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Clinical Operations Director

hace 2 meses

Ciudad de México, Ciudad de México Bristol-Myers Squibb A tiempo completo
Job Summary:

This role will be part of the Regional Clinical Operations (RCO), Latam North, R&D regional organization, and will be responsible for the execution of phase I-IV clinical studies in Colombia and Mexico.

Key Responsibilities:
  1. Lead the planning, conduct, and management of clinical programs (Phase I-IV) in Colombia and Mexico.
  2. Develop and maintain strong working relationships with peers, senior leaders, key stakeholders, and external institutions/networks to influence decisions and achieve optimal results focused on our patients.
  3. Drive alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders.
  4. Identify, maintain, and optimally grow clinical investigative site/institution/network relationships through direct/personal and/or group engagements in most impactful manner.
  5. Support a GDO Quality Culture and ensure a continuous improvement mindset across the group.
Requirements:
  1. Bachelor's degree required preferably within life sciences or equivalent.
  2. Minimum of 10 years of experience in people and project management in a pharma/biotech/CRO organization.
  3. Significant experience in the planning, conduct, and management of clinical programs (Phase I-IV).
  4. Demonstrated ability to drive project-related activities.
  5. Previous experience leading, managing, coaching, and developing direct reports.
  6. In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs.
  7. Understands the drug development process, from early to late stage, including lifecycle management.
  8. Deep knowledge of clinical trial operations, including monitoring methodologies, systems, regulations/compliance, budget, and resource management, and site-facing engagements.
  9. Knowledge of the external country clinical trial environment and stakeholders therein, both for Mexico and Colombia.
  10. Demonstrated organizational and planning skills and independent decision-making ability.
  11. Highly organized and motivated, possessing excellent communication, interpersonal, and presentation skills.
  12. Passionate, accountable, and innovative critical thinker who balances risk/speed for maximum results.
  13. Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide others.
  14. Results-oriented with a proven track record in building strong, collaborative relationships with internal and external stakeholders to manage the Latam North book of work.
  15. Good verbal and written communication skills (both in English and Spanish).