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
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