Global Clinical Program Lead, Cell Therapy, Late Development Oncology

Job Title

Essential Skills/Experience

Desirable Skills/Experience

Accountabilities

Location

Accountabilities

Essential Skills/Experience

Desirable Skills/Experience

Working Conditions

Benefits

Application Instructions

Location Gaithersburg, Maryland. Hybrid Working: Minimum 3 days per week in the office

Job Title

Global Clinical Program Lead, Cell Therapy, Late Development Oncology

About the Role

Steer late-stage cell therapy programs that redefine outcomes for patients with prostate cancer. Transform cutting-edge science into decisive clinical evidence that informs regulators, payers, and clinicians worldwide.

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
• 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

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

Qualifications

• 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

Skills

• 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 Behaviors
• Able to explore positions and alternatives to reach agreements and solutions; presents clear arguments to gain acceptance of ideas and influences outcomes to meet organizational objectives

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

Application Instructions

Please visit our careers website to apply: AstraZeneca Careers. For more information about AstraZeneca, please follow us on LinkedIn, Facebook, and Instagram.