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.
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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 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 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 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.
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Required Skills:
Clinical Research, Communication
Preferred Skills:
Good Clinical Practice (GCP), Ophthalmology, People Management