Senior Medical Director, Trial Physician – Neurology

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Offer comprehensive medical leadership to study teams, ensuring the production of reliable, high-quality study data within designated timelines and budgets.

• Develop clinical trial protocols that incorporate the most recent scientific advancements.

• Participate in site selection and the review and approval of study protocols, amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and additional clinical documents.

• Perform real-time medical monitoring of clinical trials.

• Guarantee the medical validity of primary endpoints and the safety of study subjects.

• Identify, escalate, and resolve medical concerns in collaboration with the Global Medical Indication Lead.

• Analyze clinical trial data for regulatory documents, manuscripts, and various publications.

• Act as the medical liaison for both internal and external stakeholders.

• Communicate with investigators and respond to inquiries from IRBs and Health Authorities.

• Prepare and deliver presentations to study executives and independent safety committees as necessary.

• Provide medical training to site personnel during investigator meetings and CRA training for new indications.

• Ensure adherence to medical compliance by understanding and implementing relevant SOPs and GCP guidelines.

• Collaborate with cross-functional team members to clarify medical risks, issues, and results.

• Engage with a global, client-focused biotech organization that is dedicated to developing treatments for autoimmune diseases.

• Occasionally travel to domestic and international study sites.

⛳️ Requirements

• A Medical Doctor or equivalent degree is mandatory.

• Board certification(s) are preferred.

• Specialty training, such as residency or fellowship, is required in neurology.

• Experience in patient treatment and/or research is essential.

• A minimum of 1–3 years of industry experience in clinical development within a Pharmaceutical, Biotech, or CRO organization is required.

• Expertise in neuromuscular diseases is highly desirable.

• Proficient written and verbal English communication skills are necessary.

• Willingness to travel is required.

• Familiarity with the NDA submission process is essential.

• Knowledge of regulatory guidelines for adverse event reporting is expected.

• Strong interpersonal skills to lead a study team and make judgments on issues that require immediate escalation.

• Proactive problem-solving and negotiation abilities are crucial.

• Excellent communication and collaboration skills within a cross-functional, matrixed organization are required.

• Must have legal authorization to work in North America without sponsorship.

• Capable of passing a comprehensive background check, including drug screening where applicable.

• Must reside in the EST time zone.

• Ability to access and utilize in-house and commercial computer software is required.

• Consistent and regular attendance is expected.

• Ability to work independently, multitask, perform under pressure, and maintain intense concentration is necessary.

• Must be able to perform physical activities, including occasional lifting and carrying of 15–20 lbs.

🏝️ Benefits

• Annual incentive plan bonus.

• Healthcare coverage.

• A variety of employee benefits.

• Opportunities for career and professional development.

• Fully remote work arrangement.

• Travel requirements range from 10–20%, including potential international travel.