Clinical Trial Physician - Neuromuscular

About the role

Provides clear medical leadership in the Study team, working in close collaboration with other members of this cross-functional team to deliver reliable, high-quality study data within time and budget.

Responsibilities

• Provide medical leadership to study teams, including creating clinical trial protocols while implementing the latest scientific information.
• Contribute to site selection, review, and approval of study protocols, amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions, and other clinical documents required for trial conduct.
• Perform real-time medical monitoring of clinical studies to ensure medical validity of primary endpoints and subject safety, identifying and addressing medical issues early.
• Proactively escalate and correct issues in consultation with the Global Medical Indication Lead.
• Interpret clinical trial data for regulatory documents (e.g., CSRs, INDs, Annual Reports, NDAs, MAAs), manuscripts, and other publications in consultation with the Indication Lead.
• Serve as the medical point of contact for internal and external stakeholders, including interacting with investigators, answering questions from IRBs and Health Authorities, and preparing materials for study executives and independent safety committees.
• Provide medical training for site staff at Investigator meetings and train CRAs in new indications.
• Ensure study compliance for all medical aspects by understanding and applying relevant SOPs and GCP.
• Collaborate closely with cross-functional study team members to ensure medical risks, issues, and results are transparent to all involved.
• If multiple physicians work on a protocol, a primus inter pares will be appointed to harmonize answers to questions from sites, IRBs, regulatory authorities, eligibility, and protocol deviation decisions.

Requirements

• Medical Doctor; relevant specialty education preferred (e.g., neurology, hematology, dermatology, immunology, rheumatology, internal medicine, pediatrics).
• Some experience in the pharmaceutical industry preferred.
• Excellent written and spoken English is required, along with the ability to travel.

Skills

• Proven interpersonal skills to lead a study team, recognize individual expert competencies, provide medical advice, and exercise judgment on escalation needs.
• Proactive problem solver with negotiation skills, sensitive to cultural needs in a global organization.
• Strong communication skills to ensure close collaboration with cross-functional team members, maintaining transparency of study plans, risks, issues, and results.
• Ability to gather decision information, negotiate, and communicate decisions and actions effectively in a matrix structure.