Global Clinical Operations Program Director

AstraZeneca

Job Location:

Gaithersburg, MD - USA

Hourly Salary: $ 171622 - 257433

Posted on: 4 days ago

Vacancies: 1 Vacancy

Job Summary

At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledge-sharing ambitious thinking and innovation ultimately providingemployees with the opportunity to work across teams functions and even the globe.

Introduction to role

TheGlobal Clinical Operations Program Director (GPD)isacore global role withintheCell Therapy Clinical Operations(CTCO) function.The span of responsibilitiesisbroad and may support one or several products depending onscopeand complexity.The products supported will be in Phase1-3 development but the program may include studies inall phases of drug development.On behalfoftheSenior Global Clinical Operations Program Director (Sr GPD)the GPD providesstrategic operational leadership andoversight of asuiteofglobalclinicalstudieswithin a programcovering all clinicalprogramdeliverablescovering all clinicaloperationsdeliverablesto scope quality budget timeresourceand risk ensuringnew innovative design and delivery models are used appropriately.The role involves integratingstrategydesignfeasibilityand operational planning toproduce business-focusedclinical drug development programsthat alignwith priorities and strategy.The GPD will develop the core clinical operations components for governance interactions with the oversight of the Sr GPD.TheGPDmayalso actas the lead for cross-functional teams in delivery ofclinicalprogramteam (CPT)activities assigned.

TheGPDmay provide project leadershipforcross-functionalclinical submission teams in support of regulatory marketing applications andpost-registration product maintenancedeliverables.

Additionally theGPDmayleador contribute toimprovementandchange projectswithin clinicaloperationsand/orotherbusiness areas.

Accountabilities:

Leadcross-functional teams of authorities in the planning and delivery of a defined clinical program of studiesand/orclinical activitiesto scope quality budget timeplanningtheresource andleadingrisk

Work closely withglobalstudy leaders to provideappropriatestrategicoversight ofaprogram of studies on behalf ofSr GPDandClinical Program Team (CPT)

Provideclinical operationsexpertiseinto the project (e.g. country selection feasibility operational input into designrisksandexternal partner management)using new innovative design and delivery modelsto support governance interactions and project start-up.

Responsible forproviding clinical operationsexpertiseinto the development of new business case opportunities for review by governance bodies (cost timelinesqualityfeasibilityrisk)

On behalf ofCPTresponsible forleadingclinical plans (costFTEsand timelines) in business reporting system such as PLANIT

Lead large or sophisticated results and the process toidentifyand solve/raiseoperational issues and drive delivery to plan through internal or external partners (Alliance partners Clinical Research Organizations (CROs)vendorsand Academic Research Organizations(AROs)).

Act astheAZpointof escalation forstudy teamsforexternal (e.g. CRO) partners for externally led/outsourced studies as appropriate

Responsible for leadership and program management of non-drug project work as assigned e.g.cross functional improvement/changeinitiatives

Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)

Lead cross-functional teams in delivery of assigned clinical program team (CPT) activities

Contribute to functional and cross-functional initiatives as Subject Matter Authorities

Mentor coach and support people development asappropriate.

Activelyparticipatein networking both within and outside thetherapeutic area sharing best practises and lesson learnt

Beanearly adopter for new ways of working and act as ambassadors for changedriving the implementationandutilizationof new initiatives.

Essential skills/experience:

Minimum of university degree (or equivalent) preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.

At least 10years experiencefrom within the pharmaceutical industry or similar large multinational organizations
Must have oncology/hematology experience

Validated knowledge ofproject management tools and processes

Validated experienceinclinical development/drug development process in various phases of development and therapy areas.

Validated ability to learn by working in multiple phases TAsand/or different development situations.

Experience from leading clinical projects and deliverables or similarexpertisefrom otherareas of drug development (such as pharmaceutical development).

Ability to mentor develop and educate staff

Validated leadership promoting motivation and empowerment of othersin order toaccomplishindividual team and organizational objectives

Skilled & experienced in change management

Ability to look for and champion more efficient and effective methods/processes of deliveringclinical operationscomponentsfocusing on key performance metrics around reliability efficiencycostand quality

Excellent written and verbal communication skills negotiationcollaborationand interpersonal skills with ability to work effectively with others at all levels of the organization

Demonstrated ability to set and lead priorities resources performancetargetsand project initiatives in a regional and local environment

Integrity and high ethical standards

Excellent stakeholder leadership skills

Adaptability

Desirable skills/experience:

Project management certification is desirable but not mandatory.

Cell Therapy Study Management Experience in a pharma/biotech setting

Knowledge of process improvementmethodologysuch as Lean Sigma/Change Management is desirable but not mandatory

Regulatory submission experience

Validated knowledge of clinical operations

Experience with development and implementation of digital health initiatives in Clinical Studies

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that mean were 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 $171622 to $257433. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Why AstraZeneca:

Here you will help turn a rich complex pipeline into real treatments by uniting science disciplined execution and smart digital tools. You will collaborate with unexpected teams that challenge ideas and accelerate progress learning alongside peers who value kindness as much as ambition. With investment in cutting-edge capabilities and a clear focus on speed quality and sustainability your leadership will shorten the path from study start-up to submission and ultimately to patients who need our medicines.

Call to Action:

Step forward to lead the clinical programs that shape the next wave of medicinessend your CV today and help us deliver impact at speed!

Date Posted

30-Mar-2026

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.

Required Experience:

Director