Provide medical leadership for neurology clinical trials, with a focus on protocol development, real-time medical monitoring, and review of study documents to support patient safety and data quality. The role centers on clinical development work for studies in autoimmune disease, while also collaborating on regulatory materials, site interactions, and medical training for internal teams and investigators. This is a fully remote position with occasional domestic and international travel, and it requires close coordination with a cross-functional study team in a global biotech environment.
Key Responsibilities
- Provide medical leadership to study teams and help guide clinical trial strategy.
- Conduct real-time medical monitoring to assess endpoint validity and patient safety.
- Review and approve protocols, amendments, CSRs, ICFs, CRFs, and other trial documents.
- Contribute to site selection and support study execution from start to finish.
- Interpret clinical trial data for regulatory documents, manuscripts, and publications.
- Serve as medical contact for investigators, IRBs, health authorities, and internal stakeholders.
- Provide medical training to site staff and CRA teams as needed.
- Ensure compliance with SOPs, GCP, and applicable adverse event reporting and regulatory standards.
Required
- Medical Doctor or equivalent degree.
- Specialty training in neurology, such as residency or fellowship.
- 1-3 years of industry experience in clinical development within pharma, biotech, or CRO settings.
- Patient treatment and/or research experience in neurology.
- Ability to travel and work English fluently, written and spoken.
Preferred
- Board certification.
- Experience with pediatric neurology or neuromuscular diseases.
- Experience with NDA submission processes.
- Background in regulatory guidelines for adverse event reporting.
Benefits & Perks
- Fully remote work arrangement.
- Benefit eligibility.
- Travel supported at approximately 10-20%, including possible international travel.
- Healthcare coverage.
- Annual incentive plan bonus.
- Employee benefits package.
- Career and development prospects within an innovative organization.