Global Clinical Program Lead, Cell Therapy, Late Development Oncology

AstraZeneca • Gaithersburg, MD

3d • Hybrid

About The Position

This role offers the opportunity to lead late-stage cell therapy programs that can redefine outcomes for patients with prostate cancer. The position involves transforming cutting-edge science into decisive clinical evidence to inform regulators, payers, and clinicians globally. The lead will manage a significant portion of a complex, indication-aligned cluster of studies within a prostate cancer cell therapy program. Responsibilities include partnering with study physicians and clinical scientists to shape study design, oversee conduct and monitoring, and drive data interpretation to determine the benefit-risk profile, intended label, and global value proposition. The role requires translating novel biology into pivotal trials that withstand regulatory scrutiny and deliver real-world impact. Working across diverse expert teams and external partners, the lead will co-lead product and study strategy, set a clear vision, and enable timely decisions, leveraging innovative tools like biomarkers and advanced trial designs to keep the program competitive and bring transformative therapies to patients sooner.

Requirements

• 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 working knowledge of medical affairs and payer environment.
• Proven cross-functional teamwork and collaboration skills.
• Excellent presentation skills; can communicate effectively with internal and external collaborators.
• A clear demonstration of behaviours: Demonstrates AstraZeneca values and Behaviours.
• Agile responsiveness to scientific data; credible in scientific and commercial environments.

Nice To Haves

• PhD (or other complementary degree) in a scientific discipline.
• Good general medical knowledge.
• Experience from different organizations.
• An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development.
• An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements.
• Line management experience.
• Demonstrated ability to lead, coach, and mentor junior physicians/scientists.
• Demonstrated ability leading and motivating teams in a matrix environment.
• Prior experience in prostate cancer and in early development/translational studies.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior