Clinical Development Associate Medical Director-cystic Fibrosis

Vrtx

Boston, MA, United States
Base: $204,000 - $306,000; bonus/equity: eligible ...
On-site
Clinical trial protocol development
Investigator's brochure creation
Clinical development plan contribution
The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting

Job Summary

  • The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting.
  • This role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity.
  • The incumbent may participate in other projects to support the clinical development program and is eligible for an annual bonus and annual equity awards.

Matching Summary

The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting.

Salary

Base: $204,000 - $306,000; Bonus/Equity: Eligible for annual bonus and annual equity awards; Benefits: Market-leading benefits including paid time off, educational assistance, 401(k), and more.

Skills & Requirements

Must-have

  • Clinical trial protocol development
  • Investigator's Brochure creation
  • Clinical Development Plan contribution
  • Study Execution Team participation
  • Regulatory submission document preparation
  • Scientific and clinical input to study documents
  • Liaison between Clinical Development and internal groups
  • External medical personnel representation

Nice-to-have

  • Global clinical research experience
  • Experience interacting with regulatory authorities
  • Familiarity with analysis of research data
  • Working familiarity with biostatistics
  • Working familiarity with pharmacology and pharmacokinetics
  • International standards for Good Clinical Practice (GCP)
  • Clinical study design expertise
  • Ethics committee/Institutional Review Board review experience
  • Preparation of manuscripts
  • Abstract/poster preparation
  • Oral presentation skills
  • Overall drug/device clinical development knowledge

Key Requirements

  • MD, DO or equivalent ex-US medical degree
  • 8 years of basic or clinical research experience
  • Board certification/eligibility in a relevant medical specialty highly desired

Work Rights

Not specified

Tailored Resume

Cover Letter