Director of Clinical Affairs

Ontario - Canada - Life Sciences & Health Care - Medical devices - Research & Development - Academic Bachelor

We’re hiring a Director of Clinical Affairs for our client, a large pharmaceutical company. This is a permanent positon.

Feel free to contact

Daniel Lomas, Account manager

Apply now

About this role

Responsibilities

  • Define the vision and clinical strategies that will support meeting our client’s product development and commercialization objectives.
  • Be responsible for the design and successful execution of clinical trials that demonstrate medical product safety and effectiveness and ensuring that trials are conducted in full compliance to GCP.
  • Lead clinical and scientific translation of research and development, as well as business objectives, into clinical requirements for clinical evaluations while meeting regulatory requirements
  • Manage a staff of 5 – 7 individuals
  • Take a leadership role for analysis and interpretation of clinical results for regulatory submission and publications
  • Develop and manage annual budgets for all clinical projects

About you

Requirements

  • BS, BA, or higher degree in the Life Sciences or related disciplines.
  • Minimum 7 years in senior clinical management position in biopharmaceutical or medical device industry or CRO.
  • Additional 5+ years direct experience in clinical trial management.
  • Solid track record in successfully executing Phase I – III Global clinical trials.
  • Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.
  • Strong, hands-on manager with experience in managing clinical affairs staff and CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting.
  • Knowledge of electronic data capture systems and web-based clinical trial management tools.
  • Excellent interpersonal, written / verbal communication & organizational skills.
  • Collaborative team player.
  • Strong program management and financial skills.
  • High level computer skills required (e.g. MS Word, Excel, and PowerPoint).
  • Willing & able to travel domestically and internationally, as required (up to 30%).

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB234699
  • Location: Ontario
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branch: Medical devices
  • Education level: Academic Bachelor
  • Area of Expertise: Research & Development
  • Closing date: Friday, November 22, 2019
Apply now

Feel free to contact

DL

Daniel Lomas

Account manager Brunel Canada Toronto

+1 416 244 2402

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