Senior Director, Clinical Development Scientist, Kinevant (Remote)

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 Location: Remote (location arrangements are flexible)

Position Summary   

The Clinical Development Scientist (CDS) provides input into a clinical study protocol/ development strategy and supports a clinical study team. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution.  This role will oversee high priority clinical programs by being an extension of the medical team (supporting medical monitoring, study plan development, interim analysis/review, etc.); wil lead clinical data review and the driving of protocol/amendment writing and interpretation; drive program(s) to completion with the ability to understand the science and data from a clinical perspective; and lead coordination of medical alignment and cross functional teams in preparation for strong presentation to KOLS and the BOD.

Responsibilities    

• Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical analyses plans and summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Liaising with other functions to enable quality clinical study By ensuring knowledge of the protocol. Implementing effective quality control procedures and monitoring their execution.
• Provide input to the study team for country and site feasibility
• Collaborate with the clinical study team in site identification and selection and assist with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
• Participate in Investigator meeting planning and execution and/or on-site initiation
• Monitor, clean, analyze, and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
• Support the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, within a therapeutic area.
• Liaise with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, and study essential Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
• Review and synthesize scientific literature and competitive intelligence to support study and program strategy
• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Support development of publications arising from studies and other relevant
• Provide support for business development activities, such as due diligence and research
• Where appropriate, serve as the SME for identification, translation, inclusion, implementation, and reporting related to liquid, tissue and/or imaging endpoints

Skills, Qualifications, and Requirements    

• Advanced scientific degree (M.S., D., Pharm D., MPH or similar degree) highly desirable.
• Understanding of general (and specific) therapeutic principles including therapeutic area
• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
• Familiar with scientific literature searches and weighing of quality peer reviewed data
• Ability to clearly communicate to internal and external stakeholders orally and in writing
• Basics of strategic tactical thinking.
• Strong written and oral presentation
• Fosters a collaborative work environment; has skills demonstrating leadership and ability to lead by
• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
• Engage in problem solving and non-linear thought, analysis, and systematic thinking.
• Required to travel domestically to company offsites held every quarter

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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