Global Neuroimmunology Clinical Program Lead

AstraZeneca plc; Cambridge (MA); Vor Ort; USD 288.000 - 432.000; Vollzeit

Benefits dieser Stelle

Short-term incentive bonuses

Equity-based awards

Health, dental, and vision insurance

Retirement programs

Paid time off

Zusammenfassung

AstraZeneca plc is seeking a Global Clinical Program Lead in Cambridge, MA to own two immune-reset programs from first-in-human to pivotal trials. You will shape strategy, monitor safety, and guide study design while engaging regulators, investigators, and patient partners in a complex global setting.

You will oversee governance updates, collaborate with cross-functional teams across Regulatory, Biostatistics, Translational Medicine, and Commercial, and lead external partnerships to accelerate

Qualifikationen

• MD or equivalent degree from an accredited university, or an MD plus a PhD.
• Postgraduate specialty training and board certification in neurology or related immune-mediated disease.
• At least 5 years' clinical drug-development experience with leadership of a clinical program or major studies through key milestones.
• Hands-on leadership of design, delivery and interpretation of multiple industry-sponsored clinical studies.
• Experience leading health-authority interactions and contributing clinical content to regulatory submissions.

Aufgaben

• Define and drive clinical and scientific strategy across two development programs, including benefit/risk and Clinical Development Plan.
• Lead endpoint strategy, population definition and trial design choices with clear operational plans.
• Provide clinical oversight of safety monitoring and health-authority interactions.
• Own clinical content for IND/CTA submissions and regulator responses.
• Present data-driven program updates at governance and portfolio committees.
• Build external partnerships and align insights with strategy across enterprise teams.

Kenntnisse

Clinical strategy

Study design

Regulatory submissions

GCP compliance

Cross-functional leadership

Regulatory communication

Clinical safety oversight

Governance & updates

Ausbildung

MD or equivalent + PhD

Neurology board certification

Tools

Clinical data management systems

Regulatory submission tools

Jobbeschreibung

AstraZeneca plc is seeking a Global Clinical Program Lead in Cambridge, MA to own two immune-reset programs from first-in-human to pivotal trials. You will shape strategy, monitor safety, and guide study design while engaging regulators, investigators, and patient partners in a complex global setting.

You will oversee governance updates, collaborate with cross-functional teams across Regulatory, Biostatistics, Translational Medicine, and Commercial, and lead external partnerships to accelerate