Senior Medical Director, Clinical Development — Remote

Agios Pharmaceuticals Inc.; United States; Hybrid; USD 222.000 - 462.000; Vollzeit

Zusammenfassung

Agios Pharmaceuticals is seeking a Medical Director / Senior Medical Director to lead clinical development programs, including pivotal trials and NDA filings, and to provide medical input to regulatory strategies.

The role offers Location Agnostic work with remote options in the US or hybrid work at our Cambridge Headquarters, reflecting our collaborative culture and commitment to rare disease patients.

Qualifikationen

• Board certification or eligibility in internal medicine or pediatrics; hematologic diseases desirable.
• 3–10 years in biotech/pharma clinical development or related functions.
• Experience with trial design in POC through Phase 3 and NDA filings.

Aufgaben

• Design trial concepts for Phase I–III in rare/orphan diseases.
• Support open-label extensions and lifecycle management.
• Supervise trial conduct and coordinate with external medical monitors.
• Provide medical input to global regulatory plans and meetings.
• Collaborate with safety teams and global safety leads.
• Engage with CROs and external experts for oversight of studies.
• Assess therapeutic candidates and identify design/execution challenges.
• Coordinate with project management to track trial status.
• Ensure regulatory compliance and medical quality of documents.

Kenntnisse

Board certification/eligibility

Clinical development experience

Public speaking skills

Jobbeschreibung

Agios Pharmaceuticals is seeking a Medical Director / Senior Medical Director to lead clinical development programs, including pivotal trials and NDA filings, and to provide medical input to regulatory strategies.

The role offers Location Agnostic work with remote options in the US or hybrid work at our Cambridge Headquarters, reflecting our collaborative culture and commitment to rare disease patients.