About this role

Provides clear medical leadership in the Study team
working in close collaboration with the other members of this cross functional team
Provide medical leadership to the study teams, including creating clinical trial protocols
contribute to site selection
review and approval of study protocols and amendments
Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions
ensure medical validity of each individual primary endpoint as well study subject safety
Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
Collaborate with the cross functional study team members

Medical Doctor or equivalent degree required
Board certification(s) are preferred
Specialty education(e.g. residency/fellowship) required in rheumatology
This should be accompanied by patient treatment and/or research experience
1-3 years of industry experience preferred
Experience should be in clinical development in a Pharmaceutical, Biotech or CRO organization
Excellent English, both written and spoken is a must
Shown understanding and experience with NDA submission process
Shown understanding of regulatory guidelines for adverse event reporting
Proven interpersonal skills enabling to lead a study team
Pro-active problem solver with negotiation skills
Strong communication skills

Medical Director – Clinical Trial Physician, Rheumatology

Key skills