Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities & therapeutic areas; 8 successful phase 3 readouts since 2019. Building upon this track record of establishing a robust pipeline through in-licensing & acquisition of novel assets & technology platforms, Roivant is currently building new capabilities in drug discovery & expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.
As the centralized engine for innovation & development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational & medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology & rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale & initial development strategy for in-licensing opportunities; 3) providing tactical & strategic R&D support to stand up new portfolio companies (Vants) & advance development efforts across the portfolio.
Position Title: Medical Director / Senior Director, Clinical Development
Position Location: New York, NY (location arrangements are flexible, however)
Manager Title: Head of Development
The Medical Director will join the Clinical Development group & provide clinical scientific leadership for programs including direct responsibility for clinical development strategy & execution of clinical trials, with a focus in oncology. The optimal candidate will have the desire to proactively participate within a cross-functional team of internal clinical, regulatory, scientific & operational colleagues & have the ability to interact with external experts, investigators & government agencies. This role is instrumental in supporting the growth of Roivants portfolio & subsequent generation of new portfolio companies.
- Hands-on responsibility designing & executing clinical trials, in addition to developing & implementing clinical strategies
- Lead the project scientists, ensuring appropriate training, mentoring, & 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 & strategic approach to flawless execution & systematic oversight of study protocol(s)
- Responsible for understanding the regulatory requirements related to the clinical studies & global drug development & accountable for complying with those requirements;
- Serve as the clinical representative to lead key regulatory discussions
- Serve as team lead for one or more project teams
- Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, accrual, & safety data review.
- Primary point of contact for medical inquiries from sites, CRO & site monitors; answer or triage questions as appropriate integration of clinical/regulatory/manufacturing strategy into global product development strategy
- Responsible for assessment & reporting of serious adverse events per corporate policy & regulations for those protocols on which assigned
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures & to all other quality standards in conducting research
Skills, Qualifications, & Requirements:
- MD (MD/PhD preferred)
- 7+ years clinical oncology experience in a pharmaceutical/biotech company
- Experience designing & executing first-in-human through registration-enabling clinical programs
- Technical, operational & managerial experience in planning, executing, reporting & publishing clinical studies.
- Proven ability to work independently & 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, & global clinical development process.
- Advanced knowledge of oncology is required