Global Clinical Program Lead, Cell Therapy, Late Development Oncology

Global Clinical Program Lead, Late Development Oncology

Hybrid Working:
Minimum 3 days per week in the office

Location:
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.

• 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.

• 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 to gain acceptance of ideas and influences outcomes to meet organizational objectives.

• Good knowledge of biostatistics, Clinical Development, global regulatory environment and pharmacovigilance and…