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AstraZeneca · 1 day ago

Global Study Director

South San Francisco, CA

Full-time

Hybrid

Senior Level

$163K/yr - $244K/yr

7+ years exp

AstraZeneca is committed to innovation and collaboration in the healthcare sector, and they are seeking a Global Study Director to lead clinical studies in Cell Therapy. The role involves driving operational planning, managing clinical trials, and ensuring compliance with regulatory requirements while mentoring team members.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Lead and coordinate a cross-functional study team to ensure clinical study progress according to timelines, budget, and quality standards

Contribute to vendor/ESP selection activities and lead operational oversight at the study level

Assist with operational planning for upcoming clinical studies, interfacing with cross-functional partners

Collaborate to establish strategies for increasing efficiency of global study teams

Facilitate communication across functions and provide guidance to study team members

Serve as the primary AZ contact for outsourced studies, ensuring delivery according to agreed standards

Hold accountability for essential study level documents development

Ensure external service providers perform to contracted goals and timelines

Develop and maintain relevant study plans, including risk management planning

Oversee study level performance against plans, milestones, and KPIs

Identify and report quality issues within the study and collaborate to overcome barriers

Ensure Trial Master File completion and compliance with governance controls

Manage study budget through lifecycle and provide progress reports

Ensure studies are inspection-ready at all times

Support professional development of team members

Provide guidance and mentoring to less experienced colleagues

Lead non-drug project work and improvement projects

Qualification

Clinical trial experienceGlobal study leadershipICH-GCP guidelines knowledgeProject management experienceHematology expertiseOncology expertiseComplex problem solvingCommunication skillsExternal provider managementProject management certificationCell therapy experienceGlobal phase 3 study experienceMentoring abilitiesInterpersonal skillsStrategic thinking

Required

University degree or equivalent in medical or biological sciences or discipline associated with clinical research

Proven project management experience and training

At least 7 years of clinical trial experience

At least 3 years of experience in global study leadership and team leadership

Demonstrated clinical trial expertise in hematology and/or oncology

Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements

Thorough understanding of the cross-functional clinical trial process

Strong strategic and critical thinking abilities

Proven skills in complex problem solving and decision-making

Strong abilities in establishing effective working relationships with senior stakeholders

Demonstrated abilities in mentoring

Excellent communication and interpersonal skills

Ability to manage multiple competing priorities

Experience in external provider oversight and management

Preferred

Advanced degree, masters level education or higher

Project management certification

5 years of experience in global study leadership and team leadership

Significant hematology/oncology expertise

Expertise in different phases of clinical delivery

Experience with project management software solutions

Cell therapy/CAR-T experience

Global phase 3 study experience

Benefits

Short-term incentive bonuses

Equity-based awards for salaried roles

Commissions for sales roles

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage in accordance with the terms of the applicable plans

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees