Director, Clinical Science

📋 Description

• • As a Director, Clinical Science at BeiGene, Ltd., you will play a pivotal role in advancing our mission to fight cancer by leading and executing clinical development programs for our innovative assets.
• • You will be instrumental in shaping the strategic direction of clinical programs, ensuring successful execution within defined scope, budget, and timelines, and contributing to the establishment and growth of best-in-class global clinical research capabilities.
• • This role requires a deep understanding of the drug development process from discovery through registration and post-marketing, with a strong emphasis on oncology, though exceptional experience in other therapeutic areas will be considered if transferable skills are evident.
• • You will collaborate closely with a diverse range of internal and external stakeholders, including clinical development teams, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory affairs, molecular diagnostics, and translational research.
• • A key responsibility will be the generation, authoring, updating, and review of critical clinical trial documentation, encompassing protocol concepts, synopses, protocols, amendments, informed consent documents, investigator brochures, clinical study reports, abstracts, posters, manuscripts, and clinical sections of regulatory submissions (INDs, NDAs, annual reports, etc.).
• • You will provide scientific expertise and leadership throughout the lifecycle of clinical studies, from initial planning and site/vendor selection to study conduct, data analysis, and reporting.
• • This includes training BeiGene colleagues, CRO staff, and study site personnel on therapeutic areas, molecules, and clinical protocols, as well as providing scientific and medical support and responding to inquiries from sites, IRBs/IECs, Health Authorities, and CROs.
• • You will be responsible for reviewing, querying, and analyzing clinical trial data, interpreting findings, and presenting them effectively both internally and externally.
• • Representing clinical studies or development programs on cross-functional teams and sub-teams will be a core function, requiring strong communication and influencing skills.
• • Building and maintaining robust networks with opinion leaders and investigators, and organizing/presenting at key opinion leader advisory boards and investigator meetings will be crucial for program success.
• • You will contribute to or conduct essential therapeutic area/indication research and competitor analysis to inform strategic decision-making.
• • Fostering strong relationships with internal subject matter experts and identifying opportunities for continuous process improvement within clinical development will be paramount.
• • This role also involves identifying organizational resource needs, including staff, budget, and systems, and supporting budget planning and management.
• • You will be accountable for ensuring all business practices are compliant with global regulations and guidelines.
• • The Director, Clinical Science will embody BeiGene's values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, demonstrating global competencies such as fostering teamwork, providing honest feedback, self-awareness, inclusivity, initiative, an entrepreneurial mindset, continuous learning, embracing change, results-orientation, analytical thinking, financial excellence, and clear communication.
• • You will be expected to engage in work-related travel approximately 25% of the time, working effectively with colleagues in a global setting.
• • This position offers a unique opportunity to make a significant impact on the development of life-saving cancer therapies and contribute to the growth of a dynamic and rapidly expanding biopharmaceutical company.
• • You will leverage your expertise to drive scientific rigor and operational excellence in clinical development, ultimately benefiting patients worldwide.
• • The role demands a strategic thinker with strong problem-solving and risk-mitigation skills, capable of managing multiple projects in a fast-paced environment.
• • You will utilize industry-standard IT solutions and software programs such as Word, Project, PowerPoint, and Excel to manage and execute your responsibilities effectively.
• • This is a leadership position that requires executive presence and the ability to influence across all levels of the organization and with external collaborators.
• • You will be a key contributor to the scientific narrative and strategic planning for BeiGene's clinical pipeline, ensuring alignment with regulatory requirements and commercial objectives.
• • The position offers the chance to work on cutting-edge research and development in oncology, contributing to novel treatment paradigms.
• • You will be part of a team dedicated to accelerating the delivery of affordable medicines to patients globally.