Associate Director, Clinical Operations Europe, Ref AQ1675

Primary Purpose of the Role

Celgene have recently established their International headquarters in Neuchâtel, Switzerland and are seeking to further develop clinical operations capability.

Having enjoyed tremendous success commercially and from a research perspective their pipeline is extremely healthy. As an organisation, a significant proportion of Celgene’s clinical research is outsourced. We are currently seeking to recruit clinical research professionals with the experience, vision, drive and determination to add value to these research programmes and enhance Celgene’s product development success.

The position calls for a team player with well developed clinical operations and project management experience, strong cultural awareness, confidence in your own position and able to manage internal and external resources.

Critical to success of this role, therefore, will be the ability of the selected candidate to further enhance the reputation of the European business and the value of Europe’s contribution, through both internal and external relationships.

In return, Celgene can offer the right individual a growing environment, with a positive culture where you will be able to take a highly visible role with the opportunity for personal development and growth coupled to the ability to assist in influencing, shaping and developing the clinical research expertise in line with the continued expansion of the Celgene business.

Core Responsibilities

Responsibilities will include, but are not limited to, the following:

  • Overall strategic management for the planning, execution and reporting of multiple clinical programs (phases I – III) needed to support INDs, SNDAs, NDAs with focus on execution, administration and organization.
  • Draft protocols in cooperation with medical staff and statistics group. Set project goals, develop feasibility assessments to plan for accurate number qualified of investigators for study conduct to support clinical development plans.
  • Oversee Clinical Operations Managers and assure adherence to high quality GCP standards for studies. Must participate directly in all study activities as necessary.
  • Participate in drafting/review of integrated clinical study reports, annual reports, Investigator Brochure updates.
  • Develop, track and administer budgets, FTE requirements, and schedules with responsibility for cost, time and quality of clinical operations activities. Must be able to anticipate deviations, and inform management with proposed corrective actions.
  • Prepare RFPs, and participate in the identification, selection and oversight of Contract Research Organizations, central laboratories, IVRS vendors for outsourced programs.
  • Participate on project and clinical teams serving as key liaison to project managers.
  • Interface with all drug development personnel to ensure timelines are met, conflicts resolved and projects are on time and on budget.
  • Provide guidance and expert advice in the areas of SOP development and clinical research regulations

Person Specification and Competencies

  • Advanced degree (or equivalent experience) in a relevant scientific discipline, with significant clinical operations and clinical research management experience.
  • Demonstrated management skills and experience, with success in executing clinical research projects
  • Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
  • Computer literate; familiarity with Microsoft Office programs, in particular, Microsoft Project (or similar planning/tracking software).
  • Clinical project management skills
  • Knowledge of clinical trial design, basic statistics and pharmacokintics a plus
  • Familiarity with all other aspects of the drug development a plus
  • Demonstrate commitment, dedication, co-operation, positive behaviour, adaptability and flexibility with changes in responsibilities and duties

Experience

  • Degree and advanced degree in Life Sciences
  • Significant clinical operations experience, clinical research management experience and expertise within the Oncology therapeutic area

Package

  • An attractive salary and benefits package will be offered, commensurate with experience, for the right candidates.
  • This will include relocation costs, where appropriate.
  • The package is negotiable, based upon the level of experience of the individual.

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