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Vice President, Clinical Affairs
Johnson & JohnsonVP Clinical Affairs leading clinical strategy and evidence generation for Johnson & Johnson MedTech surgical technologies. Overseeing global studies, regulatory submissions, multidisciplinary teams, and patient-outcome evidence.
Posted 8/17/2026full-timeRaritan • New Jersey, Ohio • 🇺🇸 United StatesSeniorLead💰 $218,000 - $401,350 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development and evidence generation, with a strong focus on regulatory compliance, strategic planning, and cross-functional leadership. Proven ability to manage complex clinical programs and deliver measurable outcomes while ensuring data integrity and quality.
Highest-signal resume keywords
Clinical Development StrategyRegulatory Submissions ManagementBiostatistics and Data ScienceMultidisciplinary Team LeadershipClinical Trial Design
ATS Keywords
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Hard Skills
Clinical Trial DesignBiostatisticsData AnalysisRegulatory FilingsEvidence GenerationStatistical ProgrammingData GovernanceRisk-Based MonitoringClinical Evaluation ReportsReal-World Evidence Generation
Soft Skills
Excellent CommunicationStrategic ThinkingInfluencing SkillsCollaborative LeadershipProcess Improvement Mindset
Tools & Technologies
AI/ML AnalyticsData Science WorkflowsVendor Management SystemsClinical Quality SystemsGCP-Compliant Processes
Certifications & Qualifications
Advanced Degree (MS, MD, PhD, PharmD)MBA (Preferred)
Industry Keywords
Medical DevicesCombination ProductsBiologicsHealth EconomicsHTA Evidence RequirementsPayer Evidence GenerationPost-Market SurveillanceGlobal Regulatory AuthoritiesIDE, PMA, CE, 510(k)Patient-Centered Research
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Define and execute clinical and evidence-generation strategy across the product portfolio
- Lead a multidisciplinary organization spanning evidence generation, clinical research, clinical operations, clinical evaluation, biostatistics, data science, and pre-clinical functions
- Partner with Regulatory, Quality, Medical Affairs, Commercial, and Product Development teams
- Set clinical strategy and evidence-generation plans across the pre-clinical, clinical, and post-market lifecycle
- Oversee first-in-human, pivotal, registry, observational/RWE, and post-market surveillance studies
- Provide scientific and operational leadership for statistical planning, data analysis, data management, and modern analytics including AI/ML where applicable
- Manage relationships with regulatory agencies, key opinion leaders, investigators, sites, CROs, academic partners, and HTA bodies
- Coordinate clinical input for IDE, PMA/510(k), CE, and other regional regulatory filings
- Ensure clinical quality systems, GCP-compliant processes, risk-based monitoring, data integrity, safety reporting, and audit readiness
- Translate clinical evidence into value communication for clinicians, payers, and customers
- Manage budgets, resource allocation, vendor oversight, and program timelines across multiple portfolios
- Develop talent through hiring, coaching, performance management, succession planning, and cross-functional collaboration
- Track clinical KPIs and report progress to executive leadership and the Board as required
- Accelerate speed to value and optimize resource utilization
Requirements
What you’ll need- Required advanced degree: MS, MD, PhD, PharmD, or equivalent
- 12+ years of progressive experience in clinical development, clinical operations, biostatistics/data science, or related areas
- At least 6 years in senior leadership roles
- Experience leading multidisciplinary teams and managing complex global clinical programs, including pivotal trials and post-market studies
- Strong knowledge of clinical trial design, biostatistics, clinical evaluation reports, pre-clinical-to-clinical translation, and real-world evidence generation
- Experience interacting with regulatory authorities such as FDA and EMA and supporting regulatory filings and inspections
- Vendor/CRO management experience
- Track record of delivering programs on time and on budget with measurable regulatory or market outcomes
- Excellent communication and influencing skills, including executive and external presentations
- Strong business acumen and strategic thinking
- Ability to balance scientific rigor with commercial and regulatory needs
- Willingness to travel globally 20–40% depending on pipeline activities and external meetings
- Preferred: relevant therapeutic area or product-modality experience in medical devices, combination products, or biologics
- Preferred: MBA or other business degree
- Familiarity with health economics/HTA evidence requirements, payer evidence generation, and value dossiers
- Knowledge of adaptive designs, decentralized trials, digital endpoints, registries, synthetic controls, and RWE methodologies
- Exposure to statistical programming environments and data science workflows
- Knowledge of data governance and reproducible research principles
- Experience with global regulatory submissions including PMA, CE, IDE, and 510(k), and post-approval study commitments
- Strategic vision and ability to translate strategy into executional plans
- Collaborative, cross-functional leadership and stakeholder management
- Process improvement and innovation mindset
- High integrity, patient-centered mindset, and commitment to ethical research conduct
Benefits
Comp & perks- Annual performance bonus eligibility
- Pension plan
- 401(k) savings plan
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; Colorado employees – 48 hours; Washington employees – 56 hours
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process and disability accommodation support