Global Medical Lead, Rare Disease Clinical Development

Rhythm Pharmaceuticals, Inc; Boston (MA); Hybrid; USD 230,000 - 330,000; Full time

Job summary

Rhythm Pharmaceuticals, Inc. seeks an experienced physician to join its Clinical Development team in Boston, MA. The role oversees Medical Lead responsibilities across studies involving setmelanotide and pipeline programs, ensuring patient safety and trial integrity.

The ideal candidate has 8–10 years in clinical development within pharma/biotech, with leadership across global programs, regulatory interactions, and a strong regulatory submission background.

Qualifications

• Medical Degree & Certification: MD or equivalent; Board Certification in endocrinology, pediatrics, genetics, internal medicine, or related specialty preferred.
• Clinical Development Experience: 8–10 years in pharma/biotech with global development programs and regulatory interactions.
• Clinical Development Leadership Experience: Proven senior medical leader mentoring and cross-study leadership.
• Trial Phase Track Record: Design, oversight, and execution across Phase 1–3, including registrational studies.
• Regulatory Submissions & Interactions: Lead components of global filings and direct agency interactions (FDA/EMA).
• GCP, Compliance & Safety Standards: Deep expertise in GCP/ICH, pharmacovigilance, and ethical conduct.
• Leadership & Matrix Influence: Ability to lead cross-functional teams and mentor others.
• Strategic Mindset: Balance science, patient needs, regulatory requirements, and business priorities.
• Executive Communication: Clear communication to diverse internal and external audiences.
• Travel: Willingness to travel domestically and internationally (up to 20%).

Responsibilities

• Serve as Clinical/Medical Lead across multiple complex studies and development programs, ensuring high-quality trial execution and patient safety.
• Lead creation and execution of Clinical Development Plans and study protocols for new indications and lifecycle management.
• Provide strategic medical leadership across cross-functional matrix teams (Clinical Operations, Biostatistics, Data Management, Regulatory, Medical Affairs, Translational Research, Drug Safety).
• Oversee medical monitoring activities including eligibility evaluation, protocol deviations, endpoints, and emerging issues.
• Provide clinical safety leadership and collaboration with Pharmacovigilance for safety evaluations.
• Lead regulatory document authoring, review, and defense (INDs, IBs, CSRs, NDA/BLA/MAA) with FDA/EMA.
• Interpret complex clinical data; support data communication and scientific dissemination.
• Establish and maintain relationships with KOLs, investigators, and study sites; support SABs/DSMBs.
• Mentor and develop Medical Directors and cross-functional teams; promote knowledge sharing and leadership growth.

Skills

Clinical leadership

Regulatory interactions

Medical monitoring oversight

Cross-functional leadership

Executive communication

Strategic mindset

Global regulatory strategy

Travel readiness

Education

Doctor of Medicine (MD) or equivalent

Board Certification in Endocrinology / Pediatrics / Genetics / Internal Medicine

Job description

Rhythm Pharmaceuticals, Inc. seeks an experienced physician to join its Clinical Development team in Boston, MA. The role oversees Medical Lead responsibilities across studies involving setmelanotide and pipeline programs, ensuring patient safety and trial integrity.

The ideal candidate has 8–10 years in clinical development within pharma/biotech, with leadership across global programs, regulatory interactions, and a strong regulatory submission background.