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About the role
- Director Clinical Science leading quality clinical studies in support of new product development at Johnson & Johnson. Overseeing regulatory communications and mentoring clinical research teams.
Responsibilities
- Lead the Clinical Science organization to ensure the design, execution, and reporting of compliant, quality clinical studies in support of new product development while ensuring patient safety
- Act as medical and/or technical expert in communications with FDA and other Regulatory agencies worldwide
- Oversees post market clinical activities for product portfolio
- Defines and implements department or platform strategies and serves as an authority to the business
- Identifies and manages risks and business needs
- Ensures the development and implementation of leading-edge products and clinical measurement techniques internally/across sites/platforms
- Develops and ensures departmental or platform initiatives maximize customer value at lowest cost
- Sponsors departmental and cross-functional team development
- Provides project leadership or participates as a team member on major initiatives that have high impact to the business
- Applies influence across departments and the business
- Accountable for organizational depth to meet present and future business needs
- Fosters relationships with research organizations, academic institutions, key opinion leaders (KOL’s), and organizations worldwide
- Design and implement clinical research strategies that align with product development and regulatory requirements
- Lead and mentor a team of clinical scientists and researchers, fostering a collaborative environment that encourages innovation and professional development
- Work closely with cross-functional teams, including R&D, Regulatory, Marketing, and Quality, to support project prioritization, clinical trial design and execution, regulatory submissions, and launch-related activities
- Oversee the planning, execution, analysis, and reporting of clinical studies, ensuring adherence to Good Clinical Practice and regulatory guidelines
- Engage with key opinion leaders, clinical investigators, and academic researchers to establish partnerships and gain insights into emerging trends in ophthalmology
- Represent J&J Vision at scientific meetings and external conferences
Requirements
- Advanced degree (OD, MD, PhD, or equivalent) in life sciences, medicine, or a related field is required
- A minimum of 10 years of relevant clinical research experience with at least 5 years in a leadership role within the medical device, biotech, or pharmaceutical industry
- Minimum 5 years of people management experience
- Demonstrated technical/clinical product development experience required
- In-depth knowledge of ophthalmic clinical trial design, regulatory affairs, and Good Clinical Practice
- Strong analytical, organizational, and project management skills
- Exceptional communication, negotiation, and interpersonal abilities
- Demonstrated record in relationship-building with internal partners
- Demonstrated ability to build successful relationships with key opinion leaders and investigators globally
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
- consolidated retirement plan (pension) and savings plan (401(k))
- long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 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
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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