Description
Kinevant Sciences, a wholly-owned subsidiary of Roivant, is focused on developing new therapies for rare auto-immune diseases, initially targeting sarcoidosis with an anti-GM-CSF monoclonal antibody (namilumab). The Company has recently initiated a Ph 2 clinical trial in pulmonary sarcoidosis. Sarcoidosis is a multi-organ autoimmune disease with poor treatment options that affects up to 200,000 people in the U.S. The long-term vision for Kinevant is to successfully develop and commercialize namilumab for sarcoidosis and potentially other inflammatory orphan diseases, as well as in-license other promising drug candidates for orphan autoimmune and inflammatory diseases.
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; >$8B in global pharma deals and partnerships; 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.
Position Summary
In this role you will work as a thought partner and right hand to the CEO and CMO of Kinevant providing strategic program leadership and operational management initially for namilumab’s development. The scope will initially focus on the execution of a global Ph 2 clinical trial in pulmonary sarcoidosis with expansion potentially to other indications for this program or to other programs.
Responsibilities
- Lead the program management function, developing and adding competencies as required, ensuring consistency and coordination across programs and functions
- Provide strategic leadership to drive and ensure a comprehensive development strategy at Kinevant, integrating inputs across functions and in collaboration with relevant internal and external stakeholders
- Accountable for the operational feasibility of development plans, and ensure programs are tracking to timelines and fit into the broader strategy of the organization, making tradeoffs as appropriate
- Drive the execution of programs, translating proposed strategies into operational plans, including timelines, budgets, and resource requirements; highlight key milestones and risks to CEO/CMO and team members as needed
- Drive operational excellence activities ensuring that high operational standards are maintained across programs, including program metrics, communication platforms, and process improvement initiatives
Requirements
- 15+ years’ experience managing cross-functional drug development teams or managing clinical operations for multiple clinical trials
- Drug development knowledge across a broad range of functions and therapeutic areas including both early and late stage development
- Knowledge of relevant pharmaceutical quality and regulatory standards requirements
- Proven track record of project and/or operational support for successful IND, CTA and BLA regulatory submissions
- Track record of creating strategies, long-term planning and managing integrated timelines and resources
- Intellectual agility - able to pivot based on shifting priorities and balance multiple projects seamlessly in a fast-paced environment
- Natural collaborator who enjoys working on a cross-functional team
- Demonstrated leadership, communication, organization, and critical thinking/problem-solving skills
- PhD or advanced scientific degree is strongly preferred
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.
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