Senior Vice President, Clinical Development

Immunovant

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $1 - $2 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Lead all of Immunovant’s development programs
  • 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

Requirements

  • 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)
  • Prior late phase clinical trial experience in immunology, autoimmune or other rare diseases within the immunology/inflammation space is desirable
  • 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. Prior interactions with FDA and EMA regulatory agencies would be desirable
  • Domestic or international travel is required (20%)
Benefits
  • Unlimited paid time off
  • Parental leave
  • Full range of medical, dental, vision benefits
  • Equity and other forms of compensation based on job-related knowledge, skills, and experience

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial designclinical protocol writingsafety data analysisregulatory submissionsmanuscript writingbiostatisticspharmacovigilanceclinical operationsimmunologyautoimmune diseases
Soft skills
leadershipteamworkcollaborationcommunicationattention to detailproblem-solvingstrategic planningtime managementinterpersonal skillsadaptability