BeiGene is seeking a Development Core Team Leader (DCTL) for the BTK Degrader, Global Hematology. This individual will have clinical and drug development experience and will lead the BTK Degrader within our Hematology organization. The DCTL will serve as the strategic clinical leader, shaping and driving the global development strategy for this asset within specific disease domains.
Reporting directly to the Vice President of Hematology, the DCTL will lead a global, cross-functional team committed to advancing innovative therapies.
This role is crucial for advancing BeiGenes pipeline of innovative therapies and requires a visionary leader with deep expertise in drug development and a passion for improving patient outcomes on a global scale. As the leader of the Development Core Team (DCT), the DCTL will be responsible for the strategic vision, development, and execution of clinical programs. The role will collaborate closely with cross-functional teams, including the GPTL, Regulatory Affairs, Clinical Operations, Commercial, and other key stakeholders, to ensure that development programs meet corporate goals and are aligned with BeiGenes mission to deliver transformative therapies to patients.
BGB16673 is an orally available Brutons tyrosine kinase (BTK) targeting?chimeric degradation activation compound (CDAC)?designed to induce degradation of wildtype and multiple mutant forms of BTK, including those that commonly confer resistance to BTK inhibitors in patients who experience progressive disease.
Key Roles & Responsibilities :Strategic Leadership :Define and oversee the global clinical development strategy for the BTK Degrader, translating corporate objectives into actionable program-level strategies that integrate scientific, clinical, operational, and regulatory considerations.Program Excellence :Continuously refine development plans in response to emerging data and competitive dynamics, ensuring the programs alignment with evolving business priorities. Craft and maintain an integrated development timeline with clearly defined milestones and critical decision points.Collaborative Partnership :Partner with the Global Program Team Leader (GPTL) to craft and execute disease area strategies, optimizing the asset's lifecycle and maximizing its potential impact. Facilitate seamless collaboration across cross-functional teams to support the successful registration and commercialization of the asset.Risk Management :Lead proactive risk management efforts, developing and implementing mitigation strategies to navigate complex clinical and regulatory environments.Clinical Oversight :Provide visionary leadership and medical oversight for ongoing and planned clinical trials, ensuring the Clinical Study Team (CST) delivers high-quality data within established timelines and budgets.Empowered Decision-Making :Operate with strategic autonomy within the DCT, driving program-level decisions while adhering to established governance pathways, including the Development Review Committee and BeiGene Portfolio Review Committee, for key strategic decisions and program milestones.Stakeholder Communication :Foster transparent and consistent communication across all levels of the organization, ensuring that program status, strategic decisions, and key messages are effectively conveyed to senior management and other critical stakeholders.Talent Development :Cultivate and mentor a high-performing team of Medical Directors, guiding them in the design and execution of clinical studies, while fostering their professional growth and development.Regulatory Strategy :Offer strategic guidance during health authority interactions, orchestrating the preparation of regulatory submissions and responses to agency inquiries, ensuring the assets regulatory success.Thought Leadership :Spearhead the generation of impactful publications and represent BeiGene and the Asset team at key external engagements, including investigator meetings, advisory boards, and major medical conferences.Experience or Qualifications :Education :MD, PhD, PharmD, or equivalent advanced degree in a relevant scientific discipline.Experience :A minimum of 10 years of experience in pharmaceutical or biotechnology drug development, with a proven track record of leading successful global development programs.Expertise :In-depth knowledge of clinical development, regulatory requirements, and commercialization processes, particularly in the therapeutic area of focus. demonstrating substantial experience in drug development (including experience with both IND and BLA / NDA submission).Leadership Skills :Demonstrated ability to lead and inspire cross-functional teams, with strong decision-making and problem-solving skills.Communication Skills :Excellent verbal and written communication skills, with the ability to effectively present complex information to a variety of audiences. Effective scientific and team communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.Global Experience :Experience working with global teams and regulatory agencies, with an understanding of the challenges and opportunities of developing therapies in a global market.Talent Development :Strategic leader with demonstrated success tracking record, able to grow and develop the talents and teamsStrategic Thinking :Ability to think critically and strategically to drive the long-term success of development programs.Innovation :A commitment to pushing the boundaries of science and medicine to develop breakthrough therapies.Results-Oriented :A focus on delivering high-quality results within challenging timelines.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
