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. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; 10 consecutive positive phase 3 trials; 6 FDA approvals; >10$B in global pharma partnerships and proceeds; expanding pipeline of assets across various modalities and therapeutic areas; successful commercial launch of VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company. As the core engine for innovation and development the Roivant R&D team is responsible for: 1) integrating computational and medicinal chemistry methods with clinical and translational strategies in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio. Position Summary 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 and rare diseases. 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 need
Skills, Qualifications, and 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.
- Advanced knowledge of immunology and inflammation is preferred.
Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or Roivant Sciences, affiliated employees, or any of our subsidiary companies.