Remote Director/Senior Director Clinical Development

Summary

The Medical Director/Senior Director will join the Clinical Development group at Roivant Sciences and provide clinical scientific leadership for programs focusing on immunology, rare diseases, and oncology. The role involves designing and executing clinical trials, leading project scientists, working with functional partners, and ensuring compliance with regulatory requirements.

Requirements

• MD or MD/PhD
• 5+ years clinical development experience in a pharmaceutical/biotech company and ideally 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
• Can integrate precision medicine and partner to develop a robust translational medicine strategy
• Technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies
• Proven ability to work independently and to lead a multidisciplinary trial team in a complex matrix environment. Experience in developing effective relationships with key investigators
• Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process

Responsibilities

• Hands-on responsibility for designing and executing clinical trials
• Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program
• Work closely with functional partners to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s)
• Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies
• Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research
• Work with external collaborators, including CROs and other external academic or industry partners
• Support the creation of and/or review of clinical slides for internal and external meetings
• Assist or lead in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc
• Evaluate medical rationale in new potential assets or indications, discuss proof-of-concept and registration trial designs with external experts
• May review/co-author medical publications emerging from clinical trial results

Preferred Qualifications

Advanced knowledge of immunology and inflammation or oncology is preferred