Director, Clinical Development (DCD)

Gaithersburg, Maryland

Posted in Pharmaceuticals
28 days ago

Job Description

The Director of Clinical Development (DCD) sits within Clinical Operations and is accountable for leading the Clinical Program Team (CPT), a strategic and operational leadership team whose remit is to maximize the scientific and clinical relevance and value of Late Respiratory & Immunology (R&I) led projects, and deliver the assessment of clinical Benefit/Risk and clinical development program to time, cost and quality to the Global Product Team (GPT). The DCD is responsible for program leadership of all Late R&I clinical development deliverables (scope, quality, budget, time, resource and risk). The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align withLate R&I priorities and strategy. The DCD brings product knowledge and strategic thinking to support governance interactions, lead the delivery of a program of studies and co-ordinate the delivery of the clinical components of Health Authority submissions and documents.


  • Effectively partner with the Global Clinical Leader (GCL) and Global Project Statistician (GPS) to provide clear direction and aligned goals to the CPT members/delivery teams
  • As leader of the CPT accountable to drive and implement critical initiatives on the program level ensuring the CPT is operating as a high functioning team
  • Responsible/accountable for cross functional leadership e.g. driving cross functional GPT activities
  • Accountable for efficient and effective program management of all GPT clinical development deliverables, including project strategy, design and delivery of CPT driven program/studies to time, on budget and with quality
  • Responsible for clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports and clinical contributions to inspection readiness.
  • Accountable for oversight of all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
  • Drive CPT to contribute appropriate content to support high quality governance interactions
  • Acts as the initial and program-level AZ operational interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
  • Ensure alignment of the clinical strategy, transfer of product knowledge and champion products that are between early and late stage organizations
  • Responsible for leadership and program management of non-drug project work as assigned, eg cross functional improvement initiatives
  • Contribute to functional and cross functional initiatives as Subject Matter Experts
  • Responsible for ensuring timely compliance with companywide governance controls (e.g. financial oversight, planning and control, continuous assurance, Clinical Trial Disclosure)
  • Mentor and support people development within Clinical Operations and other functions successful transitions
  • Be early adopters for new ways of working and act as ambassadors for change

Essential Requirements:
  • Bachelor of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred
  • Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
  • Experience across the product life cycle with experience in late stage development and ideally across multiple therapeutic areas
  • Clinical operations knowledge with strong track record of delivery
  • Comprehensive knowledge of the clinical and pharmaceutical drug development process
  • Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
  • Significant experience of program management and use of project management techniques in complex projects, including resourcing, financial management and business case development
  • Proven ability to develop successful collaborations with external partners
  • Strong strategic influencing skills; ability to influence broadly within and outside the organization
  • Excellent written and verbal communication skills
  • Proven teamwork and ability to work collaboratively across a wide range of disciplines
  • Track record of planning and delivery success
  • Willingness to travel both domestic and international

Desired Requirements:
  • Demonstrated ability to drive process improvement and/or functional work
  • Experience of implementing changes in ways of working that focus on increasing efficiency
  • Regulatory submission experience
  • Previous success of working in Japan and China to ensure delivery of global programs to meet business needs
  • Proven experience in leading teams through change
  • Experience of and insight into the Clinical environment to be able to drive major improvement programs

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