Chief Medical Officer

Responsibilities

• Lead global Medical Affairs and RSA teams with clarity of vision and purpose.
• Develop and maintain departmental global business plans.
• Meet or exceed department sales and revenue objectives.
• Participate in Business Development (BD) capabilities presentations, prepare for and attend client visits and programs.
• Build high performance teams within each of the functions. Develop, update, and counsel team members on career development and advancement.
• Ensure all projects are completed according to contractual agreements (budget, timelines and deliverables) and CTI SOPs.
• Develop and assess strategies to drive client satisfaction.
• Oversee the development of SOPs.
• Oversee and review processes for deliverables, responsible for quality oversight of all project deliverables.
• Develop and oversee Medical Monitoring Plans.
• Ensure the safety of all patients in clinical trials and ensure clinical trials are conducted according to ethical standards in medicine, providing medical, clinical development and regulatory input.
• Review and manage all serious adverse events (SAE) during the course of the clinical trials, in collaboration with Safety Department.
• Collaborate with global teams throughout the regulatory submission and approval process.
• Provide leadership for scientific writing projects, collaborating with team members to ensure medical accuracy.
• Participate in advisory boards, training programs, and development and review of scientific writing projects.
• Oversee medical review of the protocol, Investigative Drug Brochure (IDB), Case Report Forms (CRFs), Clinical Study Report (CSR), patient narratives and other high-profile documents, such as marketing applications, clinical safety/efficacy summaries and overviews.
• Develop and manage department budgets.

Qualifications

• 15 years of pharmaceutical / Contract Research Organization (CRO), drug development, regulatory experience, with progressive management responsibilities.
• Scientific, regulatory, clinical trial or drug development experience.
• Thorough knowledge of relevant FDA and other international health authorities’ regulations and guidelines, including directly interacting with such authorities, and GCP and ICH guidelines.
• Master’s, PhD, or MD.