Senior Medical Director, Trial Physician – Neurology

• Provide clear medical leadership to study teams in collaboration with cross-functional team members
• Create clinical trial protocols using the latest scientific information
• Contribute to site selection and review and approval of study protocols and amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents
• Perform real-time medical monitoring of clinical studies
• Ensure medical validity of primary endpoints and study subject safety
• Identify, escalate, and correct medical issues in consultation with the Global Medical Indication Lead
• Interpret clinical trial data for regulatory documents, manuscripts, and publications
• Serve as medical point of contact for internal and external stakeholders
• Interact with investigators and answer IRB and Health Authority questions
• Prepare and present materials to study executive and independent safety committees when applicable
• Provide medical training to site staff and CRA training in new indications
• Ensure medical compliance by applying relevant SOPs and GCP
• Collaborate with cross-functional study team members to clarify medical risks, issues, and results
• Occasional drives to site locations and domestic/international travel
• Work independently, plan schedules, manage variable tasks, and meet goals

• Must be legally authorized to work in North America without sponsorship
• Must be located in EST time zone
• Must be able to pass a comprehensive background check, including drug screening where applicable
• Medical Doctor or equivalent degree required
• Board certification(s) preferred
• Specialty education, such as residency/fellowship, required in neurology
• Patient treatment and/or research experience accompanying specialty education
• 1-3 years of industry experience required in clinical development within a Pharmaceutical, Biotech, or CRO organization
• Expertise in neuromuscular diseases highly preferred
• Excellent written and spoken English
• Ability to travel
• Understanding and experience with NDA submission process
• Understanding of regulatory guidelines for adverse event reporting
• Proven interpersonal skills to lead a study team and exercise judgment regarding escalation of issues
• Proactive problem-solving and negotiation skills
• Strong communication and collaboration skills in a global, cross-functional, matrix organization
• Ability to use a variety of computer software
• Ability to work independently, multitask, perform under stress, and maintain intense concentration
• Regular and consistent attendance

• Benefit eligible
• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture
• Travel in a 10-20% range (international may be required)