Remote Medical Director - Neurology Trials Lead

Regulatory Jobs; Lexington (MA); Remote; USD 205,000 - 265,000; Full time

Job summary

uniQure seeks a Medical Director to lead US-based clinical trials in neurology and rare diseases. You will oversee trial execution, safety, efficacy assessments, and regulatory interactions, collaborating with cross-functional teams and external partners.

You will engage with KOLs, investigators, and CROs, ensure FDA/GCP compliance, and contribute to regulatory submissions and medical writing. Travel to study sites and conferences is expected.

Qualifications

• MD with neurology board certification; 5+ years clinical trial experience.
• Experience leading Phase I/II trials in neurology or rare disease preferred.
• Willingness to travel to study sites and attend meetings.
• Strong written and verbal communication with regulatory authorities.

Responsibilities

• Lead and oversee clinical trials focused, ensuring adherence to regulatory and ethical standards.
• Collaborate with the clinical development team to support study design, implement, and monitor clinical trial protocols, with a focus on safety, efficacy, and regulatory compliance.
• Provide expert guidance on patient selection criteria, dosing regimens, and endpoints.
• Develop and maintain strong relationships with Key Opinion Leaders (KOLs), clinical investigators, study coordinators, and other stakeholders.
• Represent the company at scientific conferences, patient events and advisory boards.
• Oversee the monitoring of trial activities, including patient safety, adverse event reporting, and efficacy assessments.
• Support the study team in the review and interpretation of clinical trial data, providing insights and recommendations for trial progression.
• Collaborate with the Medical Safety and PV team to ensure timely reporting and resolution of safety issues.
• Ensure that all clinical trial activities comply with FDA regulations, GCP, and other regulatory requirements.
• Participate in the preparation of regulatory submissions, including protocol amendments and safety reports.
• Work with cross-functional teams to ensure successful trial execution; educate uniQure staff on epilepsy-related aspects and assessments.

Skills

MD with board certification

Neurology background

Clinical trial leadership

Regulatory knowledge

Excellent communication

Education

MD degree

Job description

uniQure seeks a Medical Director to lead US-based clinical trials in neurology and rare diseases. You will oversee trial execution, safety, efficacy assessments, and regulatory interactions, collaborating with cross-functional teams and external partners.

You will engage with KOLs, investigators, and CROs, ensure FDA/GCP compliance, and contribute to regulatory submissions and medical writing. Travel to study sites and conferences is expected.