Autoinjector Lead

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and 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); 6 FDA approved medicines; 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 8 consecutive positive phase 3 readouts since 2019.  Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the first large 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. 

Position Summary

Roivant is seeking an expert in injectable device development to lead device evaluation, process development, product integration, and manufacturing of patient-centered injectable drug products. A key focus area would be on the successful development of drug/device combination products for RVT-3101. RVT-3101 is a potential first in class, fully human monoclonal antibody currently in clinical development for Ulcerative Colitis and Crohn’s Disease. 

The position will work with the department head to assess appropriate device/drug product development and delivery strategies via internal and external partnerships, managing the budget and internal resources for the development of clinical and commercial phase drug products. The ideal candidate will also enable the development of phase-appropriate regulatory strategies and products.

Responsibilities

• Leads activities for the selection of an autoinjector device platform for RVT-3101, an injectable drug in development. Develops a strategy to evaluate and implement the chosen platform.
• Direct process development, product integration, and manufacturing of patient-centered, differentiated injectable drug products, with focus on RVT-3101.
• Progresses the development of RVT-3101 for delivery via an autoinjector and prefilled syringe. Direct work at CDMO’s to evaluate the product in pre-filled syringes and to develop and evaluate product performance in an autoinjector.
• Participates in developing drug product development and delivery strategies through internal/external partnerships as well as product integration into drug/device combination products.
• Manages manufacture of prefilled syringe drug product and auto-injector assembly. Lead process characterization and process validation studies for late-stage programs to enable robust commercial manufacturing processes.
• Leads development of CMC strategy to implement PFS/Auto-injector in a late stage development program. Provide subject matter expertise for regulatory interactions including inspections, audits and is accountable for the technical content of drug product sections of regulatory submissions.
• Work on drug product development strategies with key stakeholders in Research, Clinical Development, Regulatory Affairs, Quality, and Commercial organizations. 

Skills, Qualifications, and Requirements

• BS/MS/PhD or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline with relevant experience.
• Substantial years of injectable device development experience with 5+ years of experience leading device development for biologics.
• Experience in managing drug product and device development at external CDMO’s.
• Deep knowledge of development of autoinjector and pre-filled syringe drug-device combinations, biologics drug product manufacturing, aseptic processes, and knowledge of current regulatory guidelines and cGMP requirements is essential.
• Direct experience in preparing regulatory submissions including BLA/MAAs and engaging with regulatory inquiries is required.
• Experience in developing CMC strategy for development programs. Ability to manage timelines, budgets and integrated development plans.

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.