Manager Clinical Operations, Oncology

$139,000 - $224,825/Yr

Johnson & Johnson - Oklahoma City, OK

Full-time - Manager

Oklahoma City, OK

Chemical Manufacturing

About the position

The Manager Clinical Operations, Oncology at Johnson & Johnson is responsible for the operational management and successful execution of clinical trials within the oncology therapeutic area. This role involves overseeing resource allocation, ensuring compliance with regulations, and managing a team of Local Trial Managers and Clinical Trial Assistants. The position emphasizes effective issue management, innovative solutions, and alignment of local goals with organizational objectives, all while fostering a culture of continuous improvement and collaboration.

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.
• Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors.
• Accountable for the acquisition of new talents and development of human resources.
• Guide direct reports in issue resolution and communication with involved stakeholders.
• Lead organizational changes and effectively communicate on priority shifts as required.
• 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.
• Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
• Define, execute or support of long term strategy in alignment with GCO, GD and JJIM R D strategies.
• Oversight of execution and monitoring of clinical trials through all phases and ensuring inspection-readiness.
• Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP and other procedural documents.
• Accountable for appropriate and timely issue escalation and reporting 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.
• Develop country capabilities for an effective study placement within assigned therapeutic area.
• Accountable for robust feasibility process and oversight of site selection.
• Review operational and quality metrics regularly and drive follow-up actions as appropriate.
• Drive innovative solutions and process improvements for the assigned therapeutic area.
• Foster a culture of continuous improvement and innovation within the local GCO team.
• Model Credo based culture within the local GCO team.

Requirements

• Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is required.
• Minimum of 5 years of clinical research experience in pharmaceutical industry, CRO or investigational site.
• At least 5 years of oncology experience, preferably in late development.
• Effective communication and leadership skills.
• Ability to foster team productivity and cohesiveness.
• Effective issue resolution and ability to generate and implement contingency plans.
• Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
• Ability to evaluate data generated from various reports and sources.
• Demonstrated skills in effective communication with various internal and external stakeholders.
• Visionary leader who can shape the organizational culture.
• Experience in mentoring/coaching (line management experience desirable).
• Proficient in decision-making and financial management.
• Flexible mindset and ability to work in a fast-changing environment.
• Operates under limited supervision.
• Proficient in English language.
• Computer literacy.
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• 401(k) retirement plan participation.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 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.