Global Clinical Program Lead, Cell Therapy, Late Development Oncology

Job Title: Global Clinical Program Lead, Late Development OncologyHybrid Working: Minimum 3 days per week in the officeLocation: Gaithersburg, Maryland.Are you ready to steer late-stage cell therapy programs that can redefine outcomes for patients with prostate cancer? This is a chance to transform cutting-edge science into decisive clinical evidence that informs regulators, payers and clinicians around the world.You will lead a significant portion of a complex, indication-aligned cluster of studies within a prostate cancer cell therapy program.

Partnering with study physicians and clinical scientists, you will shape study design, oversee conduct and monitoring, and drive data interpretation to determine the benefit-risk profile, intended label and global value proposition. Can you translate novel biology into pivotal trials that withstand regulatory scrutiny and deliver real-world impact?Working across diverse expert teams and external partners, you will co-lead product and study strategy, set a clear vision, and enable timely decisions.

You will leverage innovative tools-from biomarkers to advanced trial designs-to keep our program competitive and to bring transformative therapies to patients sooner.Accountabilities:- Clinical Program Leadership: Set vision and goals for the assigned portion of the program aligned to enterprise and product strategy; own Clinical Program Team deliverables; prioritize clinical activities and enable forward-looking risk mitigation to accelerate milestones and maintain competitive advantage.- Study Design and Decision-Making: Serve as the single-point accountable leader for the design, delivery and interpretation of assigned clinical studies; ensure ethical and scientific integrity; contribute to target product profile, clinical plans and labelling decisions, often as a delegate of the Global Clinical Head.- Trial Delivery and Oversight: Drive hands-on delivery for Phase II-IV studies; collaborate seamlessly with global R&D colleagues; identify risks early and implement mitigation to keep trials on time, on budget and inspection-ready; when required and medically qualified, act as Study Physician.- External Engagement and Regulatory Interface: Represent the company with regulators, ethics committees, investigators and alliance partners; provide clear, credible clinical responses; build trusted relationships with AROs/CROs and international collaborators; apply strategic intent in interactions with authorities, payers and key external experts.- Scientific Analysis and Evidence Generation: Maintain up-to-date knowledge of relevant literature; deliver balanced, statistically robust analyses to inform program decisions; proactively generate scientific questions and lifecycle opportunities that create value for the asset.- Cross-Functional Ways of Working: Rapidly implement new processes and systems; promote proactive, solution-oriented behaviors across sub-teams; enable quick and effective troubleshooting; coach team members to build future talent and high-performing matrix teams; act as PSO lead or delegate for sign-off responsibilities.- Ethics and Compliance: Uphold the highest ethical standards; ensure compliance with internal SOPs, Good Clinical Practice, and global/local regulations; when not medically qualified, exercise sound judgment to refer specific medical queries to the designated physician.Essential Skills/Experience:- Graduate of a recognized school of medicine with an M.D.

degree or equivalent or a life science-based degree.- Prior experience in cell therapy.- Significant (>5 years) clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results.- Proven track record of successful clinical delivery with demonstrated examples of strategic influence to clinical studies/programs.- Explores positions and alternatives to reach agreements and solutions; presents clear arguments