Clinical Development Director

4 weeks ago

New York, New York, United States Roivant Sciences Full time
Job Title: Clinical Development Director

The Clinical Development Director will play a key role in the Clinical Development group at Roivant Sciences, providing clinical scientific leadership for programs and direct responsibility for clinical development strategy and execution of clinical trials, with a focus on immunology and rare diseases.

Responsibilities:
  • Design and execute clinical trials, developing and implementing clinical strategies.
  • Lead project scientists, ensuring training, mentoring, and supervision across assigned studies.
  • Collaborate with functional partners to ensure integrated and strategic approach to flawless execution and systematic oversight of study protocols.
  • Understand regulatory requirements and ensure compliance, serving as a clinical representative for key regulatory discussions.
  • Assume medical responsibility for clinical trials, participating in real-time medical monitoring, patient eligibility assessment, study design questions, accrual, and safety data review.
  • Primary point of contact for medical inquiries from sites, CROs, and site monitors.
  • Report serious adverse events per corporate policy and regulations.
  • Ensure adherence to Good Clinical Practices, pharmacovigilance standards, and quality standards.
  • Work with external collaborators, including CROs and academic or industry partners.
  • Support the creation of clinical slides for internal and external meetings.
  • Author key clinical study documents, including protocols, clinical study reports, and regulatory authority briefing books.
  • Evaluate medical rationale in new potential assets or indications.
Requirements:
  • MD or MD/PhD degree.
  • 5+ years of clinical development experience in a pharmaceutical or biotech company, with 2+ years in a lead development role.
  • Experience designing and executing first-in-human through registration-enabling clinical programs.
  • Experience in both US and outside US (OUS) development preferred.
  • Technical, operational, and managerial experience in planning, executing, reporting, and publishing clinical studies.
  • Proven ability to work independently and lead a multidisciplinary trial team in a complex matrix environment.
  • Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process.

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