Vice-President, Clinical Affairs

Johnson & Johnson

Johnson & Johnson MedTech VP leading clinical evidence strategy for surgical technologies. Directing global studies, regulatory evidence, analytics, and multidisciplinary clinical teams.

Posted 8/17/2026full-timeRaritan • New Jersey, Ohio • 🇺🇸 United StatesSeniorLead💰 $218,000 - $401,350 per yearWebsite

Core Competencies

Role fit

Core 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 submissions, clinical trial design, and multidisciplinary team leadership. Proven ability to manage complex global clinical programs while ensuring compliance with GCP and regulatory standards.

Highest-signal resume keywords

Clinical Development StrategyRegulatory Submissions ManagementMultidisciplinary Team LeadershipBiostatistics and Data Science ExpertiseClinical Trial Design Knowledge

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

Clinical Trial DesignBiostatisticsData AnalysisRegulatory FilingsEvidence GenerationStatistical ProgrammingRisk-Based MonitoringData IntegrityBudget ManagementKPI Tracking

Soft Skills

Excellent CommunicationStrategic ThinkingInfluencing SkillsCollaborative LeadershipCross-Functional Collaboration

Tools & Technologies

AI/ML AnalyticsData Science WorkflowsHealth EconomicsHTA Evidence RequirementsDigital Endpoints

Certifications & Qualifications

Advanced Degree (MS, MD, PhD, PharmD)MBA (Preferred)

Industry Keywords

Clinical OperationsPivotal TrialsPost-Market StudiesRegulatory AuthoritiesMedical DevicesCombination ProductsBiologicsReal-World EvidenceDecentralized TrialsPatient-Centered Mindset

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Define and execute the 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 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 submissions
Ensure clinical quality systems and GCP-compliant processes, risk-based monitoring, data integrity, safety reporting, and audit readiness
Translate clinical evidence into value communication for clinicians, payers, and customers; support publications and scientific communications
Manage budgets, resource allocation, vendor selection and oversight, and program timelines across multiple portfolios
Develop talent through hiring, coaching, performance management, succession planning, and cross-functional collaboration
Track 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

Advanced degree required: 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 and ability to oversee multiple outsourced relationships
Track record of delivering programs on time and on budget with measurable regulatory/market outcomes
Excellent communication and influencing skills; comfortable presenting to executive leadership and external stakeholders
Strong business acumen and strategic thinking
Ability to balance scientific rigor with commercial and regulatory needs
Ability to travel globally 20–40% depending on pipeline activities and external meetings
Preferred: experience in relevant therapeutic areas or product modalities such as 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
Appreciation 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 leadership
High integrity, patient-centered mindset, and commitment to ethical research conduct

Benefits

Comp & perks

Annual performance bonus
Pension plan
401(k) savings plan
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year
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 the 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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and accommodations for applicants with disabilities