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Director Clinical Operations Oncology

Reference Number: 2829
Location: Mid-Atlantic

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Director Clinical Operations Oncology.

As part of Global Medicines Development (GMD), Clinical Operations is the organizational home for the program and project management of late phase clinical projects.  The Director Clinical Operations Oncology is a senior leader within the Clinical Operations Therapy Area (TA) and manages both drug projects and strategic improvement projects as part of the overall portfolio delivery.  The TA alignment allows the development of deep TA knowledge and expertise as well as close integration with cross-functional GMD experts.

The Director Clinical Operations Oncology is a key leadership role within the Clinical Project Team (CPT) responsible for driving the clinical development program and for integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with Global Medicines Development (GMD) priorities and strategy.  This position brings product knowledge to define the value of drug programs including the delivery of studies, clinical components of submissions, publications, and maintenance support for regulatory interactions.  The incumbent will secure cross functional resources to accomplish delivery of the clinical program and incorporates and aligns input from the other clinical experts that are required for the delivery of the integrated plans.

Major tasks and responsibilities will include:

  • Responsible for efficient and effective program management of all GMD clinical development deliverables (scope, quality, budget, time, resource, and risk), including delivery of programs of studies, clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports, clinical contributions to inspection readiness, and internal governance interactions.
  • As the most senior clinical operations leader, 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. country selection, feasibility, operational input into design, external partner management).
  • In collaboration with the Medical Science Director, provides strategic and operational leadership within the program and cross-functional GMD environment.
  • Responsible for initial company operational interface with external partners (e.g. Contract Research Organizations and Academic Research Organizations) for program planning of externally managed/outsourced studies.
  • Identifies and resolves issues within the clinical program including the escalation of the issue to the appropriate individual/functional group for resolution.  This will also include supporting delivery teams.
  • Responsible for ensuring timely compliance with company-wide governance controls (e.g. Sarbanes-Oxley, Continuous assurance, Clinical Trial Disclosure).
  • Responsible for cross-functional leadership roles as delegated from Medical Science Director and/or cross-functional Global Product Team, e.g. leadership of cross-functional Global Product Team activities.
  • Responsible for leadership and program management of non-drug project work such as strategic improvement projects, as assigned.
  • Coaches, supports and sets direction for other members of the clinical development team.

We seek candidates with the following qualifications:

  • Bachelor of Science/Master 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 extensive experience in late stage development and ideally across multiple therapeutic areas.
  • Comprehensive knowledge of the clinical and pharmaceutical drug development process.
  • Experience within oncology therapy area preferred.
  • 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 and financial management.
  • Proven ability to develop successful collaborations external partners as well as with colleagues in Japan and China to ensure delivery of global programs to meet business needs.
  • 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.
  • Proven experience in leading teams through change.
  • Experience of and insight into the Clinical environment to be able to drive major improvement programs.
  • Willingness to travel both domestically and internationally.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2829. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.