Executive Medical Director, Clinical Development

The Role:

The Clinical Development Leader – Neurology is a key role within Immunovant’s Neurology portfolio. This Clinical Development Leader will lead clinical trials for one or more of Immunovant’s development programs in neurology. Specifically, this role will be directly responsible for Immunovant’s ongoing major study for IMVT-1402 in CIDP.

For this critical position, the Clinical Development Leader will be the primary point person for medical oversight of clinical studies with responsibilities to include clinical trial design, site feasibility assessment, protocol development, clinical trial enrollment, sponsor medical monitoring, review, and interpretation of clinical trial data, drafting key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.

The successful candidate is driven, curious, patient focused, collaborative, with a bold ambition to contribute to Immunovant’s mission to enable normal lives for people living with autoimmune diseases.

Key Responsibilities: 

• Provide clinical scientific leadership for the clinical study team.
• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
• Provide medical safety oversight of CRO medical monitors.
• Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.
• Collaborate closely with partners in Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Lead the design and writing of clinical protocols and associated clinical documents.
• Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
• Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
• Assume primary responsibility for presentations related to clinical trial data and assist in the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
• Contribute to the writing of manuscripts and publications.
• Comply with Immunovant's SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board meetings, IMVT BOD meetings, etc.
• Develop and maintain strong, collaborative relationships with the broader Immunovant organization.
• Represent Immunovant externally and build successful relationships with multiple stakeholders including trial site Investigators, KOLs, and others.
• Excellence in verbal and written communication, teamwork, and collaboration is a must.

Requirements:

• A minimum of 8 years’ experience in early to late-stage development in an industry (CRO and/or Pharma) setting.
• Proven ability to: Plan and conduct clinical trials.
• Deliver high-quality results within established timelines.
• Demonstrated track record in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).
• Prior late phase clinical trial experience in neurology is highly desirable.
• Ability to thrive in a fast-paced environment.
• Proven ability to successfully manage multiple tasks and prioritize accordingly.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Excellent analytical, problem-solving, and strategic planning skills.
• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
• Exceptional written and oral communication skills to meet the needs of varied audiences.
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies would be desirable.

Education

• MD, DO, or non-US equivalent of MD degree.
• Board certification in Neurology is strongly preferred.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (20%)