Global Clinical Program Lead, Late Respiratory and Immunology Clinical Development

AstraZeneca • Gaithersburg, MD

10d • Hybrid

About The Position

We are seeking a driven Global Clinical Program Lead to join our Late Respiratory and Immunology Clinical Development team. This role is accountable to the Global Clinical Head for a significant portion of the clinical program, typically an indication-aligned cluster of studies, especially those with high complexity or involving third-party collaborations. You will lead a team of Global Development Medical Directors and/or Global Development Scientist Directors, working cross-functionally to oversee the design, conduct, monitoring, and data interpretation of multiple studies. The goal is to ensure clinical data supports the determination of the compound's benefits and risks, meeting global market needs for the intended label, indication, and pricing. This role offers the opportunity to be strategic, patient-focused, and entrepreneurial, setting vision and goals aligned with therapeutic area priorities and product strategy. You will manage the balance of cost, time, and quality, develop risk mitigation strategies, represent the program in health authority interactions, review publications, and share findings across your portfolio. The role operates under the highest ethical standards, adhering to SOPs, regulations, and Good Clinical Practice.

Requirements

• M.D., Ph.D., or equivalent medical or scientific qualification.
• At least 5-8 years of relevant clinical development experience, including study design, protocol development, trial implementation, monitoring, data interpretation, and reporting.
• Experience in clinical development and working within cross-functional teams.
• Knowledge of biostatistics, global regulatory requirements, pharmacovigilance, GCP, and clinical trial safety.
• Strong analytical, problem-solving, teamwork, and influencing skills.
• Excellent written and verbal English communication skills.
• Strong presentation and stakeholder engagement capabilities.
• Ability to work effectively across global teams and travel as required.

Responsibilities

• Oversee clinical, scientific, and ethical components of studies, including patient safety at a study and/or program level in compliance with Good Clinical Practice.
• Provide scientific medical input to all relevant study documents (protocol, statistical analysis plan, amendments, informed consent, case report forms, safety, and risk-based monitoring plans) to ensure consistency and alignment with scientific rationale.
• Present scientific medical content at international investigator meetings and support local Marketing Companies for country-level activities.
• Conduct safety surveillance at a study and/or program level, including managing Adverse Event (AE)/Serious AE reporting.
• Review Clinical Study Reports with the Global Clinical Head (GCH) and play a key role in preparing relevant sections (Introduction, Results, Discussion).
• Induct and educate new Global Study Team members.
• Contribute to clinical trial improvement workstreams on behalf of the Clinical function.
• Accountable to GCH and TA leadership for identifying risks and proposing mitigation strategies for successful phase IIb, III, IV or Life Cycle Management studies.
• Deliver clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies, and investigators/sites, solving clinical, scientific, and medical issues within the Global Study Team.
• Serve as the clinical representative for the indication in Global and Clinical Product Teams and/or sub-teams.
• Co-lead the study and program strategy for publication development and approval with the GCH.
• Provide line management for project study physicians and scientists.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree