Location: Roivant Sciences, Inc., 151 West 42nd Street, 15th Floor, New York, NY 10036
At Roivant, we are passionate about discovering and 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 and therapeutic areas, and delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery and expanding its existing development engine to become the world’s leading tech-enabled pharmaceutical company
As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods 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.
Roivant is seeking an experienced toxicologist to join our growing R&D organization.
Reporting to the Senior Director/Head of Toxicology, this Associate Director of
Toxicology position will involve designing and overseeing nonclinical safety assessment
programs for a diverse set of drug candidates spanning several modalities and
therapeutic areas, developing study protocols and reports, and interpreting data from
various studies. The candidate will also be responsible for writing nonclinical sections of
regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator
Brochures), risk assessment documents, and responses to regulatory questions.
- Design toxicology and safety pharmacology studies to support research and development programs
- Serve as a study monitor: review study protocols, attend meetings with CROs regularly to ensure integrity and quality of the study, critically review study reports and interpret the data.
- Prepare nonclinical sections of regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator Brochures) and interacts with regulatory authorities as needed
- Attend program teams meetings
- Participate in multi-disciplinary drug development team efforts, and attend program teams meetings
- Communicate and interact with functional areas including translational research, regulatory affair, clinical development, CMC, etc.
- PhD in toxicology or related field
- Board Certification in Toxicology is desirable
- More than 8 years’ relevant experience in industry conducting biologics and pharmaceutical research and development in large molecules and small molecules
- Familiar with ICH and FDA regulatory guidance documents for nonclinical drug development
- IND experience is required, BLA or NDA experience desired.
- Strong organizational skills and ability to manage multiple assignments
- Excellent written and verbal communication skills
- Experience at CRO is a plus
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.