Janssen Research & Development, LLC, is recruiting for an Associate Director, Global Clinical Operations – U.S. Immunology. This position can be located remotely within the United States.

The Associate Director, Global Clinical Operations – U.S. Immunology is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. Supports Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Key Responsibilities:

• Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
• Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local Global Clinical Operations (GCO) management accordingly.
• Support the flexible resourcing model and collaborate with flex resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
• Interview, hire, develop and train staff.
• Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports’ training compliance.
• Support direct reports in issue resolution and communication with involved stakeholders.
• Support local implementation of organizational changes and effectively communicate when priorities shift.
• Review and approve expenses in compliance with the company policies.
• Demonstrate leadership behaviors in alignment with J&J Leadership Imperatives.
• Foster an environment that encourages sharing of ideas, information, and best practices (internal and external to the organization).
• Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
• Support execution of long-term strategy in alignment with GCDO and Janssen R&D strategies to position the country for success.
• Define, execute or support of long-term strategy in alignment with GCO, GCDO and Janssen R&D strategies to position the local and global GCO organization for success.
• Oversight of execution and monitoring of clinical trials through all phases (from feasibility to closeout) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
• Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
• Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct, and health care compliance breach.
• Contribute to CAPA and issue resolution in accordance with required timelines.
• Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
• Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
• Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
• Support regular metrics review and drive necessary follow-up actions.
• Contribute to development, evaluation and implementation of new processes and systems to improve study management.
• Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
• Foster a culture of continuous improvement and innovation within the local GCO team.
• Model Credo based culture within the local Global Clinical Operations team.

Qualifications

Qualifications

Education:

• Bachelor's degree required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

Experience and Skills

Required:

• Minimum of 8 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
• At least 2 years of direct line management experience (medium to large size team of direct reports) required.
• Effective communication and leadership skills and proven ability to foster team productivity and cohesiveness.
• Skilled in leading, hiring, training, developing, and evaluating people.
• Solid decision making and financial management skills.
• Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.
• Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
• Ability to synthesize and evaluate data generated from various reports and sources.
• Demonstrated skills in effective communication with various internal and external stakeholders (e.g., investigational sites, ethics committees, health authorities, etc.).
• Flexible mindset and ability to work in a fast-changing environment and operates under limited supervision.
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.

Preferred:

• Immunology experience strongly preferred.

• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook)

• Proficiency with CTMS, RAVE, Veeva Vault systems

Other:

• Proficient in the English language

• Up to 20% travel, primarily for meetings

The anticipated base pay range for this position in San Francisco Bay Area, CA is $150,300 to $259,210. The anticipated base pay range for this position in all other US locations is $131,000 to $225,400. 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)).This position is eligible to participate in the Company’s long-term incentive program. 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
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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 .

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