Director, Head of Clinical Operations, Latam North
hace 7 días
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:
• Lead the Latam North Cluster clinical operations teams and ensure execution excellence in operational planning, implementation, trial management, site management, and monitoring of clinical trials (registrational, non-registrational/Investigator Sponsored Research (ISR)) conducted within Colombia and Mexico.
• Serve as a member of the RCO LATAM Senior Leadership Team and be part of the RCO and GDO extended leadership teams.
• Collaborate with development teams, local medical, and key BMS stakeholders to ensure effective management of Latam North conducted clinical trials.
• Support a GDO Quality culture by collaborating with both the GDO Global Clinical Compliance team and the GQ Clinical Trial and Safety group.
Requirements:
• Bachelor's degree required, preferably within life sciences or equivalent.
• Minimum of 10 years of experience in people and project management in a pharma/biotech/CRO organization.
• Significant experience in the planning, conduct, and management of clinical programs (Phase I-IV).
• Demonstrated ability to drive project-related activities.
• Previous experience leading, managing, coaching, and developing direct reports.
• In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs.
• Understand the drug development process, from early to late stage, including lifecycle management.
• Deep knowledge of clinical trial operations, including monitoring methodologies, systems, regulations/compliance, budget, and resource management, and site-facing engagements.
• Knowledge of the external country clinical trial environment and stakeholders therein, both for Mexico and Colombia.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Highly organized and motivated, possessing excellent communication, interpersonal, and presentation skills.
• Passionate, accountable, and innovative critical thinker who balances risk/speed for maximum results.
• Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide others.
• 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.
• Good verbal and written communication skills (both in English and Spanish).
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