Senior Director, Clinical Development - I&I Strategy Lead

Socket.dev; Watertown (MA); On-site; USD 200,000 - 320,000; Full time

Benefits offered by this job

Competitive bonus

Equity

Comprehensive benefits

Job summary

Triveni Bio is seeking a Senior Director, Clinical Development to lead the clinical strategy and execution for its I&I programs. You will guide medical leadership across studies, align cross-functional teams, and ensure compliance with ICH‑GCP and global regulations.

You will drive multi‑year development plans, oversee trial design, safety, and regulatory submissions, and communicate with health authorities while partnering with external experts to advance the program toward INDs and potential

Qualifications

• MD required; significant I&I or rare disease clinical development experience preferred.
• 8+ years of relevant experience in clinical research and drug development.
• Experience designing and executing clinical programs across multiple phases and geographic regions.
• Strong knowledge of GCP, ICH guidelines, global regulatory requirements, and the drug development process.
• Experience building and leading a team of direct reports and contractors.
• Proven medical and scientific leadership of cross-functional teams with regulatory engagement.
• Excellent analytical, strategic, and communication skills.
• Experience authoring and reviewing key clinical and regulatory documents and submissions.

Responsibilities

• Develop and execute a multi-year clinical development strategy for our clinical programs.
• Lead creation and execution of medical plans across the US, Europe, and other jurisdictions.
• Provide medical leadership and scientific guidance to a cross-functional program team through all phases of clinical development.
• Evaluate and integrate emerging scientific, clinical, and competitive insights into development strategies.
• Drive development of protocols, amendments, IBs, ICFs, and CSRs.
• Lead Medical Monitoring and oversight of safety data and regulatory compliance.
• Partner with clinical operations for site selection, investigator training, and issue resolution.
• Oversee pharmacovigilance and ensure timely safety reporting.
• Represent the program in interactions with FDA, EMA, and other agencies.
• Prepare regulatory submissions and health authority communications.
• Collaborate with Research and Operations; support business development and advisory boards.

Skills

Medical leadership

Regulatory knowledge

Cross-functional collaboration

GCP/ICH knowledge

Strategic thinking

Communication skills

Education

MD

Job description

Triveni Bio is seeking a Senior Director, Clinical Development to lead the clinical strategy and execution for its I&I programs. You will guide medical leadership across studies, align cross-functional teams, and ensure compliance with ICH‑GCP and global regulations.

You will drive multi‑year development plans, oversee trial design, safety, and regulatory submissions, and communicate with health authorities while partnering with external experts to advance the program toward INDs and potential