Executive Medical Director – Clinical Development

🕒 May 7

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Immunovant

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

📋 Description

• 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.

🏖️ Benefits

• full range of medical, dental, vision, 401k, and other benefits • unlimited paid time off • parental leave