Senior Director, U.S. Medical Affairs Operations

Description :

DBV is preparing for the anticipated 2027 U.S. launch of Viaskin and is converting a clinical-development Medical Affairs organization into a launch-ready one. Medical strategy, field medical, and scientific engagement are scaling at once — and today the operating infrastructure behind them (planning cadence, compliant grant and IIS review, contracting, budget discipline, transparency reporting, and performance metrics) does not yet exist at launch scale.

The Senior Director, U.S. Medical Affairs Operations owns that infrastructure. The role is the operational backbone of U.S. Medical Affairs: it turns the medical strategy into an executable, funded, compliant and measurable plan, gives the Head of Global Medical Affairs line-of-sight across every workstream, and ensures Medical Affairs shows up prepared and on time at cross-functional launch readiness governance. Success means a Medical Affairs function that can execute the launch without operational surprises, and that can withstand audit and inspection scrutiny from day one.

Location :Warren, New Jersey - minimum 3 days on site (travel ~20% including congresses and advisory boards)

Salary Range :$250-300k

Key Responsibilities :

1. 1. Strategic and tactical planning
   • Build and own the U.S. Medical Affairs strategic/tactical plan (1H/2H), translating the medical strategy into prioritized projects with owners, milestones, budgets and KPIs.
   • Run the Medical Affairs planning cadence — annual plan, mid-year refresh, monthly leadership reviews — and maintain a single integrated view of all MA workstreams.
   • Design and maintain the Medical Affairs dashboard and project-tracking mechanism; surface risks, slippage and resource conflicts to the Head of Global Medical Affairs early.
2. 2. Launch readiness governance
   • Serve as Medical Affairs’ operational lead for the cross-functional Launch Readiness Review (LRR): define MA attendance and presenters, manage the flow of information into the LRR, set the cadence of pre-reads with the MA leadership team, and own the upkeep of MA launch-readiness materials.
   • Partner with Commercial, Market Access, Regulatory, Pharmacovigilance and Compliance to ensure MA deliverables are integrated into the overall launch plan and critical path.
3. 3. Scientific engagement operations
   • Map and operationalize the U.S. advisory board plan (2026–2027): needs assessment, compliant participant selection and fair-market-value contracting, logistics, documentation and insights capture.
   • Oversee congress planning and medical meeting operations in coordination with Medical Communications and Field Medical.
4. 4. Grants and investigator-initiated studies (IIS)
   • Stand up the compliant end-to-end process for medical education grants and IIS: policy/SOP and business-practice documentation, review-committee charter, intake and review criteria, contracting, milestone and payment tracking, and close-out.
   • Chair or coordinate the Grants/IIS review committee with Legal, Compliance and Finance; maintain the audit trail and reporting.
5. 5. Contracting and vendor management
   • Triage all Medical Affairs contracting through operations — HCP consulting, vendors, agencies, research collaborations — to maintain oversight, increase visibility, and ensure correct budget coding.
   • Own vendor selection, onboarding, performance management and renewal for MA service providers in partnership with Procurement and Legal.
6. 6. Budget and financial management
   • Own the U.S. Medical Affairs budget: itemized spend plan by vendor, project lead, description and phasing; monthly accruals; reforecasts (RFCST 1/2/3); and long-range plan input in partnership with FP&A.
   • Deliver budget-to-forecast variance reporting and spend transparency to the Head of Global Medical Affairs and the CFO organization.
7. 7. Compliance and transparency reporting
   • Capture and report all transfers of value (TOV) for the Medical Affairs department under the Physician Payments Sunshine Act / Open Payments and applicable state laws, in coordination with Compliance.
   • Ensure MA operations adhere to PhRMA Code, AKS/FMV requirements, ACCME standards for independent medical education, GCP requirements for IIS, and DBV policies; ensure inspection- and audit-readiness of MA operational records.
8. 8. Field medical metrics and insights
   • Define the template, systems and cadence for capturing and collating field medical metrics (MSL interactions — face-to-face vs. virtual — and medical insights) and convert them into actionable reporting for MA and cross-functional leadership.
   • Partner with Field Medical leadership and IT on CRM/insights tooling and data integrity.
9. 9. Team leadership and capability building
   • Design and build the U.S. MA Operations team through launch (e.g., grants/IIS and contracting; budget and analytics); hire, develop and manage direct reports; set performance objectives aligned to the launch plan.
   • Establish scalable ways of working, systems and SOPs that allow Medical Affairs to grow from pre-launch to a full commercial-year operating model without loss of control.

Qualifications :

Required

• Bachelor’s degree in life sciences, business, or related field; advanced degree (MBA, MS, PharmD, PhD) preferred.
• 12+ years of progressive experience in the biopharmaceutical industry, including 7+ years in Medical Affairs operations or closely adjacent roles (medical strategy/planning, field medical excellence, scientific operations).
• Direct experience operationalizing Medical Affairs through at least one U.S. product launch — ideally a first launch at an emerging or mid-sized company where the infrastructure was built, not inherited.
• Demonstrated ownership of grants/IME and IIS programs, HCP and vendor contracting, and Medical Affairs budget management (forecasting, accruals, LRP).
• Working knowledge of U.S. healthcare compliance frameworks governing Medical Affairs: PhRMA Code, Anti-Kickback Statute and fair-market-value principles, Sunshine Act / Open Payments, ACCME standards, and GCP requirements for investigator-sponsored research.
• Proven ability to design dashboards, KPIs and reporting that leadership actually uses; strong financial and analytical fluency (Excel; familiarity with planning, CRM/insights and contract-management systems).
• Experience hiring, developing and leading a team, and influencing without authority across a matrixed, cross-functional launch organization.

Preferred

• Experience in allergy/immunology, pediatrics, or a specialty launch with a significant field medical footprint.
• Experience in a dual-listed or non-U.S.-headquartered company; comfort partnering with a European HQ on global planning and governance.
• Prior exposure to BLA-stage organizations and inspection-readiness expectations.
• Project management certification (PMP or equivalent) or formal operational excellence training.

Behavioral skills :

• Curiosity: Keep on exploring uncharted territories. Always ask "why?" and more importantly "why not?"

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.

• Builder mindset. Comfortable creating process, policy and infrastructure from a blank page, then scaling it; equally willing to run the process personally before a team exists.

• Compliance as a design principle. Treats transparency, FMV and grant/IIS governance as enablers of speed, not obstacles; knows where the lines are and documents to an inspection standard.

• Financial rigor. Owns the numbers; can defend a forecast to the CFO organization and explain variance in business terms.

• Cross-functional orchestration. Credible with Commercial, Market Access, Regulatory, Compliance and Finance; keeps Medical Affairs visible, prepared and on time in launch governance.

• Judgment under ambiguity. Prioritizes ruthlessly in a resource-constrained, pre-commercial environment and escalates the right issues early.