Senior Director, Medical Affairs Operations

DBV Technologies

. Build and own the U.S. Medical Affairs strategic and tactical plan with projects, owners, milestones, budgets and KPIs . Run the Medical Affairs planning cadence and maintain an integrated view of all workstreams .

Posted 10/15/2026full-timeWarren • New Jersey • United StatesSenior💰 $250,000 - $300,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Medical Affairs operations, including strategic planning, budget management, and compliance with industry regulations. Proven ability to lead cross-functional teams and operationalize product launches while ensuring adherence to standards and metrics.

Highest-signal resume keywords

Medical Affairs OperationsBudget ManagementPhRMA Code ComplianceDashboard Design and ReportingProject Management Certification

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Medical Affairs Strategic PlanningBudget-to-Forecast Variance ReportingKPI DevelopmentGrants ManagementContracting and Vendor SelectionData Integrity ManagementFinancial AnalysisProject ManagementOperational ExcellenceRisk Management

Soft Skills

Influencing Without AuthorityTeam LeadershipCross-Functional CollaborationProblem SolvingJudgment Under Ambiguity

Tools & Technologies

CRM SystemsProject Tracking ToolsExcelContract Management SystemsDashboard Tools

Certifications & Qualifications

Project Management Professional (PMP)Operational Excellence Training

Industry Keywords

Biopharmaceutical IndustryU.S. Product LaunchAnti-Kickback StatuteSunshine ActGCP RequirementsFair-Market-Value PrinciplesACCME StandardsInvestigator-Initiated StudiesAllergy/ImmunologyPediatrics

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Build and own the U.S. Medical Affairs strategic and tactical plan with projects, owners, milestones, budgets and KPIs
Run the Medical Affairs planning cadence and maintain an integrated view of all workstreams
Design and maintain dashboards and project-tracking mechanisms; surface risks, slippage and resource conflicts
Serve as Medical Affairs operational lead for cross-functional Launch Readiness Reviews
Partner with Commercial, Market Access, Regulatory, Pharmacovigilance and Compliance to integrate deliverables into the launch plan
Operationalize the U.S. advisory board plan, including participant selection, fair-market-value contracting, logistics, documentation and insights capture
Oversee congress planning and medical meeting operations
Establish compliant end-to-end processes for medical education grants and investigator-initiated studies
Chair or coordinate the Grants/IIS review committee and maintain audit trails and reporting
Oversee Medical Affairs contracting, vendor selection, onboarding, performance management and renewals
Own the U.S. Medical Affairs budget, accruals, reforecasts and long-range planning input
Deliver budget-to-forecast variance reporting and spend transparency
Capture and report transfers of value under the Physician Payments Sunshine Act / Open Payments and applicable state laws
Ensure compliance with PhRMA Code, AKS/FMV requirements, ACCME standards, GCP requirements and DBV policies
Define systems and cadence for field medical metrics and insights reporting
Partner with Field Medical leadership and IT on CRM/insights tooling and data integrity
Build the U.S. Medical Affairs Operations team, hire and manage direct reports, and establish scalable ways of working, systems and SOPs

Requirements

What you’ll need

Bachelor’s degree in life sciences, business, or related field
12+ years of progressive experience in the biopharmaceutical industry
7+ years in Medical Affairs operations or closely adjacent roles
Direct experience operationalizing Medical Affairs through at least one U.S. product launch
Demonstrated ownership of grants/IME and IIS programs, HCP and vendor contracting, and Medical Affairs budget management
Working knowledge of PhRMA Code, Anti-Kickback Statute, fair-market-value principles, Sunshine Act / Open Payments, ACCME standards, and GCP requirements
Proven ability to design dashboards, KPIs and reporting
Strong financial and analytical fluency, including Excel and familiarity with planning, CRM/insights and contract-management systems
Experience hiring, developing and leading a team
Ability to influence without authority across a matrixed, cross-functional launch organization
Preferred: experience in allergy/immunology, pediatrics, or specialty launches
Preferred: experience in a dual-listed or non-U.S.-headquartered company
Preferred: prior exposure to BLA-stage organizations and inspection-readiness expectations
Project management certification (PMP or equivalent) or formal operational excellence training
Comfortable creating process, policy and infrastructure from a blank page and scaling it
Compliance, financial rigor, cross-functional orchestration, and judgment under ambiguity