Senior Director, Clinical Development – I&I Strategy Lead

Rival; Watertown (MA); On-site; USD 330,000 - 355,000; Full time

Job summary

Triveni Bio in Watertown, MA, seeks a Senior Director, Clinical Development to lead the clinical strategy and study execution for immunology and inflammatory programs. You will drive medical leadership across studies, contribute to protocol development, safety reviews, data interpretation, regulatory submissions, publications, and presentations.

This role requires strong cross‑functional leadership and regulatory acumen.

Qualifications

• MD required; significant I&I or rare disease clinical development experience preferred.
• Minimum of 8+ years in clinical research and drug development with a track record of success.
• Experience designing and executing clinical programs across phases and regions; phase 1/2 experience required.

Responsibilities

• Develop multi-year clinical development strategy and medical plans across US, Europe, and other jurisdictions.
• Provide medical leadership to cross-functional program teams through all phases of development.
• Lead safety monitoring, pharmacovigilance oversight, and safety data reviews.
• Oversee regulatory submissions (INDs, CTAs, briefs) and health authority interactions.
• Collaborate with Research, Operations, and other functions to drive program decisions.
• Engage investigators, KOLs, and external partners; support advisory boards and scientific congresses.

Skills

Clinical leadership

Regulatory knowledge

Cross-functional collaboration

Strategic thinking

Education

MD degree

Job description

Triveni Bio in Watertown, MA, seeks a Senior Director, Clinical Development to lead the clinical strategy and study execution for immunology and inflammatory programs. You will drive medical leadership across studies, contribute to protocol development, safety reviews, data interpretation, regulatory submissions, publications, and presentations.

This role requires strong cross‑functional leadership and regulatory acumen.