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Director/Senior Director Clinical Development
3 months ago
The Medical Director/Senior Director will join the Clinical Development group and provide clinical scientific leadership for programs including direct responsibility for clinical development strategy and execution of clinical trials, with a focus in immunology, rare diseases and oncology. The optimal candidate will have the desire to proactively participate within a cross-functional team of internal clinical, regulatory, scientific and operational colleagues and have the ability to interact with external experts, investigators and government agencies. This role is instrumental in supporting the growth of Roivant’s portfolio and subsequent generation of new portfolio companies.
Responsibilities
Hands-on responsibility designing and executing clinical trials, in addition to developing and implementing clinical strategies. 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 (Biostatistics, Regulatory, Clinical Operations etc.) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s). Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements; may serve as a clinical representative for key regulatory discussions. Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, accrual, and safety data review. Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory/manufacturing strategy into global product development strategy Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Ensures 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 (e.g. Investigator Meetings, SIVs, Advisory Boards, Steering Committee Meetings, etc.) 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. Manage direct reports based on needSkills, Qualifications, and Requirements
MD, MD/PhD, or PharmD 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. Advanced knowledge of immunology and inflammation or oncology is preferred.