VP Global Medical Affairs

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 intera...