Senior Global Clinical Operations Program Director

4w1 month ago

AstraZeneca

Boston, US · Full-time · $220,000 – $300,000

About this role

Are you ready to lead global cell therapy programs that accelerate breakthrough medicines to patients? As a Senior Global Clinical Operations Program Director, you will guide the operational delivery of an ambitious clinical development plan, translating strategy into measurable outcomes that matter for patients and the business.

In this role, you will integrate strategy, build, feasibility, and operational planning to deliver programs within defined parameters of scope, quality, budget, and schedule. You will build clinical program structures, champion creative approaches to composition and implementation, and ensure robust governance across complex, global studies.

You will be a core leader on the Clinical Program Team, partnering across disciplines to enhance the scientific and clinical relevance of our cell therapy assets. You will partner with the Global Clinical Head and the Biometrics Team Leader to set clear direction and shared goals for Clinical Program Team members and clinical delivery teams.

This is your opportunity to influence direction at scale while developing high-performing teams and trusted partnerships that drive value. You will provide line management to global clinical operational leaders, serve as AstraZeneca's decision maker with outsourced partners, and lead clinical contributions to inspection readiness for marketing applications.

Requirements

Bachelor of Science or Master of Science degree with a minimum of 10 years experience in related field.
Proven ability to lead end-to-end oversight of clinical program activities in a global pharmaceutical or biotechnology setting.
Experience providing line management to global clinical operational leaders at the study and program levels.
Demonstrated expertise in clinical operations for cell therapy or advanced therapy medicinal products.
Strong track record of partnering with cross-functional teams including Global Clinical Heads and Biometrics Team Leaders.
Experience managing clinical plans—cost, FTEs, and timelines—in business reporting systems such as PLANIT.
Ability to serve as the initial and program-level operational interface with outsourced partners (CROs/AROs) and collaboration/alliance partners.
Knowledge of regulatory submission processes and inspection readiness for marketing applications.

Responsibilities

Lead end-to-end oversight of clinical program activities, advancing relevant issues to senior governance and providing clinical operations expertise in feasibility, country selection, operational input to design, risk management, and external partner management.
Use innovative design and delivery models to accelerate project start-up and informed decision-making.
Partner with the Global Clinical Head and the Biometrics Team Leader to set clear direction and shared goals for Clinical Program Team members and clinical delivery teams.
Manage all clinical development deliverables to scope, quality, budget, and time as a core member of the Clinical Program Team.
Drive program strategy, study design, resourcing, and risk mitigation that translate into predictable delivery and business impact.
Establish team structures, governance, and ways of working that enable a high-performing Clinical Program Team focused on outcomes and continuous improvement.
Provide line management to global clinical operational leaders at the study and program levels, including Global Study Associate Directors or Global Study Directors and Global Program Directors.
Own the clinical operations components of regulatory submissions, support regulatory interactions and reporting, and lead clinical contributions to inspection readiness for marketing applications and post-registration maintenance.

Benefits

Opportunity to lead global cell therapy programs that accelerate breakthrough medicines to patients.
Influence direction at scale while developing high-performing teams and trusted partnerships.
Champion creative approaches to clinical program composition and implementation.
Contribute to non-drug project work and cross-functional improvement initiatives.
Serve as a Subject Matter Expert and mentor/coach colleagues within a global pharmaceutical leader.