Global Clinical Program Lead, Neuroimmunology

AstraZeneca plc

Kendall Square (MA)

On-site

USD 190,000 - 270,000

Full time

4 days ago
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Job summary

AstraZeneca plc in Cambridge, MA seeks a Global Clinical Program Lead to steer immune-reset programs in neuroimmunology from first-in-patient to pivotal trials, owning benefit/risk strategy and clinical development plans.

You will lead regulatory interactions, govern cross-functional teams across global studies, and partner with investigators, regulators, and patient partners to accelerate immune-reset approaches while maintaining safety and scientific rigor.

Qualifications

  • MD or equivalent clinical degree with postgraduate neurology/immune-mediated disease training.
  • 5+ years of clinical drug-development experience in biopharma, with leadership of major studies.
  • Experience leading health-authority interactions and regulatory submissions.
  • Proven ability to lead complex, global cross-functional teams in a matrixed environment.

Responsibilities

  • Define and drive clinical and scientific strategy across two programs, including risk/benefit and development plans.
  • Lead endpoint strategy, study design, and regulatory document content for submissions.
  • Provide program-level safety leadership and medical monitoring oversight.
  • Manage regulatory interactions (FDA/EMA/MHRA) and respond to questions with evidence-based answers.
  • Present data-driven updates to governance and portfolio committees; communicate strategy to executives.
  • Build external partnerships with investigators, sites, CROs and patient groups; incorporate insights into plans.

Skills

MD/DO
Neurology
Clinical drug development
Leadership
Regulatory submissions
FDA interactions
GCP expertise
Cross-functional leadership

Education

MD or MD+PhD

Job description

AstraZeneca plc in Cambridge, MA seeks a Global Clinical Program Lead to steer immune-reset programs in neuroimmunology from first-in-patient to pivotal trials, owning benefit/risk strategy and clinical development plans.

You will lead regulatory interactions, govern cross-functional teams across global studies, and partner with investigators, regulators, and patient partners to accelerate immune-reset approaches while maintaining safety and scientific rigor.

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