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: launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 8 successful phase 3 readouts since 2019. Traditionally, Roivant provides all the capital required for Vant operations until the Vant becomes a public company. Roivant attracts, retains, and motivates entrepreneurial company builders that have deep domain expertise with competitive compensation and benefits, including stock option grants in the Vant.
Position Summary
The Clinical Operations Manager will be responsible for front line management and oversight of clinical operations activities and ensuring timely and adequate documentation of the Vant’s clinical trial(s). This role includes oversight of monitoring activities, identifying and escalating ongoing risks and ensuring operational deliverables are documented.
Responsibilities
- eTMF Oversight
- Review and QC Clinical Monitoring trip reports to identify trends in CRA performance, site issues or deviations, and work with individual CRAs and/or the CRO to
- understand root causes for trends in data quality
- Monitor progress of identified findings through resolution
- Review On-Site Visit Tracker/CTMS Export (Site Management)
- Escalate findings to Operations Management or Quality as appropriate
- Update and compile clinical study metrics for review and escalation as appropriate
- Review prescreening Log Activities and drive sites to update documentation
- Oversee Temperature Excursions for Investigative Medicinal Product
- Coordinate and facilitate clinical document revisions (plans, memos, notes to file)
- Communicate and provide sponsor contact to study sites
- Participate in any training meetings and train CROs/vendor staff as required
- Perform User Acceptance Testing for EDC/PROs
- Provides support to Clin Operations team as needed
- CT.Gov/PRS submissions and updates
Skills, Qualifications, and Requirements
- Bachelor’s degree or equivalent in the life sciences or related field required.
- Experience in a small, fast-paced start up biotech is a plus
- Experience with CRO operations management
- Ability to travel to CRO partners (as dictated by specific study needs), and New York main office, on an as-needed basis
- Ability to deal with multiple priorities and aggressive timelines
- Proven ability to independently manage multiple projects/tasks
- Strong Oral and written communication skills
Kinevant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.
