Senior Clinical Operations Director for Real World Evidence

il y a 1 semaine

Bagneux, Hauts-de-France VitalAire Canada Inc. Temps plein
RWE & Clinical Operations Leadership Opportunity

We are seeking a seasoned Clinical Operations Director to lead our Real World Evidence (RWE) initiatives and oversee the execution of clinical trials. This is an exciting opportunity to shape the future of evidence generation in the healthcare industry.

About the Role

The successful candidate will be responsible for planning, designing, and executing RWE studies and clinical trials, ensuring adherence to regulatory guidelines while optimizing operational effectiveness. They will work closely with cross-functional teams, including HEOR, Biometry, Medical Affairs, and Market Access, to streamline interactions and responsibilities regarding global evidence generation.

Key Responsibilities

  1. RWE Studies & Clinical Trials Planning, Design, and Execution:
  • Develop strategic and pragmatic solutions to address business needs, aligned with evidence gaps and stakeholder requirements.
  • Manage and oversee RWE studies and clinical trials across therapies.
  • Establish and maintain clinical studies governance processes.
  • Monitor global activities in clinical research and provide guidance to countries on study protocols and execution.
Operational Excellence:Drive operational efficiency and streamline processes to ensure operational effectiveness.Optimize collaboration with external partners (CROs) and identify preferred partners.Manage studies budget and targets.Train and support end-users.Quality, Regulatory, and Compliance:
  • Evaluate and approve study protocols to safeguard quality.
  • Ensure scientific rigor and regulatory compliance for all research activities.
  • Provide guidance on best regulatory approaches.
  • Support quality management activities.
VBHC Transformation and Smart Evidence Generation:
  • Maintain and develop relationships with key institutions, research groups, CROs, KOLs, and other RWE thought-leaders.
  • Engage with regulatory bodies and health agencies to unlock challenges and anticipate future trends.
  • Support outcomes collection and research activities for efficient and ongoing RWE generation.
  • Contribute to the development of a smart evidence generation roadmap.

Requirements and Qualifications

  • A minimum of 8-10 years of experience in healthcare or life sciences in a managing position.
  • Strong knowledge of the pharmaceutical industry and its regulations.
  • Ability to interpret and apply regulators' thinking to projects.
  • Excellent understanding of RWE and secondary use of data challenges and opportunities.
  • Demonstrated skills in designing and executing RWE studies and clinical trials.
  • Demonstrated ability to lead team members in conveying evidence of value.
  • Ability to adapt in a rapidly changing environment.
  • Outstanding leadership and interpersonal skills.
  • Excellent English language skills.

Estimated Salary Range: $120,000 - $180,000 per annum, depending on experience

About Us

We are a world leader in gases, technologies, and services for Industry and Health. We leverage energy and environmental transition, changes in healthcare, and digitization. Join us for a stimulating experience with learning and development opportunities in an open, collaborative, and respectful environment.

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