Hybrid Director, Clinical Science

at OneTrust

• Job title: Director, Clinical Science
• Job type: Full Time
• Experience level: Lead
• Salary: $150,000 - $251,850 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Irvine, United States

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