Executive Medical Director, Clinical Development

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

📋 Description

• Provide clinical scientific leadership for the clinical study team.

• Offer medical leadership for cross-functional internal workstreams, including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, and more.

• Oversee medical safety in collaboration with CRO medical monitors.

• Partner with the pharmacovigilance department to analyze clinical trial safety data.

• Work closely with Clinical Operations to ensure accountability for clinical trial execution and timelines for key deliverables.

• Lead the design and drafting of clinical protocols and related clinical documents.

• Direct the writing of clinical and safety sections for key program documents, such as Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.

• Responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.

• Take primary responsibility for presentations related to clinical trial data and assist in preparing meeting abstracts, posters, and presentations concerning clinical trial data.

• Contribute to the writing of manuscripts and publications.

• Adhere to Immunovant's SOPs and comply with ICH, GCP, and relevant regulatory guidelines.

• Provide medical leadership during internal audits and regulatory inspections.

• Assist in preparing materials for Advisory Board meetings, IMVT BOD meetings, and other similar events.

• Foster and maintain strong, collaborative relationships within the broader Immunovant organization.

• Represent Immunovant externally and cultivate successful relationships with various stakeholders, including trial site Investigators, KOLs, and others.

• Exhibit excellence in verbal and written communication, teamwork, and collaboration.

⛳️ Requirements

• A minimum of 8 years of experience in early to late-stage development within an industry setting (CRO and/or Pharma).

• Proven capability to plan and conduct clinical trials.

• Deliver high-quality results within specified timelines.

• Demonstrated success in working effectively within cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).

• Prior experience in late-phase clinical trials in neurology is highly desirable.

• Ability to excel in a fast-paced environment.

• Proven track record of managing multiple tasks and prioritizing effectively.

• Strong attention to detail, an internal drive for high-quality work, and a sense of passion and urgency to achieve team and program objectives.

• Excellent analytical, problem-solving, and strategic planning skills.

• Strong interpersonal skills necessary for close collaboration with CROs, investigators, consultants, and team members across various functions.

• Exceptional written and verbal communication skills to cater to diverse audiences.

• Comprehensive understanding of FDA, EMA, ICH, and GCP guidelines; prior interactions with FDA and EMA regulatory agencies are desirable.

🏝️ Benefits

• A comprehensive range of medical, dental, vision, 401k, and additional benefits.

• Unlimited paid time off.

• Parental leave.