Director Clinical Science

Johnson & Johnson•Irvine, CA

1d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com About Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for a Director Clinical Science. The role is based on either the Irvine, CA or Milpitas, CA campuses. Purpose: Director Clinical Science will 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.

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

Nice To Haves

Preferred Area of Study: Optometry, Ophthalmology, Vision Science
Experience taking product through development, regulatory approval and launch
3+ years in medical device, biotech, or pharmaceutical industry
3+ years of ophthalmic patient interaction in practice, academic or research

Responsibilities

Masters Complexity - Defines and implements department or platform strategies and serves as an authority to the business. Understands the interrelationship among functions and with other business areas. Serves as technical representative for the department.
Innovation - Identifies and manages risks and business needs. Ensures the development and implementation of leading-edge products and clinical measurement techniques internally/across sites/platforms.
Customer Focus - Develops and ensures departmental or platform initiatives maximize customer value at lowest cost.
Interdependent Partnering - Sponsors departmental and cross-functional team development. Removes barriers. Provides project leadership or participates as a team member on major initiatives that have high impact to the business. Key member of clinical sciences leadership team. Applies influence across departments and the business.
Organizational & People Development - Accountable for organizational depth to meet present and future business needs, looking across J&J companies. Serves as a change agent for global effectiveness.
External Focus - Fosters relationships with research organizations, academic institutions, key opinion leaders (KOL’s), and organizations worldwide and represents J&J Vision at external panels / conferences.
Compliance - Adheres to environmental policy, procedures, and supports department environmental objectives.
Credo - Engages in Credo-based decision-making.
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.
Prepare and review clinical sections for regulatory submission and communicate with regulatory agencies as needed.
Perform other related duties as assigned by management.

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
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