Director, Clinical Research Scientist

📋 Description

• • Lead, mentor, and develop a team of Clinical Research Scientists, fostering a high-performing environment that meets the evolving needs of Sumitomo Pharma's oncology portfolio.
• • Drive the strategic and scientific direction of clinical drug development programs, providing expert guidance and insights to cross-functional teams.
• • Oversee the execution of clinical trials from early to late-stage development, ensuring adherence to protocols and regulatory standards.
• • Collaborate closely with Clinical Operations and Medical Directors to support study start-up activities, including presentations at Investigator Meetings (SIVs) and building strong relationships with Principal Investigators.
• • Provide critical support for data review, data cleaning, and intensive monitoring to ensure the integrity and accuracy of clinical trial data.
• • Train and guide Clinical Research Scientists in preparing for and supporting New Drug Application (NDA) submissions and responding to all regulatory inquiries.
• • Actively engage with Senior Management to align clinical development strategies with corporate objectives and contribute to the overall success of the company.
• • Offer scientific and clinical expertise to cross-functional teams, including Medical Directors, Biometrics, Clinical Pharmacology, Regulatory Affairs, Pharmacovigilance/Safety, and Medical Writing, fostering a collaborative and integrated approach to drug development.
• • Support the planning and execution of advisory boards, consultant meetings, and investigator meetings, including the preparation and delivery of impactful presentations.
• • Maintain a comprehensive understanding of the competitive landscape in oncology, identifying strategic development pathways and opportunities for innovation.
• • Stay current with the latest advancements in oncology treatment modalities, drug mechanisms of action, innovative drug development approaches, and evolving regulatory requirements.
• • Proactively identify and recommend process improvements within clinical development to enhance efficiency, quality, and compliance.
• • Conduct thorough medical reviews of clinical trial data to evaluate safety and efficacy, ensuring patient well-being and data integrity.
• • Partner with project teams to meticulously review, analyze, and interpret study results, including exploratory endpoints, ensuring accurate data reporting and robust conclusions.
• • Contribute to the drafting of high-quality manuscripts, publications, and presentations to disseminate research findings and advance scientific knowledge.
• • Demonstrate exceptional people leadership skills, including coaching, mentoring, and developing direct reports to build a cohesive and effective team.
• • Exhibit strong cross-functional leadership in a matrix environment, building alignment and driving outcomes through collaboration with diverse stakeholders without direct authority.
• • Adapt to a fast-paced environment, managing ambiguity, and leading the team through evolving program priorities while maintaining a high standard of delivery excellence.
• • Foster global and cross-cultural effectiveness, working seamlessly across different regions and maintaining diverse and high-performing teams.
• • Apply scientific rigor and sound clinical judgment to guide study design, endpoint selection, safety and efficacy evaluations, and the interpretation of complex clinical data.
• • Possess a high degree of organizational awareness, enabling the ability to connect disparate information and understand the broader strategic context.
• • Ensure all clinical development activities align with Sumitomo Pharma's commitment to addressing patient needs and bringing novel therapies to market.