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Immunovant · 2 weeks ago

Senior Vice President, Clinical Development

United States

Full-time

Onsite

Director/Executive

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Senior Vice President, Clinical Development will lead all development programs and provide medical oversight for clinical studies, ensuring timely execution of deliverables in collaboration with internal and external partners.

BiopharmaBiotechnologyPharmaceutical

Hiring Manager

Mohammad Ouranus

Responsibilities

Provide clinical scientific leadership for the clinical development organization

Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc

Provide medical safety oversight for Immunovant’s development programs

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

Qualification

Clinical trial designMedical oversightRegulatory submissionsImmunology experienceAnalytical skillsStrategic planningCross-functional collaborationTeamworkCommunication skillsAttention to detail

Required

Leadership experience in early to late-stage development in an industry (Biotech 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)

Ability to thrive in a fast-paced environment

Excellence in verbal and written communication, teamwork, and collaboration is a must

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

MD, DO, or non-US equivalent of MD degree

Domestic or international travel is required (20%)