Medical Director LATAM (Fixed term)

Key Responsibilities

Medical Monitoring & Scientific Oversight

• Serve as Global and/or Regional Medical Advisor on assigned clinical trials.
• Provide medical and scientific guidance to Project Leaders and clinical teams.
• Support investigative sites with protocol clarifications inclusion/exclusion decisions patient eligibility and safety issues.
• Perform medical review of study documents including Protocols Investigator Drug Brochures (IDBs) CRFs CSRs and patient narratives.
• Conduct medical review and clarification of trialrelated Adverse Events (AEs) and as applicable Serious Adverse Events (SAEs) in collaboration with Pharmacovigilance.
• Support medical input into Analyses of Similar Events (AOSE) and adverse event coding as required.
• Deliver therapeutic area and indication training to clinical project teams.
• Participate in investigator meetings project kickoffs team meetings and client meetings.
• Provide 24/7 medical support for urgent protocolrelated queries in line with local labor laws.

Medical Strategy & Business Development

• Provide expert medical input into the development of medically sound delivery strategies for complex multiregion clinical studies.
• Contribute to proposal development including medical monitoring strategy and budget input.
• Advise internal stakeholders on protocol feasibility regulatory considerations standard of care competitive landscape site and investigator selection and patient recruitment assumptions.
• Participate in bid defense meetings and strategic business development presentations to prospective clients.
• Maintain uptodate knowledge of industry scientific regulatory and therapeutic area developments; contribute to publications as appropriate.

Qualifications

• Medical degree (MD or equivalent)
• Minimum 5 years of clinical practice experience required.
• Specialty training and/or board certification in Oncology
• Typically 57 years of relevant experience in clinical medicine in the pharmaceutical biotech or CRO industry.
• Experience supporting global or regional clinical trials preferred.
• Strong clinical scientific and regulatory knowledge within the relevant therapeutic area.
• Proven ability to provide medical consultation across multiple complex projects.
• Excellent communication presentation and interpersonal skills.
• Strong command of English (written and spoken).
• Ability to work effectively in a matrixed global environment with internal and external stakeholders.
• High level of initiative flexibility and professional judgment.