Global Clinical Operations Program Director

AstraZeneca

Gaithersburg, MDFull-time

Behavioral Health Market Context

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Benefits

The annual base pay for this position ranges from $171,622 to $257,433Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hoursBase pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experienceIn 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 plansIf 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 factors3 more items(s)

Qualifications

  • •Minimum of university degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
  • •Cell Therapy Study Management Experience in a pharma/biotech setting
  • •Regulatory submission experience
  • •Validated knowledge of clinical operations,
  • •Experience with development and implementation of digital health initiatives in Clinical Studies
  • •2 more items(s)

Responsibilities

  • •The Global Clinical Operations Program Director (GPD) is a core global role within the Cell Therapy Clinical Operations (CTCO) function
  • •The span of responsibilities is broad and may support one or several products depending on scope and complexity
  • •The products supported will be in Phase 1-3 development, but the program may include studies in all phases of drug development
  • •On behalf of the Senior Global Clinical Operations Program Director (Sr GPD), the GPD provides strategic operational leadership and oversight of a suite of global clinical studies within a program covering all clinical program deliverables, covering all clinical operations deliverables to scope, quality, budget, time, resource, and risk, ensuring new innovative design and delivery models are used appropriately
  • •The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with priorities and strategy
  • •The GPD will develop the core clinical operations components for governance interactions with the oversight of the Sr GPD
  • •The GPD may also act as the lead for cross-functional teams in delivery of clinical program team (CPT) activities assigned
  • •The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post-registration product maintenance deliverables
  • •Additionally, the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas
  • •Lead cross-functional teams of authorities in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and leading risk
  • •Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT)
  • •Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up
  • •Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk)
  • •On behalf of CPT, responsible for leading clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT
  • •Lead large or sophisticated results and the process to identify and solve/raise operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs))
  • •Act as the AZ point of escalation for study teams for external (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/change initiatives
  • •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 as appropriate
  • •Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learnt
  • •Be an early adopter for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives
  • •20 more items(s)
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