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Position Summary:

The Associate Director, Clinical Logistics develops strategies to address complex clinical issues. He/she manages the strategic elements of clinical supplies, clinical study and department budgets, oversight of monitoring and end to end process improvements in clinical study processes and ensuring operating procedures and company policies are followed. Develops and manages and oversees Monitoring, resourcing, and budget for department and all JJV clinical trials worldwide. As spokesperson and technical expert for clinical operations, provides compelling rationale for decisions and presents complex strategies in a clear message.

Using the Manager's conceptual knowledge of all R&D functions, drives innovation within

functional area. Establishes key operating practices for department/project while ensuring cross functional synergy.

Builds cross-functional and cross-departmental support for innovative solutions and

mentors/facilitates successful team behavior. Partners with Clinical Operations, Clinical Scientists to ensure that project deliverables are met.

Manages relationships externally with Strategic Partners, including study sites,

hospitals/surgery centers, universities, research institutions, Vendors and CROs.

Adheres to environmental policy, procedures, and supports department environmental objectives.

Essential Functions/Responsibilities:

• Own processes and information required to execute and support the clinical trial including

• project timelines, resourcing, budget plans, clinical supply management.

• agreements and statements of work (50).

• 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%).

• Responsible for the selection of Contract Resource Organizations (CRO) and oversight of

• 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:

• A minimum of 8+ years' experience in Research & development or Clinical Research in a medical device OR pharmaceutical regulated industry

• A minimum of a Bachelor's degree

• A minimum of 3 years of experience in people management

• Strong communication, organizational, and interpersonal skills.

• Ability to effectively negotiate and influence peers, affiliates, and Regulatory agencies to ensure that regulatory and business needs are met

• Experience in innovative approaches to conduct research globally

Preferred:

• A minimum of 2 years experience in a clinical trial management.

• Complete understanding and application of principles, concepts, and practices of clinical research procedures and Good Clinical Practice (GCP).

• Broad understanding of medical devices/instrumentation used in ophthalmic surgery/optometry.

• Broad based technical knowledge and skills in diverse areas of business (e.g., Operations, QA, laboratory, regulatory, project management, etc.).

This job posting is anticipated to close on 11/04/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The anticipated base salary for this position is $135,000 to $232,000 for Jacksonville and Irvine, CA.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be 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.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

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