Senior Director, Clinical Development

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

COMPANY INTRODUCTION

Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.

SUMMARY

The Senior Director, Clinical Development will lead the clinical strategy and study execution of our I&I development programs. Working closely with internal and external stakeholders, this individual will drive clinical development plans, provide medical leadership across clinical studies, and contribute to study design, protocol development, safety reviews, data interpretation, regulatory submissions, publications, and presentations. As a key member of the development leadership team, this individual will guide cross-functional activities to achieve program objectives while ensuring compliance with ICH-GCP and applicable regulatory requirements.

RESPONSIBILITIES

Clinical Strategy & Leadership

• 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 potential 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.

Clinical Trial Design & Execution

• Drive the development of clinical content including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports
• Lead Medical Monitoring, or provide oversight and guidance to designated Medical Monitors, across clinical programs; provide medical oversight, review safety data, and ensure adherence to protocol and regulatory standards.
• Partner with clinical operations to support site selection, investigator training, and issue resolution during study conduct.

Safety & Compliance

• Oversee the assessment and interpretation of safety data, including adverse events, safety signals, and risk mitigation strategies.
• Oversee pharmacovigilance to ensure timely evaluation and reporting of safety information.
• Ensure clinical programs follow ICH-GCP, ethical standards, and regional/global regulatory requirements.

Regulatory & Scientific Communication

• Contribute to the preparation and review of regulatory submissions including INDs, CTAs, briefing documents, and NDAs/BLAs.
• Represent the clinical program in interactions with health authorities such as FDA, EMA, and other global agencies.
• Develop and review key clinical documents including protocols, investigator brochures (IBs), clinical study reports (CSRs), and publications.

Cross-Functional Collaboration

• Partner cross-functionally with Research and Operations functions
• Provide medical and scientific expertise for internal decision-making, including business development activities as required
• Support advisory boards, KOL engagement, and scientific congress activities.

External Engagement

• Build and maintain relationships with investigators, key opinion leaders, and external experts.
• Stay current on scientific advances, competitive intelligence, and therapeutic area trends to inform program direction.

EXPERIENCE & QUALIFICATIONS

• M.D. required; significant I&I or rare disease clinical development experience strongly preferred
• Minimum of 8+ years of relevant experience with a demonstrated track record of success in clinical research and drug development within academia, biotechnology, and/or the pharmaceutical industry.
• Demonstrated experience designing and executing clinical programs across multiple phases and geographic regions.
• Experience with phase 1/2 clinical studies is required
• 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 experience engaging regulatory agencies, investigators, KOLs, and external partners.
• Excellent analytical, strategic, and communication skills.
• Experience authoring and reviewing key clinical and regulatory documents and contributing to global regulatory submissions and health authority interactions.

The posted range reflects the current reasonable and good faith estimate of the base salary for this full-time position. Actual compensation will be based on a variety of factors including, but not limited to, relevant skills and experience, educational background and certifications, performance and qualifications, market demand for the role, geographic location and other organizational needs.

• competitive target bonus, equity, and a comprehensive benefits package.

We are committed to fair pay practices, and we regularly review our compensation programs to ensure they are competitive, equitable, and aligned with our values. Please note that the advertised pay range is not a guarantee or promise of a specific wage.