Sr. Director - Clinical Affairs

Lifestylelily

Indianapolis, Indiana, US
Base: $156,000 - $288,200; bonus/equity: compyny b...
Gene therapy clinical development
Clinical trial strategy and execution
Regulatory compliance (ich, gcp)
The Sr. Director of Clinical Affairs will play a pivotal role in the clinical development of gene therapy programs, overseeing strategic planning, execution, and management of clinical trials

Job Summary

  • The Sr. Director of Clinical Affairs will play a pivotal role in the clinical development of gene therapy programs, overseeing strategic planning, execution, and management of clinical trials.
  • This position will ensure that clinical studies are conducted in compliance with regulatory requirements, scientific standards, and company goals.
  • Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Matching Summary

The Sr. Director of Clinical Affairs will play a pivotal role in the clinical development of gene therapy programs, overseeing strategic planning, execution, and management of clinical trials.

Salary

Base: $156,000 - $288,200; Bonus/Equity: Company bonus; Benefits: Comprehensive benefit program including 401(k), pension, vacation, medical, dental, vision, life insurance, time off, well-being benefits

Skills & Requirements

Must-have

  • Gene therapy clinical development
  • Clinical trial strategy and execution
  • Regulatory compliance (ICH, GCP)
  • Cross-functional collaboration
  • Key opinion leader engagement

Nice-to-have

  • Ophthalmology (retina) experience
  • Rare diseases expertise
  • Strong relationships with KOLs
  • Philanthropy and volunteerism

Key Requirements

  • Advanced degree in life sciences (PhD, PharmD)
  • 8+ years clinical research experience
  • Experience designing, managing, executing clinical trials
  • In-depth knowledge of regulatory requirements (FDA, EMA, ICH/GCP)
  • Prior experience with IND and BLA/NDA submissions

Work Rights

Not specified

Tailored Resume

Cover Letter