Chief Medical Officer

Consulting, Inc.; Covington (KY); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Career progression opportunities

Tuition reimbursement

Flexible schedules

Cash bonuses annually

Job summary

Consulting, Inc. is seeking an experienced leader in Covington, KY, to oversee Medical Affairs and RSA teams. The ideal candidate will bring 15 years of experience in the pharmaceutical industry or CRO, with a background in drug development and regulatory compliance.

This role emphasizes strong leadership, scientific writing, and management skills, while ensuring the highest standards in clinical trials and departmental governance. The company offers robust career progression opportunities, training support, and a commitment to work-life balance.

Qualifications

• 15 years of experience in pharmaceutical or CRO with management roles.
• Expertise in FDA regulations, GCP, and ICH guidelines.

Responsibilities

• Lead Medical Affairs and RSA teams effectively.
• Manage departmental global business plans and budgets.
• Ensure compliance with contractual agreements and SOPs.
• Oversee quality of project deliverables and safety in clinical trials.

Skills

Pharmaceutical expertise

Regulatory knowledge

Leadership

Scientific writing

Education

Master’s, PhD, or MD

Job description

Location

Rivercenter, Covington, KY 100 E Rivercenter Blvd Suite 1600 Covington, KY 41011, USA

Responsibilities

• Lead globalMedical 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.

What You’ll Bring

• 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.

Benefits

• We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward.
• We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department.
• We value our people – We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade.
• Our culture is unparalleled – Click here to learn more about “The CTI Way.”
• We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program).

Equal Opportunity Statement

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.