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Job description
What You’ll Do:
Lead globalMedical Affairs and RSAteamswith clarity of vision and purpose.
Develop andmaintaindepartmentalglobal business plans.
Meet or exceed department sales and revenueobjectives.
Participate in Business Development (BD) capabilities presentations, prepareforand attend client visits and programs.
Buildhigh performanceteams within each of the functions. Develop, update, andcounselteam members on career development and advancement.
Ensure all projects are completed according to contractual agreements (budget,timelinesand deliverables) and CTI SOPs.
Develop and assess strategies to drive client satisfaction.
Oversee the development of SOPs.
Oversee and review processes fordeliverables,responsible for quality oversight of all project deliverables.
Develop and overseeMedical Monitoring Plans.
Ensure the safety of all patients in clinical trials andensureclinical trials are conducted according to ethical standards in medicine, providing medical, clinicaldevelopmentand regulatory input.
Review and manage all serious adverse events(SAE)during the course ofthe clinical trials, in collaboration withSafetyDepartment.
Collaborate withglobalteamsthroughout theregulatorysubmission and approval process.
Provideleadership for scientific writing projects, collaborating with team members to ensure medical accuracy.
Participate in advisory boards, training programs,anddevelopment and review of scientific writing projects.
Oversee medical review of the protocol, Investigative Drug Brochure (IDB), Case Report Forms (CRFs), Clinical Study Report (CSR), patientnarrativesand other high-profile documents, such as marketing applications, clinical safety/efficacysummariesand overviews.
Develop and managedepartment 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,orMD
Why CTI?
Advance Your Career – We invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
Equal Opportunity Employer/Veterans/Disabled
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Worksite address
covington, KY, 41011, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.