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CTI Clinical Trial & Consulting Global Headquarters
100 E. RiverCenter Blvd.
Covington, KY 41011
Main Phone: +1.513.###.####
Main Fax: +1.859.###.####
Where Life-changing Therapies Turn First
CTI is an innovative, international drug and device development organization that delivers a full spectrum of clinical trial and consulting services from bench to commercialization.
A CTI Medical Director is responsible for medical monitoring for clinical trials; for providing scientific and medical expertise for clinical trials, regulatory and scientific affairs programs and real world evidences programs and acting as a medical resource for staff members throughout the company.
What you'll do:
What you'll bring:
- Participate as a leading team member for global clinical trials, providing full medical monitoring services, including, but not limited to collaborating with sponsors, Investigators, statistics, data management, project management and pharmacovigilance.
- Participate as a leading team member with the regulatory and scientific affairs team to develop Innovative protocols, FDA / Regulatory briefing package, consultation on strategic direction for drug development, support development of clinical study reports and NDAs. BLAs and/or other regulatory documents
- Participate as a leading member with the Real World Evidence team to support protocol development, provide clinical expertise, Identify and Interact with key thought leaders and as needed.
- Support Business Development for all CTI departments by providing Medical Expertise and Guidance, attending capabilities meetings, bid defenses, conferences and client meetings as necessary
- Review & manage analysis and reporting of serious adverse events during clinical trials
- Create & conduct employee training/continuing education
- M.D. Degree with U.S. medical license and training
- At least 5 years of experience in Hematology-Oncology
- Experience leading clinical and cross functional teams
- Knowledge of GCP and ICH guidelines
- Experience in clinical trials; FDA experience a plus
- 2+ years pharmaceutical, biotech industry or CRO experience a plus
- 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 teams efforts to improve their local communities (Click here to learn more about our CTI Cares program)
- We are looking toward the future We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
- Our work makes a difference We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
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