VP, Clinical Development

October 13

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Roivant Sciences

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Description

• Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. • Roivant is seeking a physician to lead clinical trials for one or more of their development programs in Autoimmune Diseases. • The VP, Clinical Development will be the primary point person for medical oversight of clinical studies with responsibilities to include clinical trial design, feasibility assessment, protocol development, Sponsor medical monitoring, review and interpretation of clinical trial data, drafting key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. • This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners. • 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 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, BOD meetings, etc. • Develop and maintain strong, collaborative relationships with the broader organization. • Represent Roivant externally to trial site Investigators, KOLs, other stakeholders.

Requirements

• MD, DO, or non-US equivalent of MD degree with completion of residency in Internal Medicine or equivalent. • Minimum 5 years of experience at the Medical Director or Senior Medical Director level 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 in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs). • Prior late phase clinical trial experience in autoimmune disorders is desirable. • Board certification in Rheumatology is 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 is desirable.