What You'll Do:
Clinical Development & Medical Oversight
- Provide executive medical oversight across global clinical trials (Phases I-IV).
- Oversee medical monitoring activities including development and review of Medical Monitoring Plans.
- Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs), and other clinical parameters included in medical data review processes.
- Partner with Pharmacovigilance, Regulatory, and Quality Assurance teams to ensure compliance with global regulations.
- Serve as medical expert interacting with investigators, sponsors, and regulatory authorities.
- Support study design, protocol development, and feasibility assessments.
Business Development & Revenue Generation
- Lead and contribute to RFP responses, including strategy, content, and medical positioning.
- Participate in bid defense meetings, client presentations, and capabilities discussions.
- Partner with Commercial/Sales teams to identify growth opportunities and expand client relationships.
- Provide strategic medical input to win new business and increase revenue.
- Represent the organization at industry events, conferences, and client meetings.
Consulting & Scientific Leadership
- Provide medical leadership for consulting engagements and drug development programs.
- Oversee development of clinical documents including protocols, CSRs, regulatory submissions, and publications.
- Serve as subject matter expert for advisory boards and client engagements.
- Ensure scientific integrity across all deliverables.
Operational & Strategic Management
- Develop and execute Medical Affairs strategy aligned with company growth objectives.
- Oversee departmental budgeting, forecasting, and resource allocation.
- Ensure development and maintenance of SOPs and implementation of best practices, creating an environment of continuous improvement.
- Drive process improvements to enhance quality, efficiency, and client satisfaction.
- Oversee administrative policies and processes associated with managing the Medical Affairs function, ensuring team members meet foundational expectations of their role.
People Leadership & Talent Development
- Attract, develop and retain team members.
- Coach and mentor Medical Directors, and Medical Affairs staff, and others as needed.
- Drive performance management, succession planning, and team capability building.
- Provide training and ongoing education for internal teams.
What You'll Bring:
- 10 years of progressive experience in the CRO, pharmaceutical or biotech industry.
- Significant clinical research experience including medical monitoring.
- Deep 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.
- Demonstrated involvement in business development, RFPS, and bid defenses.
- Medical Doctor (MD) degree.
Preferred experience:
- Prior leadership experience in a CRO environment.
- Experience across multiple therapeutic areas.
- Strong network within pharmaceutical and biotech sponsors.
- Board Certification.
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com
Why CTI?
- Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
- Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
- We will never communicate with you directly via Microsoft Teams Messaging or by text message
- We will never ask for your bank account information at any point during the recruitment process
Equal Opportunity Employer/Veterans/Disabled
