Vice President, Evidence Strategy & Operations overseeing clinical research for Orthopedic team at Johnson & Johnson. Driving evidence generation and operations strategy to enhance innovative treatments.
Responsibilities
Develop and execute comprehensive evidence generation and dissemination strategy.
Establish scalable organizational structure, processes, and governance for compliant multi‑site clinical operations.
Oversee all aspects of clinical research activation, contracting, budgeting, and compliance.
Lead site selection, contracting, budgeting, and strategic planning across hospitals, outpatient centers, and investigator sites.
Strengthen and mature core clinical functions (clinical operations, regulatory, data management, monitoring, site management, QA, vendor management, etc.).
Advance centralized operations for data management, monitoring, and regulatory oversight.
Identify, evaluate, and onboard new research sites and investigators to broaden organizational reach.
Provide leadership and oversight for all clinical programs, ensuring scientific rigor, regulatory compliance, and alignment with patient‑focused and business objectives.
Manage clinical trial design, execution, monitoring, data analysis, and interpretation to demonstrate safety, efficacy, and clinical utility.
Serve as the primary clinical liaison to KOLs, investigators, CROs, regulatory agencies, reimbursement experts, and clinical partners.
Collaborate with engineering, regulatory, and commercial teams to translate clinical insights into product development, regulatory, reimbursement, and commercialization strategies.
Partner with finance to manage clinical budgets, forecast resource needs, and support operational planning.
Requirements
At least a master’s degree (e.g., MBA, MHA, etc)
10+ years of business leadership experience, including at least 5 years in senior roles within a CRO, SMO, or sponsor‑side research operations.
Deep expertise in device trial operations.
Proven ability to manage partnerships across outpatient centers, hospitals, and integrated health systems.
Strong knowledge of FDA and international regulations and GCP requirements for device trials.
Entrepreneurial mindset with the ability to thrive in growth‑stage environments.
Exceptional communication, relationship management, and operational strategy competencies.
Preferred experience in orthopedic or similar device domains.
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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
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