Regeneron Pharmaceuticals, Inc

Senior Medical Director, Clinical Development, Ophthalmology

Regeneron Pharmaceuticals, Inc • $333K — $450K *
Tarrytown, NY 10591In-Person
Healthcare
Less than 5 years of experience
2 months ago
Job Overview by Ladders

Qualifications

  • M.D. or D.O. or equivalent medical degree with relevant training
  • Board certified or eligible Ophthalmologist required
  • Minimum of 4 years of industry experience in clinical development
  • Experience leading proof of concept and registrational trials
  • Strong knowledge of compliance and global regulatory standards (ICH)
  • Commitment to clinical research and teamwork
  • On-site presence required 4 days a week in specified locations

Responsibilities

  • Lead clinical development programs for the Ophthalmology portfolio
  • Collaborate with multidisciplinary teams to refine clinical strategies
  • Design innovative Phase 1, 2, and 3 clinical programs
  • Ensure the safety of patients in clinical studies
  • Oversee quality of clinical documents and regulatory submissions
  • Engage external stakeholders, including regulatory and opinion leaders
  • Facilitate consensus-building within clinical teams

Benefits

  • Work in a dynamic, fast-paced environment
  • Opportunity to play a pivotal role in advancing ophthalmic treatments
  • Collaborative culture with diverse, multidisciplinary teams
  • Potential for innovative contributions to clinical strategies
  • Exposure to high-level decision-making across various departments
Full Job Description
The Senior Medical Director will play a key role in clinical development programs within the Ophthalmology portfolio, including being accountable for deliverables of the assigned program(s), supporting resourcing, budget, and timelines of these programs. This role serves as scientific and medical lead for clinical team(s) working closely with operational leads. This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research.

The incumbent will collaborate with multi-disciplinary clinical teams, assisting in guiding and executing clinical development strategies and subsequent regulatory submissions. This role is responsible for the design and execution of first-in-human through registration-enabling studies. This role will serve as a representative to a range of audiences, including Internal Medicine leadership, executive leadership, development partners, and US and global regulatory agencies. The Senior Medical Director, Ophthalmology reports to the Vice President, Ophthalmology Therapeutic Area Lead.

A typical day in the life of a Senior Medical Director, Clinical Development may include the following:
  • Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Global Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards.
  • Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops more efficient and innovative, yet robust Phase 1, 2, and 3 programs.
  • Works closely with the research and discovery teams to provide input on the next generation of targets in the field.
  • Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
  • Ensures quality of all clinical documents (e.g., investigators' brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
  • Develops written responses to regulatory agency questions and prepares regulatory submission documents.
  • Has strong consensus-building skills and the ability to collaborate with multi-disciplinary teams towards sound decision-making. Key member of dynamic and matrixed clinical teams in a fast-paced and hands-on environment.

This role may be for you if you have the following:
  • A M.D. or D.O. or equivalent medical degree and relevant training
  • A trained Ophthalmologist (board certified or eligible or equivalent) is essential.
  • A minimum of 4 years of industry experience (early or late clinical development); however, a candidate with a strong academic background and less experience may be considered.
  • Experience in leading proof of concept and/or registrational clinical trials, including protocol design, managing study start-up, directing, and guiding study team execution, data cleaning, medical monitoring/review, database locks.
  • Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidate products is required.
  • A strong commitment to clinical research and the ability to work well within a team setting are essential.
  • This role requires 4 days a week on-site in Tarrytown, NY, Cambridge, MA, or Warren, NJ


#MDJobs, #MDJOBSCD, #GDTherapeuticJobs, SKC

Salary Range (annually)

$333,300.00 - $450,900.00

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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