|
|
Position:
Director, Translational Sciences and Immunology
Employer:
Roivant Sciences
Description:
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
Qualifications/Experience:
- 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).
Location:
Remote
Contact:
https://boards.greenhouse.io/roivantsciences/jobs/4545747
Post Date:
10/5/2022 12:00:00 AM
|
|
Ads (in random order)
Submit a Text Ad ($250 for 2 months)
Lena Biosciences
Predictive toxicology. Mitochondrial toxicity in a drug metabolism-competent model with active transporters. Intrinsic & idiosyncratic DILI.
|
Alturas Analytics, Inc.
Expert Regulated & Non-Regulated LC-MS, GC-MS bioanalytical & PK/TK analysis of small & large molecules in any matrix. Discovery through phase IV.
|
Submit a Text Ad
|