Senior Director, Clinical Development - Global I&I Leader

Rival; Northern (KY); Hybrid; USD 330,000 - 355,000; Full time

Benefits offered by this job

Target bonus

Equity

Benefits package

Job summary

Triveni Bio is seeking a Senior Director, Clinical Development to lead the clinical strategy and study execution across I&I programs. You will guide medical leadership, design development plans, and oversee safety reviews, regulatory submissions, publications, and presentations in collaboration with cross-functional teams.

In this role, you will interact with health authorities (FDA/EMA) and external partners, ensure ICH‑GCP compliance, and drive study design and execution across multiple

Qualifications

• MD required with extensive I&I or rare disease clinical development experience.
• Design and oversight of multi-phase, multi-region clinical programs.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.

Responsibilities

• Develop and execute a multi-year clinical development strategy for programs.
• Provide medical leadership across US, Europe, and other jurisdictions.
• Oversee safety reviews, pharmacovigilance, and regulatory compliance.
• Lead preparation of regulatory submissions (INDs/CTAs/NDAs) and health authority interactions.
• Collaborate cross-functionally with Research, Operations, and business development.
• Engage with investigators, KOLs, and external partners to advance programs.

Skills

Clinical development

Medical leadership

Regulatory submissions

Safety oversight

Cross-functional leadership

ICH-GCP knowledge

Education

MD

Job description

Triveni Bio is seeking a Senior Director, Clinical Development to lead the clinical strategy and study execution across I&I programs. You will guide medical leadership, design development plans, and oversee safety reviews, regulatory submissions, publications, and presentations in collaboration with cross-functional teams.

In this role, you will interact with health authorities (FDA/EMA) and external partners, ensure ICH‑GCP compliance, and drive study design and execution across multiple