Principal Clinical Research Scientist Non-MD

Johnson & Johnson•West Chester, PA

8d•Hybrid

About The Position

The Principal Clinical Research Scientist - Sports Medicine provides scientific leadership for the development and execution of global clinical evidence generation and dissemination strategies supporting New Product Development (NPD) and Life Cycle Management (LCM) programs within the Medical Device Group. This role serves as a key strategic partner across Clinical R&D, Medical Affairs, Regulatory Affairs, Health Economics & Market Access (HEMA), Marketing, and R&D to ensure evidence plans support clinical, regulatory, reimbursement, and commercial objectives.

Requirements

Bachelor's degree in Biological Sciences, Health Sciences, Engineering, or a related scientific discipline.
Experience with development and application of innovative evidence generation methodologies, including integration of real-world data (RWD), external control cohorts, synthetic controls, and hybrid study designs that combine RWD and prospective clinical study data to support regulatory submissions, product approvals, label expansions, and lifecycle management activities.
Experience managing pre-market and post-market clinical studies to support regulatory approval and market adoption of medical device technologies.
Minimum 8 years of clinical research, clinical development, or scientific leadership experience within the medical device, pharmaceutical, or healthcare industry.
Demonstrated experience leading clinical evidence generation strategies, clinical studies, and scientific communications within Sports Medicine and/or Orthopedic Medical Devices, including soft tissue repair, sports biologics, extremities, arthroscopy, and related technologies.
Strong understanding of Good Clinical Practice (GCP), global clinical research regulations, and applicable standards.
Experience developing and executing clinical evidence strategies supporting product development and commercialization.
Demonstrated ability to influence cross-functional teams in a matrixed environment.
Excellent scientific communication, presentation, and technical writing skills.

Nice To Haves

Advanced degree (MS, PhD, PharmD, MD, or equivalent).
Experience supporting global medical device development programs.
Experience with regulatory submissions and interactions with health authorities and notified bodies.
Publication and scientific communication experience.

Responsibilities

Clinical Evidence Strategy: Lead the development and execution of global Evidence Generation Strategies (EGS) and Evidence Dissemination Strategies (EDS) that support product development, regulatory requirements, market access, and commercialization objectives. Ensure alignment of evidence strategies with business priorities and regional clinical needs through collaboration with global and regional stakeholders. Identify evidence gaps and recommend appropriate clinical research approaches to support NPD and LCM initiatives.
Clinical Research Leadership: Provide scientific leadership for the design and conduct of clinical studies, registries, and other evidence-generation activities. Partner with Clinical Operations to support effective execution of clinical programs, ensuring delivery consistent with project objectives, timelines, budgets, and applicable regulations. Provide scientific oversight and guidance throughout study planning, execution, analysis, and reporting.
Scientific Communication & Dissemination: Lead interpretation and communication of clinical evidence through study reports, scientific publications, conference presentations, Clinical Evaluation Reports (CERs), and other scientific communications. Support development of evidence-based value dossiers and technical summaries for market access, reimbursement, and commercial stakeholders.
Regulatory & External Scientific Engagement: Contribute scientific expertise to interactions with regulatory agencies, notified bodies, ethics committees, and other external stakeholders. Support regulatory submissions and responses related to clinical evidence and investigational studies. Develop and maintain relationships with key opinion leaders, investigators, professional societies, and research collaborators.
Cross-Functional Collaboration: Partner effectively across Clinical R&D, Medical Affairs, Regulatory Affairs, HEMA, R&D, Marketing, Quality, and other functions to ensure integrated evidence planning and execution. Communicate scientific insights, emerging evidence, risks, and opportunities to project teams and management.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
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