Global Clinical Program Lead - Neuroimmunology, Immunology, BioPharmaceuticals R&D

AstraZeneca; Kendall Square (MA); On-site; USD 190,000 - 270,000; Full time

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

Introduction to role:

Are you ready to lead immune-reset programs in neuroimmunology from first-in-patient to pivotal, turning bold science into durable benefit for people with immune-mediated neurological disease? Do you want the accountability and reach to shape strategy while guiding day-to-day execution across complex, global studies?

As Global Clinical Program Lead, you will serve as the clinical authority for two development programs, including multiple sclerosis and neuromuscular disease. You will own benefit/risk and clinical strategy, steer study design and delivery, and represent the programs with internal governance, regulators, investigators and patient partners. Based in Cambridge, MA, you will help accelerate immune-reset approaches designed to recalibrate, not chronically suppress, the immune system-so decisive evidence can reach patients faster.

Accountabilities:

• Clinical Strategy Ownership: Define and drive clinical and scientific strategy across both programs, including benefit/risk, Target Product Profile and Clinical Development Plan; author and oversee clinical components of regulatory documents to align with program goals.
• Study Design and Delivery: Lead endpoint strategy, population definition and selection of innovative trial designs; ensure studies are executed to GCP with clear operational plans that balance speed, quality and patient centricity.
• Program Safety Leadership: Set and oversee program-level safety strategy with Patient Safety; anticipate and manage modality-specific risks of immune-reset therapies (for example, cytokine release syndrome, neurotoxicity, cytopenias, infection); provide clinical oversight of study medical monitoring; represent benefit/risk at Safety Review Committees and IDMC/DMC.
• Regulatory Leadership: Own clinical content for IND/CTA submissions; lead health-authority interactions (FDA, EMA, MHRA and others); craft clear, evidence-based responses to regulatory questions to enable efficient decision-making.
• Governance and Investment Storytelling: Present compelling, data-driven program updates and proposals at internal governance and portfolio committees; align with the Global Clinical Head on strategy and investment decisions.
• External Engagement and Partnerships: Build trusted relationships with key external experts, advisory panels, investigators, sites, CROs and patient-advocacy groups; ensure external insights shape clinical plans and execution.
• Cross-Functional Clinical Leadership: Provide day-to-day matrix leadership to study physicians and clinical scientists; partner closely with Global Project Lead, Regulatory, Patient Safety, Biostatistics, Translational Medicine, Clinical Pharmacology, CMC and Commercial to integrate science, operations and strategy.
• Scientific Surveillance and Innovation: Track advances in immune-mediated neurological disease and immune-reset modalities; translate emerging data and competitive insights into differentiated, hypothesis-driven clinical plans.
• Enterprise Collaboration: Collaborate with enterprise partners, including other therapy areas and external development partners, to share learnings and accelerate delivery; contribute to indications and modalities as the portfolio evolves.
• Team Structure: Lead through influence with no direct reports, setting high standards, clear priorities and a bias for action to deliver results with urgency and quality.

Essential Skills/Experience:

• An MD, or equivalent degree from an accredited university, or an MD (or equivalent) plus a PhD.
• Postgraduate specialty training and board certification in neurology or a related immune-mediated disease specialty, with substantive clinical experience at attending or consultant level.
• At least 5 years'clinical drug-development experience in the biopharmaceutical industry, including leadership of a clinical program or major studies through key milestones (for example, IND/CTA, first-in-patient, end-of-phase or pivotal design).
• Hands-on leadership of the design, delivery and interpretation of multiple industry-sponsored clinical studies.
• Experience leading health-authority interactions and contributing clinical content to regulatory submissions.
• Thorough understanding of the full drug-development process, including interpretation of non-clinical data, clinical research methodology and biostatistics principles.
• Thorough command of FDA, EMA, MHRA and ICH GCP requirements for the conduct of global clinical studies.
• Proven experience leading complex programs and high-performing global cross-functional teams in a matrixed environment.
• Ability to influence senior internal and external stakeholders, frame clear and succinct messages, and simplify complex decisions.
• Attention to detail, a drive for high-quality work, a sense of urgency, and a track record of delivering results.

Desirable Skills/Experience:

Clinical-development experience in neuroimmunology or neuromuscular disease, with knowledge of the external landscape and relationships with key s