Senior Director, Immunology Clinical Development

Triveni Bio; Watertown (MA); On-site; USD 230,000 - 320,000; Full time

Job summary

Triveni Bio is seeking a Sr. Director, Clinical Development to lead clinical strategy and study execution for I&I programs. The role partners with internal and external stakeholders to shape medical plans, safety reviews, data interpretation, and regulatory submissions, ensuring ICH-GCP compliance.

This senior leadership position requires guiding cross-functional teams across phases and geographies, with strong expertise in clinical development and regulatory interactions.

Qualifications

• M.D. is required with substantial I&I or rare disease clinical development experience.
• Minimum of 8+ years in clinical research and drug development across academia, biotech, and pharma.
• Experience designing and executing multi-phase clinical programs across regions.
• Strong knowledge of GCP, ICH guidelines, regulatory requirements, and drug development.
• Proven ability to lead teams of direct reports and contractors.

Responsibilities

• Develop and execute a multi-year clinical development strategy for programs in I&I.
• Provide medical leadership across clinical studies and regulatory submissions.
• Lead medical monitoring and oversight of safety data in accordance with protocols.
• Collaborate with regulatory agencies and cross-functional teams to advance programs.
• Support advisory boards, KOL engagement, and external partnerships.

Skills

Medical leadership

Strategic planning

Regulatory affairs

Cross-functional leadership

Communication

Education

MD

Job description

Triveni Bio is seeking a Sr. Director, Clinical Development to lead clinical strategy and study execution for I&I programs. The role partners with internal and external stakeholders to shape medical plans, safety reviews, data interpretation, and regulatory submissions, ensuring ICH-GCP compliance.

This senior leadership position requires guiding cross-functional teams across phases and geographies, with strong expertise in clinical development and regulatory interactions.