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Vice President, Medical Affairs
Innovaderm Research Inc.. Develop and execute the long-term strategic vision for the Medical Affairs division with the CMSO .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive leadership in Medical Monitoring and Pharmacovigilance, with a strong focus on strategic vision, compliance with regulatory frameworks, and client engagement. Proven ability to manage budgets, develop multidisciplinary teams, and ensure quality standards in clinical trial oversight.
Highest-signal resume keywords
Medical Monitoring LeadershipPharmacovigilance ComplianceP&L ManagementClient EngagementRegulatory Framework Expertise
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical MonitoringPharmacovigilanceBudget ManagementRegulatory SubmissionsSignal DetectionCase ProcessingQuality StandardsKPI DevelopmentAudit DefenseTherapeutic Area Expertise
Soft Skills
LeadershipMentoringStrategic ThinkingClient Relationship ManagementTeam Development
Tools & Technologies
PV Safety DatabasesSafety Reporting Automation ToolsAI-Assisted Technologies
Certifications & Qualifications
Medical Doctor (MD, DO)Board Certification in Dermatology or RheumatologyMBA (Asset)
Industry Keywords
Pharmaceutical IndustryBiopharmaceutical IndustryClinical ResearchCROGlobal Clinical Trial RegulationsHealth Authority InteractionsRegulatory InspectionsQuality Management System (QMS)Multilingual CapabilityInternational Regulatory Experience
About the role
Key responsibilities & impact- Develop and execute the long-term strategic vision for the Medical Affairs division with the CMSO
- Own the operating budget and P&L for Medical Monitoring and Pharmacovigilance
- Build capability roadmaps for Medical Monitoring and Pharmacovigilance
- Provide executive oversight of medical monitoring across the clinical trial portfolio
- Lead physician resourcing, including hiring, training, deployment, and performance management
- Maintain medical monitoring SOPs, work instructions, and quality standards
- Escalate complex or high-risk medical monitoring issues
- Provide strategic and operational oversight of Pharmacovigilance, including case processing, signal detection, aggregate reporting, and regulatory submissions
- Ensure compliance with global and country-specific pharmacovigilance legislation
- Lead PV regulatory inspection and internal audit readiness
- Partner with sponsors on pharmacovigilance agreements and safety data exchange agreements
- Partner with Business Development on new business, RFP responses, client presentations, and bid defenses
- Develop strategic client relationships and serve as senior medical contact for key accounts
- Lead competitive pricing models for Medical Affairs services
- Ensure compliance with regulations, the QMS, and sponsor requirements
- Serve as executive signatory and accountability owner for SOPs, quality plans, CAPA plans, and audit/inspection responses
- Lead, mentor, and develop a multidisciplinary Medical Affairs team
- Establish performance frameworks, KPIs, succession planning, and leadership development programs
Requirements
What you’ll need- Medical doctor (MD, DO, or equivalent international medical degree) required
- 12–15 years of progressive experience in the pharmaceutical, biopharmaceutical, or clinical research industry
- 5–7 years in a leadership role within a CRO, pharmaceutical company, or hybrid organization
- Demonstrated experience leading and scaling Medical Monitoring and Pharmacovigilance functions
- Proven track record of client engagement in a commercial, revenue-generating environment
- Deep expertise in global clinical trial regulatory frameworks
- Meaningful exposure to multiple therapeutic areas
- Experience with health authority interactions, regulatory inspections, and audit defense
- Experience managing P&L or budget responsibility
- Board certification in dermatology or rheumatology is an asset but not required
- Advanced business training such as an MBA is an asset but not required
- Working knowledge of PV safety databases and safety reporting automation tools
- Exposure to AI-assisted technologies in medical monitoring, PV, or medical writing workflows
- Published authorship of peer-reviewed scientific manuscripts or presentations at major clinical/scientific conferences
- Multilingual capability or international regulatory experience
- Must be legally able to work in North America
Benefits
Comp & perks- Competitive compensation with performance incentives
- Full benefits
- Stimulating work environment
- Attractive advancement opportunities
- Remote role with frequent travel