Vice-President Clinical Affairs

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: People Leader All Job Posting Locations: Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote (US) Job Description: Title: VP Clinical Affairs Location: Preferred locations include Raritan, NJ, or Cincinnati, OH. Other J&J MedTech locations will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent to join our Surgery team as a Vice President Clinical Affairs preferably in Raritan, NJ, or Cincinnati, OH. Other J&J MedTech locations will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: Senior leader responsible for defining and executing the clinical and evidence-generation strategy across the product portfolio. Leads a multidisciplinary organization that includes Evidence Generation Strategy, Clinical Research, Clinical Operations, Clinical Evaluation, Biostatistics & Data Science, and Pre Clinical teams. Partners with Regulatory, Quality, Medical Affairs, Commercial, and Product Development to deliver high-quality clinical evidence that supports regulatory submissions, health technology assessment (HTA), reimbursement, and optimal patient outcomes. Set clinical strategy and evidence-generation plans that align with business objectives, product strategy, regulatory requirements, and payer needs across development lifecycle (pre-clinical → clinical → post-market). Lead and grow an integrated, high-performing clinical organization covering clinical research, operations, clinical evaluation/medical writing, biostatistics, data science, and pre-clinical functions. Oversee design, execution, and delivery of clinical studies (first-in-human, pivotal, registries, observational/RWE, post-market surveillance), ensuring scientific rigor, ethical conduct, regulatory compliance, and on-time delivery. Provide scientific and operational leadership for statistical planning, data analysis, data management, and modern analytics (including AI/ML where applicable) to produce robust, reproducible evidence. Support relationships with external stakeholders: regulatory agencies, key opinion leaders, global investigators/sites, Contract Research Organizations (CROs), academic partners, and HTA bodies. Coordinate clinical input for regulatory submissions (IDE, PMA/510(k)/CE/other regional filings) and ensure clinical content for technical documentation and labeling is accurate and defensible. Ensure clinical quality systems and GCP-compliant processes are in place; champion risk-based monitoring, data integrity, safety reporting, and audit readiness. Partner with Medical Affairs and Commercial to translate clinical evidence into value communication for clinicians, payers, and customers; support publication and scientific communications strategy. Manage budgets, resource allocation, vendor selection and oversight, and program timelines across multiple portfolios. Develop talent through hiring, coaching, performance management, succession planning, and promoting cross-functional collaboration. Track key performance indicators (enrollment rates, milestones, data quality metrics, timelines, budget adherence, regulatory outcomes) and report progress to executive leadership and the Board as required. Accelerate speed to value and optimize resource utilization according to business objectives Qualifications / Requirements: 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. Demonstrated experience leading multidisciplinary teams and managing complex global c-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 (e.g., FDA, EMA) and supporting regulatory filings and inspections. Proven vendor/CRO management experience and ability to oversee multiple outsourced relationships. Track record of successfully 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, strategic thinking, and ability to balance scientific rigor with commercial and regulatory needs. Global travel typically 20–40% depending on pipeline activities and external meetings. Preferred Experience in the relevant therapeutic area(s) or product modality (medical devices, combination products, or biologics) MBA or other business degree is a plus. Familiarity with health economics/HTA evidence requirements, payer evidence generation, and value dossiers. Practical knowledge of modern clinical trial approaches: adaptive designs, decentralized trials, digital endpoints, registries, synthetic controls, and RWE methodologies. Hands-on exposure to statistical programming environments and data science workflows; appreciation of data governance and reproducible research principles. Prior experience with global regulatory submissions (PMA/CE/IDE/510k) and post-approval study commitments. Other Leadership competencies Strategic vision and ability to translate strategy into executional plans. Collaborative, cross-functional leadership and stakeholder management. Change agent: drives process improvements and fosters innovation. High integrity, patient-centered mindset, and commitment to ethical research conduct. Success metrics (examples) Delivery of pivotal study milestones within agreed timelines and budgets. Quality and completeness of regulatory submissions supported by clinical evidence. Number and impact of peer-reviewed publications and scientific presentations. Effective development and retention of high-performing clinical teams. Improvement in enrollment rates, data quality metrics, and time-to-market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gende