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 Ph 2 clinical trials in pulmonary sarcoidosis and cardiac 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.
The Associate Director of Program Management supports cross-functional teams to ensure projects meet objectives and are delivered on time. Under the general supervision of the VP of Program Management, the Associate Director of Program Management is primarily responsible for:
- Providing technical and operational support to the framework, processes and tools that enables the project team(s) to effectively plan, execute and report on the full lifecycle of Kinevant’s Phase I, II and/or III clinical trials from protocol development and study start-up to study close-out and Clinical Study Report as well as through regulatory submissions
- Working with the VP of Program Management to manage project team meetings, deliver minutes and monitor the resolution of actions
- Working in partnership with functional leaders to independently develop and maintain the timelines, risk register, and budget for the cross-functional drug development project(s)/program(s)
- Tracking progress toward milestones and communicating potential risks and conflicts
- Identifying potential deviations via routine communications and timeline reports
- Applying project management expertise to other internal operations as necessary
The Associate Director of Program Management supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOP) as appropriate. The ideal candidate will have a scientific background and familiarity with drug development. In this highly visible role, they will be able to routinely flex between scientific / technical details and big-picture planning. They will have or be able to quickly develop a breadth and depth of expertise in drug development and will partner closely with many internal and external stakeholders.
- Help facilitate project team meetings comprised of internal and external functional representatives including but not limited to preclinical development, clinical development and operations, regulatory affairs, quality, pharmaceutical development and manufacturing, and finance.
- Work in partnership with functional leaders, ensures ongoing alignment to project team goals and objectives by creating and maintaining timelines and tracking activities to ensure alignment with target dates; tracks and highlights issues and provides timely updates to the project team on off-track activities; ensures efficient and timely communication between/across functions and senior management; develops scenarios and solve problems.
- Support in partnership with Clinical Operations the execution of one or more clinical trial(s) by developing and actively managing comprehensive, integrated, and accurate clinical trial project plans and associated timelines; identifies critical path deliverables; identifies risks/challenges and assist with the development and implementation of risk mitigation plans.
- Partner with functional leaders and Finance to support management of financial aspects of program(s) including tracking to budget and ensuring effective use of resources.
- Manage the project hub SharePoint team site and collaborative platforms
- Assist with identifying, implementing, and communicating across projects best practices related to the development, initiation, planning, execution, control and closing of pre-clinical and clinical studies.
- Where applicable for the program, help the VP of Program Management or other relevant Kinevant functional leaders in managing strategic alliances with biotechnology, patient advocacy groups and academic institutions; assists and coordinate with Legal and functional heads to establish confidential document agreements and non-disclosure agreements.
- Reinforce and support team operating principles, best practices and team building to ensure effective and high-performing teams; consistently seeks ways to improve team performance.
- Perform other tasks and assignments as needed and specified by management.
Skills, Qualifications, and Requirements
- Master's degree in a scientific discipline and a minimum of 5 years of progressively responsible experience in clinical development or pharmaceutical research and development roles and a minimum of 3 years in a project management role in pharmaceutical, biotechnology, contract research organization or related environment OR equivalent experience and/or education.
- Experience across the clinical drug development process (Phase I or II or III) including interactions with preclinical, clinical, technical operations, regulatory, CMC and commercial functions.
- Proficiency with Microsoft Office and project management tools such as Microsoft Project, Microsoft Teams, and SharePoint; experience with OnePager is a plus
- Experience in biologics and immunology therapeutic area is a plus
- Excellent planning, organizational and time management skills including the ability to support and prioritize multiple projects.
- Strong interpersonal skills with ability to lead, engage, focus, negotiate, and resolve conflict internally and externally across multiple stakeholders to identify and resolve key project issues
- Strong analytical, organizational, and problem-solving skills and the ability to adapt to changing priorities and deadlines; willingness to challenge the status quo.
- Combines attention to detail with big-picture strategic perspective.
- Navigates complexity and ambiguity to adapt to evolving priorities in a fast-paced environment. Demonstrated ability to work proactively, independently, and collaboratively in a dynamic team environment, set priorities and drive to results.
- Strong sense of urgency and able to re-think and re-imagine every step.
- Integrates multiple viewpoints and builds alignment.
- Excellent written and verbal communications skills; including presentation and facilitation.
Kinevant 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.