Senior Director, Clinical Development Scientist, Kinevant

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Kinevant Sciences and Roivant's Mission

Kinevant Sciences, under Roivant's umbrella, specialises in creating innovative treatments for rare autoimmune disorders, specifically sarcoidosis. They are progressing with a Phase 2 clinical trial for their anti-GM-CSF monoclonal antibody drug, namilumab. Sarcoidosis affects multiple organs and lacks adequate treatment options, impacting around 200,000 individuals in the U.S.

Roivant is dedicated to expediting the delivery of new medicines by addressing the traditional challenges of drug development such as high costs, risks, and lengthy timelines. Since 2014, Roivant has launched over 20 entities, secured 6 FDA approvals, accomplished 5 successful IPOs, and entered into partnerships worth over $8 billion. Their pipeline is rich with over 40 assets, and they have recorded 8 positive Phase 3 outcomes since 2019. Roivant is now focusing on new drug discovery and enhancing development methodologies with the ambition to become the premier tech-enabled pharmaceutical company.

Remote Position Opportunity

The opportunity is for a Clinical Development Scientist (CDS) role which involves remote work with flexible location arrangements. The CDS will work closely with clinical development physicians and the therapeutic area head, assisting with clinical study design and execution.

Main Responsibilities

Job responsibilities for the CDS position include:

• Preparation of clinical study documentation, such as protocols, charters, and statistical analysis plans.
• Ensuring quality clinical studies through effective protocols and quality control monitoring.
• Assisting in clinical study site selection, initiating studies, and developing essential study documents.
• Managing and reviewing safety and efficacy data, identifying trends, and ensuring proper follow-up.
• Clinical study design and execution, including investigator meetings and site initiations.
• Collaboration with external experts and clinical study teams for quality study execution and strategy formulation.
• Contributing to scientific literature reviews and maintaining knowledge of competitive intelligence.
• Supporting publication development and business-related research activities.

Skills, Qualifications, and Requirements

Required qualifications for the CDS role include:

• An advanced scientific degree and familiarity with therapeutic principles and clinical research methodology.
• Experience in data analysis and the ability to clearly communicate with diverse stakeholders.
• Collaborative leadership skills and experience engaging with multidisciplinary teams.
• Strategic and analytical thinking abilities.
• Understanding of the drug development process and relevant business knowledge.
• Willingness to travel domestically for company events.

Roivant Sciences is an equal opportunity employer and discourages unsolicited resumes or agency outreach.

For more information and to apply, visit the original job posting on Himalayas.

This job offer was originally published on Himalayas

Resources

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