At Roivant, we are passionate about discovering & developing new drugs to impact patients lives. Since its inception in 2014, Roivant has launched over 20 portfolio companies (Vants), overseen 5 successful IPOs, established a $3B partnership with a global pharma, built a pipeline of over 40 assets across various modalities & therapeutic areas, & delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery & expanding its existing development engine to become the worlds leading 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.
Roivant Sciences is seeking a Nonclinical Senior Manager/Associate Director within the Research & Development team. The successful candidate will be responsible for the design, initiation, execution, & reporting of externally placed in vitro & in vivo studies. The candidate will be responsible for identifying laboratories (academic or CRO) to conduct needed studies & for establishing study budget & timelines. The candidate will qualify necessary sites & serve as Study Monitor. In collaboration with the Nonclinical Functional Heads will conduct due diligence and/or provide oversight to preclinical pharmacology & toxicology studies. The incumbent will represent the Nonclinical function on internal project team meetings.
- Design, execute, monitor, & interpret nonclinical studies for advancing candidates to global registration
- Develop & take ownership of studies, timelines, & budgets to drive programs to value inflection points for diverse assets at various stages of development
- Interface with contract research organizations (CROs) to request quotes for selection of testing labs & serve as Study Monitor
- Conduct detailed technical evaluation of non-GLP & GLP toxicology, DMPK, & pharmacology studies in support of Roivant pipeline assets, as well as assist in due diligence efforts. Identify gaps in development plan(s) & establish timelines & budget for a comprehensive development plan
- In collaboration with the Nonclinical Functional Heads develop nonclinical strategies for global registration
- Provide SME support relevant to background experience within Roivant as needed
- Participate in the scope-creation, execution, & oversight of Strategic Research Agreements with external collaborators
- Provide oversight to external consultants in the nonclinical area, as needed
- MSc or PhD in relevant biological sciences (Toxicology, Pharmacology, Drug Metabolism, etc.) or DVM
- 5+ years pharmaceutical or CRO industry experience
- Industrial experience in conducting & monitoring studies under GLP regulations
- Knowledge of drug development & understanding of life cycle management concepts & interdependencies with the overall development process
- Immunology and/or bioassay experience in nonclinical aspects of biologic/antibody, protein/peptide, or small molecule development is a plus
- Excellent written & oral communication skills
- Proven ability to independently manage multiple projects/tasks
- Ability to travel to CRO partners (as dictated by specific study needs), & New York main office (typically quarterly), on an as-needed basis (up to 25% of time).