Associate Director, Clinical Operations | Jacksonville, FL

Posted 3 Days Ago
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Jacksonville, FL, USA
Hybrid
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Leads global clinical operations for ophthalmic medical device trials, managing study strategies, timelines, resources, budgets, documentation, CROs, contracts, and regulatory compliance. Oversees study conduct, improves clinical trial processes, collaborates cross-functionally, manages external partners, and mentors study managers. Requires strong clinical research expertise, GCP knowledge, communication, negotiation, and organizational skills, with up to 10% travel and hybrid work in Jacksonville, Florida.
Summary Generated by Built In

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

About VisionFueled 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 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/medtechWe are searching for the best talent for an Associate Director, Clinical Operations to join our J&J Vision team.  This position is based in Jacksonville, FL.Purpose:The Associate Director, Clinical Operations develops strategies to address complex clinical issues. The Associate Director manages the strategic elements of study conduct, ensuring that operating procedures and company policies are followed. The Associate Director develops and manages timelines, resources, and budgets for JJV clinical trials worldwide. As a spokesperson and technical expert for Clinical Operations, the Associate Director provides compelling rationales for decisions and communicates complex strategies clearly.Leads innovation and establishes operating practices across the functional area while fostering cross-functional collaboration and effective team performance. Manages multiple clinical studies across product platforms and directs and mentors study managers to ensure delivery of project objectives. Builds and manages relationships with external strategic partners and ensures compliance with policies, procedures, and departmental objectives.You will be responsible for:
  • Own the processes and information required to execute and support clinical trials, including the clinical trial project plan, project timelines, resource plans, budget plans, clinical study agreements, and statements of work (30%).
  • Be accountable for the preparation and finalization of key clinical documents, including the clinical protocol, informed consent forms, case report forms, training materials, and other essential study documents (20%).
  • Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable regulations and guidelines required to gain approval for testing investigational ophthalmic devices (25%).
  • Lead the selection of contract research organizations (CROs) and oversee contracts, timelines, and budgets, when applicable (10%).
  • Manage and improve clinical trial processes, including benchmarking and leveraging across other J&J companies (10%).
  • Perform other related duties as assigned by management (5%).
Qualifications Required:
  • Minimum of a bachelor’s degree.
  • Minimum of 8 years’ experience in clinical research in a medical device or pharmaceutical regulated industry.
  • Understanding and application of clinical research principles, concepts, procedures, and Good Clinical Practice (GCP).
  • Strong communication, organizational and interpersonal skills.
  • Ability to negotiate effectively and influence peers, affiliates, and regulatory agencies to ensure that regulatory and business needs are met.
  • Ability to work hybrid out of the Jacksonville, FL office location.
  • Up to 10% business travel may be required.
Preferred:
  • Master’s or PhD degree in a scientific discipline.
  • Minimum of 2 years’ experience as a clinical research associate.
  • People management experience.
  • Broad understanding of ophthalmology and medical devices or instrumentation used in ophthalmic surgery.
  • Broad-based technical knowledge and skills across diverse business areas (e.g., Operations, Quality Assurance, laboratory, Regulatory, and project management).
  • Strategic and tactical clinical and business knowledge to support product approvals and maintenance of legal marketing status.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.#LI-JS3#LI-hybrid



Required Skills:

Clinical Research, Communication

Preferred Skills:

Good Clinical Practice (GCP), Ophthalmology, People Management

Skills Required

  • Bachelor's degree
  • At least 8 years of clinical research experience in a medical device or pharmaceutical regulated industry
  • Understanding and application of clinical research principles, concepts, procedures, and Good Clinical Practice
  • Strong communication, organizational, and interpersonal skills
  • Ability to negotiate effectively and influence peers, affiliates, and regulatory agencies
  • Ability to work hybrid from the Jacksonville, Florida office
  • Up to 10% business travel
  • Master's or PhD degree in a scientific discipline
  • At least 2 years of clinical research associate experience
  • People management experience
  • Broad understanding of ophthalmology and ophthalmic medical devices or surgical instrumentation
  • Technical knowledge across Operations, Quality Assurance, laboratory, Regulatory, and project management
  • Strategic and tactical clinical and business knowledge supporting product approvals and legal marketing status

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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