VP Global Medical Affairs

CTI Clinical Trial and Consulting Services•Raleigh, NC

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Prior leadership experience in a CRO environment.
Experience across multiple therapeutic areas.
Strong network within pharmaceutical and biotech sponsors.
Board Certification.

Responsibilities

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.
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.
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.
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.
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.