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Global Study Director

Global Study Director

AstraZenecaSouth San Francisco, CA, US
30+ days ago
Job type
  • Full-time
Job description

Global Study Director, Cell Therapy, Clinical Operations

Do you have expertise in Oncology, and experience with cell therapy? As a Global Study Director, Cell Therapy, Clinical Operations, you will deliver a single or several smaller Cell Therapy development programs.

Join us to apply your expertise to impact the lives of patients living with cancer, follow the science, and turn ideas into life-changing medicines. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. A place built on courage, curiosity, and collaboration we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

Pioneers of collaborative research, we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centers. Working seamlessly and inclusively together, we expedite research in some of the hardest-to-treat cancers. Do you want an opportunity to build a rewarding and meaningful career as part of a team committed to improving the lives of millions with cancer?

You Will :

  • Clinical Operations delivery of a single or several smaller development programs or leading multiple studies or single sophisticated / novel studies.
  • May also provide authoritative input to other non-drug programs and improvement projects.
  • Provides authoritative clinical operational input into project or study level documents, for example, clinical development plan, clinical study protocol, clinical study report, and may own the delivery of study documents.
  • May lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions.
  • Owns the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality, and scientific standards.
  • Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study / program leaders or leadership of the study team as appropriate.
  • Ensure sponsor oversight throughout the life of the study.
  • Develops and leads effective risk management / mitigation plans to ensure timely delivery to quality, budget, and time and advance issues to partners as appropriate.
  • Responsible for planning and leading issue customer concern and resolution.
  • Provide input to forecasting and management of study / program delivery costs, resource, and timelines.
  • Accountable for the quality of study / program planning information into relevant planning systems.
  • Mentors and supports the development of individuals within the organization.
  • Contributes to operational interactions with external entities, including regulatory agencies, preferred partners / suppliers, and external collaborators.
  • Responsible for oversight of CROs and other clinically outsourced third-party vendors for outsourced studies and programs.
  • Responsible for study-level reporting of progress, risks, and issues.
  • Lead the study delivery-related activities associated with regulatory inspections / audits in liaison with Clinical Quality Assurance.
  • Provide procurement clear specifications for study or program-specific outsourcing.
  • Review and operational approval of study or program-specific contracts or work orders.

You Have :

  • Bachelor's degree in related subject area, preferably in medical or biological science.
  • 10+ years of drug development experience from within the pharmaceutical or biotech industries.
  • Required Skills :

  • Clinical Operations and Cell Therapy or Gene Therapy experience.
  • Extensive and shown experience in driving operational delivery to timelines, cost, and quality.
  • Shown experience leading delivery through internal and external organizations.
  • Excellent knowledge of ICH-GCP principles.
  • Experience and strength in working and leading in matrix teams.
  • Strong collaborative communications skills including the ability to engage with a diverse client base and lead through conflict.
  • Proven track record in problem solving and issues management that is solution focused.
  • Ability to lead strategic and / or operational management of individual clinical trials.
  • Experience in providing clear requirements for external contracts.
  • Experience in selection of external providers and development / review of contracts.
  • Confirmed oversight of external providers.
  • Desirable Skills :

  • Advanced degree e.g. PhD, MSc, MPhil.
  • Program management qualification (e.g. MBA, PRINCE2, PMP) within the context of Clinical Drug Development.
  • Experience in a variety of academic / CRO / Sponsor organizations and countries.
  • Experience of early-phase clinical delivery.
  • Our Benefits :

    Benefits offered include :

  • A qualified retirement program [401(k) plan]
  • Paid vacation, holidays, and paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage following 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.
  • The annual base salary for this position ranges from $162,566 to $243,849. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In 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).

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    Study Director • South San Francisco, CA, US

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