Director, Translational Sciences and Immunology

At Roivant, we are passionate about discovering and developing new drugs to impact patients’ lives. Since our inception in 2014, we’ve 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.

Our goal is to improve human health by rapidly discovering, developing and delivering innovative medicines and technologies to all patients. Our success is predicated on attracting and retaining top talent, generating new ideas and promoting an open and collaborative culture.

We embrace diversity across all dimensions and levels of the organization and we strive to ensure every employee is supported in reaching their full potential. We hire motivated people with diverse backgrounds, identities, experiences and skillsets. We are committed to fostering an inclusive culture where all employees feel valued, respected and empowered to create value for patients.

To learn more about our story and company culture, please visit us at https://roivant.com/

Location: Remote

Position Summary:

Roivant Sciences, Inc. is seeking an immunologist at the Director level within the Research and Development team. The successful candidate will be responsible for the conduct of diligence reviews of new potential assets along with the support of active development programs for assets at Roivant and its affiliates (“Vants”).

Responsibilities entail planning and oversight of in vitro and in vivo preclinical pharmacology studies in support of Roivant’s diverse pipeline of assets in active development and review of primary and secondary pharmacology, biology, and mechanistic aspects of programs undergoing due diligence. As a preclinical pharmacology subject matter expert, the successful candidate will also direct biomarker and translational strategies, bridging preclinical models and clinical proof of concept.

This role will represent the Nonclinical Development area on internal project team meetings and would be expected to draft/review/edit preclinical pharmacology and biomarker sections in regulatory documents for pre-IND, IND, EOP2, NDA/BLA filings along with investigator brochures and briefing books. 

Key Responsibilities:

• Plan, execute, and monitor non-GLP preclinical pharmacology studies in partnership with CROs (contract research organizations)
• Develop and implement biomarker strategy (e.g., genetic, genomic, proteomic, flow cytometry, immunohistochemistry) for assets in late-stage preclinical development transitioning to first in human studies
• Elucidate target engagement and therapeutically relevant exposure from diligence materials as well as be able to design/conduct studies to enable the same
• Conduct due diligence reviews and develop gap assessment and risk mitigation plans for new assets/programs and contribute to the development of strategies for global registration in diverse therapeutic areas
• Work closely with other functions (Nonclinical, Clinical, Regulatory) to support programs in active development toward value inflection points (i.e., FIH, POC, registration) at Roivant and affiliated Vants
• Coordinate with internal bioanalysis group to deliver methods and execute sample testing
• Represent Nonclinical Development and provide subject matter expertise across multiple project teams and broad pharmaceutical modalities
• Prepare or review pharmacology and biomarker-relevant parts of clinical protocols, clinical study reports, applicable regulatory documents, and publications
• Interact with regulatory authorities (preparation of documents, respond to request for information queries, and attend meetings with Health Authorities, as needed)
• Identify and provide oversight to external consultants in the nonclinical area, based on project-specific needs

Requirements:

• MSc or PhD in relevant biological sciences (Immunology, Pharmacology, Immuno-oncology)
• 7+ years pharmaceutical or CRO industry experience

• Immunological, immunomodulatory, and/or immuno-oncology experience, i.e., experience in conducting preclinical oncology/pharmacology studies, a functional understanding of relevant disease models, and demonstrated expertise in immunological mechanisms of action is a plus
• Integrated view of drug development and the position of preclinical pharmacology within the broader pharmaceutical development landscape
• Excellent written and oral communication skills
• Proven ability to independently manage multiple projects/tasks
• Experience writing the non-clinical portions of regulatory documents; previous interactions with regulatory agencies
• Excellent analytical sills with strong attention to detail, takes pride in high quality work
• High ethical standards
• Ability to travel to CRO partners (as dictated by specific study needs), and New York main office (at least quarterly), on an as-needed basis (up to 25% of time). 

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.