Global Clinical Program Lead, Late Respiratory and ImmunologyClinicalDevelopment

AstraZeneca; Gaithersburg (MD); Sur place; USD 288 000 - 432 000; Plein temps

Résumé du poste

AstraZeneca in Gaithersburg, MD is seeking a Global Clinical Program Lead to oversee late-phase respiratory and immunology programs. You will lead cross-functional teams, provide medical input to protocols and safety plans, and drive regulatory interactions toward timely approvals.

The role requires MD/PhD or equivalent, 5–8 years in clinical development, and strong skills in biostatistics, GCP, and global teamwork. Travel as needed and strategic thinking are essential.

Qualifications

• MD, PhD, or equivalent medical/scientific qualification.
• 5–8 years clinical development experience including protocol design and trial implementation.
• Knowledge of biostatistics, global regulatory requirements, and Good Clinical Practice.
• Cross-functional teamwork and stakeholder influencing capabilities.
• Strong analytical and problem-solving skills with excellent communication abilities.
• Ability to manage global teams and travel as needed.

Responsabilités

• Oversee clinical, scientific, and ethical aspects of indication-aligned study clusters at program level.
• Provide medical input to protocols, statistical plans, informed consents, and safety monitoring strategies.
• Lead safety surveillance, adverse event reporting, and clinical study report preparation.
• Represent program at regulatory agency interactions and investigator meetings.
• Line manage Global Development Medical Directors and Scientists while identifying and mitigating program risks.

Connaissances

Cross-functional teamwork

Stakeholder influence

Analytical skills

Communication skills

Global team management

GCP knowledge

Biostatistics knowledge

Travel readiness

Formation

MD, PhD, or equivalent

Description du poste

AstraZeneca seeks a Global Clinical Program Lead to oversee late-phase respiratory and immunology clinical development programs. This role involves managing complex clinical studies, leading cross-functional teams, and ensuring regulatory compliance while advancing pipeline assets toward market approval.

Responsibilities

• Oversee clinical, scientific, and ethical aspects of indication-aligned study clusters at program level
• Provide medical input to protocols, statistical plans, informed consents, and safety monitoring strategies
• Lead safety surveillance, adverse event reporting, and clinical study report preparation
• Represent program at regulatory agency interactions and investigator meetings
• Line manage Global Development Medical Directors and Scientists while identifying and mitigating program risks

Requirements

• M.D., Ph.D., or equivalent medical/scientific qualification
• 5–8 years clinical development experience including protocol design and trial implementation
• Knowledge of biostatistics, global regulatory requirements, and Good Clinical Practice
• Cross-functional teamwork and stakeholder influencing capabilities
• Strong analytical and problem-solving skills with excellent communication abilities
• Ability to manage global teams and travel as needed

Compensation:

$288,059–$432,088 base salary