Chief Medical Officer

CTI Clinical Trial and Consulting Services•Covington, KY

About The Position

The Chief Medical Officer will lead global Medical Affairs and RSA teams with clarity of vision and purpose. This role involves developing and maintaining departmental global business plans, meeting or exceeding department sales and revenue objectives, and participating in Business Development (BD) capabilities presentations. The CMO will prepare for and attend client visits and programs, build high-performance teams, and counsel team members on career development. Ensuring projects meet contractual agreements (budget, timelines, deliverables) and CTI SOPs is crucial. The role also focuses on developing and assessing strategies to drive client satisfaction, overseeing the development of SOPs, and managing quality oversight of all project deliverables. A key responsibility is developing and overseeing Medical Monitoring Plans, ensuring patient safety in clinical trials, and ensuring trials are conducted ethically. This includes providing medical, clinical development, and regulatory input, reviewing and managing serious adverse events (SAE) in collaboration with the Safety Department, and collaborating with global teams throughout the regulatory submission and approval process. The CMO will provide leadership for scientific writing projects, ensuring medical accuracy, and participate in advisory boards, training programs, and the development/review of scientific writing projects. Finally, the role involves overseeing the medical review of critical documents such as protocols, Investigator Drug Brochures (IDB), Case Report Forms (CRFs), Clinical Study Reports (CSR), patient narratives, marketing applications, and clinical safety/efficacy summaries and overviews. The CMO will also develop and manage department budgets.

Requirements

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

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.