Director Global Study Leader - Cellular Therapy, Oncology R&D

Gaithersburg, MD, USA
Job Description

The Director Global Study Leader is responsible for delivering a single or several smaller development programs or leading multiple studies or single complex/novel studies such as platform, basket, etc.

The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy is required.

The Director Global Study Leader may also provide expert input to other non-drug programs and improvement projects.

  • Provides expert clinical operational input into project or study level documents, for example, clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents
  • With oversight from the Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
  • Leads 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 manages 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 escalation 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 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 or program level reporting of progress, risks and issues
  • Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Provision to procurement clear specifications for study or program specific outsourcing
  • Review and operational approval of study or program specific contracts or work orders
Desired Skills & Experience

Essential for the role

  • Bachelor’s degree in the related subject area, preferably in medical or biological science.
  • Extensive drug development experience
  • Extensive experience in leading studies/programs in clinical development
  • Proven experience in Cell Therapy
  • Comprehensive knowledge of the clinical and pharmaceutical drug development process
  • Extensive and proven experience in driving operational delivery to timelines, cost, and quality
  • Proven experience leading delivery through internal and external organizations.
  • Excellent knowledge of ICH-GCP principles
  • Project Management experience within the context of Clinical Drug Development
  • 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 manage through conflict
  • Proven ability 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
  • Proven oversight of external providers


Desirable for the role

  • Graduate degree e.g. Ph.D., MSc
  • Program management qualification (e.g. MBA, PMP)
  • Experience in a variety of academic/CRO/Sponsor organizations and countries
  • Experience of early phase clinical development
Gaithersburg, Maryland, USA