Genetic Medicine Clinical Development Lead

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); Vor Ort; USD 284.900 - 385.700; Vollzeit

Zusammenfassung

Regeneron is seeking a Medical Director, Clinical Development in Tarrytown, NY, to lead cross-functional teams shaping clinical development strategy for genetic medicines from First in Human through Phase 3.

You will author protocols and regulatory submissions, evaluate candidate programs, oversee trial execution and AE review, and ensure compliance with global guidelines while collaborating with discovery scientists and regulatory colleagues.

Qualifikationen

• MD degree is required; MD/PhD or related research experience preferred.
• Board Certification/Eligibility in Hepatology, Gastroenterology, Endocrinology, or Nephrology preferred.
• 2-3+ years of clinical practice or industry experience preferred.
• Track record of success in clinical or scientific research settings.

Aufgaben

• Lead cross-functional teams to craft novel clinical development strategy for genetic medicines.
• Partner with discovery and translational scientists to understand emerging genetic targets across MASH, metabolism, rare diseases, and other therapeutic areas.
• Author and finalize protocols, amendments, monitoring plans, SAPs, and regulatory submissions.
• Evaluate benefits and risks of assigned therapeutic candidates to inform program decisions.
• Oversee trial execution, including adverse event review and ongoing monitoring of patient health and data quality.
• Ensure team compliance with FDA, EMA, ICH, and GCP guidelines.
• Conduct literature reviews to identify development opportunities from mechanistic, pharmacological, and clinical perspectives.
• Represent clinical science in communications and meetings with regulatory agencies.

Ausbildung

MD degree

Board Certification/Eligibility (Hepatology, Gastroenterology, Endocrinology, or Nephrology)

Jobbeschreibung

Regeneron is seeking a Medical Director, Clinical Development in Tarrytown, NY, to lead cross-functional teams shaping clinical development strategy for genetic medicines from First in Human through Phase 3.

You will author protocols and regulatory submissions, evaluate candidate programs, oversee trial execution and AE review, and ensure compliance with global guidelines while collaborating with discovery scientists and regulatory colleagues.