VP Global Medical Affairs

5w1 month ago

CTI

Raleigh, US · Full-time · $280,000 – $350,000

About this role

This executive leadership role provides strategic medical oversight across all global clinical trials, from Phase I through Phase IV. As VP of Global Medical Affairs, you will ensure the scientific integrity and regulatory compliance of drug development programs while driving business growth and client partnerships.

Day-to-day responsibilities include overseeing medical monitoring activities and safety data review, including Serious Adverse Events, and collaborating closely with Pharmacovigilance, Regulatory, and Quality Assurance teams. You will also serve as the medical expert in interactions with investigators, sponsors, and regulatory authorities, and lead RFP responses, bid defense meetings, and client presentations to win new business.

You will lead a team of Medical Directors and Medical Affairs staff, focusing on talent development, performance management, and succession planning. The role requires building a culture of continuous improvement by developing SOPs, implementing best practices, and driving process enhancements that improve quality, efficiency, and client satisfaction.

This position offers the opportunity to shape medical affairs strategy in alignment with company growth objectives, represent the organization at industry events and conferences, and contribute to the development of critical clinical documents including protocols, CSRs, and regulatory submissions.

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 global regulatory requirements and clinical trial processes.
Proven ability to serve as a medical expert in interactions with investigators, sponsors, and regulatory authorities.
Experience leading RFP responses and participating in business development activities.

Responsibilities

Provide executive medical oversight across global clinical trials (Phases I-IV).
Oversee medical monitoring activities and safety data review, including Serious Adverse Events (SAEs).
Partner with Pharmacovigilance, Regulatory, and Quality Assurance teams to ensure global regulatory compliance.
Lead and contribute to RFP responses, bid defense meetings, and client presentations to drive revenue growth.
Provide medical leadership for consulting engagements and drug development programs.
Develop and execute Medical Affairs strategy aligned with company growth objectives.
Attract, develop, and retain team members while coaching Medical Directors and Medical Affairs staff.
Drive process improvements and oversee departmental budgeting, forecasting, and resource allocation.

Benefits

Opportunity to shape and execute global Medical Affairs strategy.
Leadership role with ownership of a high-impact team in a growing CRO.
Direct involvement in business development and revenue generation.
Represent the organization at industry events and conferences.
Collaboration with cross-functional teams including Pharmacovigilance and Regulatory.