Contract Medical Director

Milestone Pharmaceuticals is looking for a long-term, remote Contract Medical Director to integrate into our Medical team and play a key role in our Phase 3 clinical-stage program, focused on the development and commercialization of etripamil, a novel treatment of cardiovascular indications. The Medical Director will perform medical monitoring activities and will be co-responsible with the Clinical Trial Manager for executing these activities related to the Clinical Research projects.

In collaboration with Clinical Research Physicians, Clinical Biostatistician, and Clinical Data Manager, Quality Trial Manager and CROs. The successful candidate will:

  • Provide medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, concomitant medications, and general medical-related study issues
  • Respond to safety questions from the site or local IRB/IEC
  • Perform Local Adverse Event review and follow-up with the Investigator for additional information as needed
  • Review laboratory alerts, ECGs, Holters, and coordinate appropriate follow-up with study site and outside partners
  • Give input or preparation of protocols, protocol amendments, and informed consent forms
  • Conduct a periodic medical review of the Tables and Listings, and the Clinical Study Reports
  • Preview coding listings, lab reports, and subject profiles
  • Conduct medical training for the project team concerning study design and procedures
  • Provide medical input to study plans (monitoring plan, data management plan, statistical analysis plan)
  • Ensure all protocol inquiries and answers are documented
  • Attend and participate in Investigator Meetings
  • Review study reports, prepare and/or review subject narratives and periodic safety reports
  • Visit sites, if medical supervision is required, and conduct site audits

Education, Background, Knowledge and Skills

  • MD is required – Cardiologist is preferred
  • At least three years of biopharmaceutical, or relevant CRO, or consulting experience
  • Clinical Research: Experience and knowledge regarding clinical research protocols, and strong GCP knowledge
  • Clinical Development: Expertise and demonstrated ability to ensure high quality in the design, development, execution, clinical interpretation and reporting of clinical studies
  • Clinical Judgment: A demonstrated and proven track record of effectively applying medical expertise to make good clinical decisions in accordance with appropriate SOPs
  • Clinical Data Stewardship: A demonstrated understanding of the critical importance of rigorous data generation and disciplined stewardship of the data
  • Teamwork: Able to work as team member and team leader as appropriate. Able to adjust behavior to different circumstances and culture. Able to work in matrix organization
  • Good knowledge of Microsoft Excel and Word
  • Languages: English
  • Travel approximately 10%- 20%
  • Able to commit to a long-term contract 12+ month contract working 30-40 hours per week

*This is a remote position. Candidates who live on the East Coast or in Canada are preferred. However, this position can be filled by someone on the West Coast or in Europe. All qualified candidates are encouraged to apply and will be considered.

Milestone Pharmaceuticals is an equal opportunity employer and does not discriminate on any basis

Disclaimer: The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, but rather are intended only to describe the general nature of the position.