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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and executing integrated U.S. Medical Plans, with a strong focus on clinical trial design, Real World Evidence generation, and strategic alignment with commercial objectives. Proven ability to lead cross-functional teams and communicate complex scientific data effectively to diverse stakeholders.
Highest-signal resume keywords
Medical Affairs Strategy DevelopmentClinical Trial Design and ExecutionReal World Evidence GenerationAI Applications in Clinical Data AnalysisRegulatory Knowledge (FDA, OIG, OPDP)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial MethodologyMedical Strategy ExecutionPharmacovigilance PrinciplesData Interpretation and ReportingEvidence SynthesisStatistical Analysis PlansProtocol DevelopmentInvestigator Sponsored Trial ManagementBudget ManagementScientific Communication
Soft Skills
Effective Communication SkillsRelationship BuildingLeadership in Matrix OrganizationsAdaptability in Fast-Moving EnvironmentsCritical Evaluation of Insights
Tools & Technologies
Digital Health Data SourcesAnalytics PlatformsAI-Driven Literature AnalysisClinical Data Interpretation ToolsMedical Engagement Planning Tools
Certifications & Qualifications
Advanced Degree (MD, PhD, PharmD, DO)
Industry Keywords
Allergy/ImmunologyU.S. Pharmaceutical MarketClinical ResearchRegulatory ProcessesMedical AffairsReal World Evidence MethodologiesClinical Safety SurveillanceScientific Advisory BoardsKey Opinion Leaders EngagementOrganizational Change Initiatives
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Develop and execute an integrated U.S. Medical Plan covering Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research
- Manage the annual medical plan budget
- Translate medical strategy into actionable tactical plans and communicate progress to leadership, Core Team, and execution partners
- Align medical strategy with clinical development and commercial objectives and adapt it to U.S. needs
- Provide medical leadership and scientific input to Clinical, Commercial, Market Access, Regulatory, and Sales functions
- Partner with Field Medical, HEVA, Market Access, Marketing, Legal, and Regulatory teams
- Address evidence gaps and support payer-relevant data needs
- Manage external stakeholder relationships and contribute to medical engagement planning and budget oversight
- Support U.S. Phase IIIB–IV clinical programs, including protocol development, case report forms, statistical analysis plans, and study-data reporting
- Oversee clinical studies under GCP/ICH guidelines and company standards
- Review and approve Investigator Sponsored Trial concepts and protocols
- Identify and oversee post-marketing clinical trials and registry needs
- Ensure trial data is publicly disclosed accurately and promptly
- Develop research collaborations addressing clinical questions
- Lead AI and advanced data analytics applications for evidence synthesis, signal detection, and unmet-need identification
- Guide AI-driven literature analysis, clinical-data interpretation, and scientific communication
- Oversee Real World Evidence study design, generation, and integration into the U.S. medical plan
- Communicate RWE findings and incorporate them into strategy and publication planning
- Build relationships with Key Opinion Leaders, researchers, and clinical experts
- Lead medical and scientific advisory boards
- Represent Sanofi at congresses, advisory boards, and scientific meetings
- Provide disease-state and product training
- Review and approve promotional, medical, regulatory, safety, scientific, and commercial materials
- Review independent medical education grant applications and employee training materials
- Partner with U.S. Drug Safety on adverse-event management, safety surveillance, and signal communication
- Identify and escalate Product Alerts to the Core Team
Requirements
What you’ll need- Advanced degree; MD preferred; PhD, PharmD, or DO considered
- Minimum 5 years of clinical experience in Allergy/immunology or minimum 5 years of Medical Affairs experience in immunology strongly preferred
- Track record developing and executing medical strategies in the U.S. pharmaceutical market
- Experience in Medical Affairs launch and lifecycle management activities
- Experience in clinical trial design and execution
- Deep knowledge of the relevant therapeutic area
- Strong scientific and clinical judgment
- Understanding of clinical trial methodology, including design, execution, data interpretation, and reporting
- Knowledge of pharmacovigilance principles and U.S. regulatory processes
- Familiarity with FDA, OIG, OPDP, PhRMA, ICMJE, and ISPOR regulations and guidance
- Working knowledge of AI applications in clinical data analysis, evidence synthesis, and medical decision-making
- Ability to critically evaluate AI-generated insights
- Familiarity with digital health data sources and analytics platforms
- Experience designing, generating, analyzing, and applying Real World Evidence
- Familiarity with RWE methodologies and claims, EHR, and patient-reported outcome data sources
- Ability to communicate RWE findings to clinical, payer, and regulatory audiences
- Ability to lead cross-functional teams and influence decisions without direct authority in a matrix organization
- Strong internal and external relationship-building track record
- Effective written, verbal, and presentation communication skills
- Ability to translate complex scientific data for diverse audiences
- Ability to operate in ambiguous, fast-moving environments and prioritize and adapt plans
- Experience leading or supporting organizational change initiatives
- Highest standards of integrity, ethics, and scientific rigor
- Experience working across diverse cultures and global teams
Benefits
Comp & perks- Supportive, future-focused team
- Opportunities for talent growth and career advancement through promotion or lateral move, at home or internationally
- Thoughtful rewards package
- High-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
- Patient-informed drug development
- Work with cutting-edge AI, data, and digital platforms
- Employee benefit programs
