovative work environment
  • Opportunity to lead cross-functional project teams
  • Access to external experts and thought leaders
  • Support for professional development and training
  • Engagement in strategic and process improvement initiatives
Full Job Description
Discover your role:

The Pharmacoepidemiologist with qualifications commensurate with the Director level will be accountable for development and implementation of pharmacoepidemiology strategy in the designated therapeutic area (TA), leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval, in accordance with global regulations and Regeneron SOPs and working practices. The Pharmacoepidemiologist will serve as an in-house subject matter expert in epidemiology to other departments. The candidate should be knowledgeable in the latest epidemiologic methods and resources to be able to be responsive within cross functional teams and to influence decision making where needed.

Under supervision of the Pharmacoepidemiology Therapeutic Area (TA) lead for General Medicines:
  • Responsible for pharmacoepidemiology strategy generation of real-world evidence (RWE), and conduct of regulatory agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements


  • As a subject matter expert, contribute to other pharmacoepidemiology activities, including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; signal management; responses to regulatory agency queries; regulatory filings
  • Working closely with Global Patient Safety (GPS) Leads, Safety Scientists, Clinical Scientists, Regulatory Affairs and other functions, provide timely epidemiological and risk management strategy and support to project and product teams of TAs including design, implementation and data analysis of epidemiological studies, review of study proposal from internal and external sources, and database activities such as exploring external electronic, patient-level database(s) (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, mortality and morbidities/comorbidities, and other appropriate epidemiologic data in support of clinical development and regulatory filings
  • Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams (SMT), Clinical Study Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees
  • Proactively lead non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory filling)


  • Actively drive and participate in the development and maintenance of relevant SOPs and Working Instructions
  • Actively drive and participate in process improvement activities and strategic initiatives GPS and across Regeneron, as appropriate
  • Manage contractors, and external vendors, as appropriate.
  • Develop and maintain professional relationships and collaborations with external experts and opinion leaders to ensure high quality evidence generation


This role requires:
  • A results-oriented, collaborative style.
  • Ability to build consensus with leaders and colleagues to gain support for initiatives.
  • Proven track record of developing and maintaining relationships with partners at all levels of the organization.
  • Previous experience in and deep understanding of the drug development process.
  • Ability to manage and prioritize multiple tasks and projects with a sense of urgency and to navigate within a matrix organization.
  • Experienced in planning and execution; thinks strategically and executes tactically in order to deliver positive results for the business.
  • Strong business and financial management acumen.
  • Demonstrated resiliency; able and willing to explore different paths to achieve an outcome. Consistently demonstrates good judgment. Takes initiative to bring forward new ideas to improve processes and programs.
  • Outstanding verbal and written communication and presentation skills; ability to communicate accurately and concisely


Education: Minimum of a Bachelors degree and 8+ years of relevant industry related experience in Biotech/Pharma

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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