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

AstraZeneca; Cambridge (MA); In loco; USD 288.000 - 432.000; Tempo pieno

Vantaggi offerti da questo lavoro

Short-term incentive bonuses

Equity-based awards

Commissions for sales roles

Qualified retirement programs

Health, dental and vision coverage

Descrizione del lavoro

AstraZeneca plc seeks a Global Clinical Program Lead to own two immune-reset programs in neuroimmunology, from first-in-patient to pivotal stages. You will define strategy, oversee safety, design trials, and manage regulatory interactions with regulators, investigators and patient partners from Cambridge, MA.

You will guide cross-functional teams across Global Project Lead, Regulatory, Patient Safety and Biostatistics to ensure timely delivery of high-impact studies that recalibrate the immune

Competenze

• MD or equivalent degree; postgraduate specialty training in neurology or related immune-mediated disease.
• Board certification in neurology or related specialty; substantial clinical experience at attending/consultant level.
• 5+ years of clinical drug-development experience in biopharma, 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.
• Thorough understanding of full drug development process and biostatistics principles.
• Experience with FDA/EMA/MHRA/ICH GCP requirements for global clinical studies.
• Proven ability to lead complex programs and matrixed teams; strong influencing skills.

Mansioni

• Define and drive clinical and scientific strategy across two programs, including benefit/risk and Clinical Development Plan.
• Lead endpoint strategy and trial design; ensure studies meet GCP with clear operational plans.
• Oversee program safety strategy and safety oversight at committees and IDMC/DMC.
• Own clinical content for IND/CTA submissions and lead health-authority interactions.
• Present data-driven updates to governance and portfolio committees; align with Global Clinical Head on strategy and investments.
• Build external partnerships with investigators, sites, CROs and patient groups to shape plans.
• Provide matrix leadership to study physicians and clinical scientists across functions.
• Monitor advances in neuroimmunology and translate data into differentiated clinical plans.

Conoscenze

Clinical program leadership

Regulatory interactions

Cross-functional leadership

Global drug development

Stakeholder communication

Formazione

MD or equivalent + PhD

Neurology specialty board certification

Descrizione del lavoro

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 sites, external experts and patient partners.
• Subspecialty training or clinical practice in neuroimmunology or neuromuscular disease.
• Clinical‑development experience with immune‑reset therapies (for example, cell therapies or B‑cell‑directed therapies) in autoimmune indications.
• Familiarity with the CMC‑clinical interface.
• Experience of the clinical/commercial interface.
• Ability to travel nationally and internationally.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life‑changing medicines. In‑person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from 288,059.20 - 432,088.80 USD Annual. Our positions offer eligibility for various incentives—an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Why AstraZeneca

Here you will join a science‑first, collaborative environment where clinicians, data scientists and translational experts work side by side to turn early signals into decisive clinical evidence. We move at pace, pairing digital and data‑driven insight with rigorous medicine to advance programs that aim to change the natural history of complex disease. Unexpected combinations of expertise are encouraged, kindness sits alongside ambition, and your leadership can directly shape how immune‑reset therapies reach patients. If you want to stretch your clinical craft while contributing to a pipeline designed to deliver real‑world impact, this is the place to do it.

Date Posted

30-Oct-2026

Closing Date

12-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.