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R&D Operations

Functional Manager, Global Clinical Operations - U.S. Oncology (1 of 3)

  • 타이틀 Functional Manager, Global Clinical Operations - U.S. Oncology (1 of 3)
  • 부서 R&D Operations
  • 하위 기능 Clinical Trial Project Management
  • 범주 Manager, Clinical Trial Project Management (P7)
  • 위치 Raritan, New Jersey, United States; United States
  • 게시
  • [Close Date]
  • 참조 2406165367W
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공유

This job posting is anticipated to close on 4 13 2024. The Company may however extend this time-period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.

묘사

Janssen Research & Development LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a Functional Manager, Global Clinical Operations - U.S. Oncology.  This position can be located remotely within the United States.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information.

The Functional Manager, Global Clinical Operations (GCO) - U.S. Oncology will be 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.  This individual will support the Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency.

Principal 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 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 on priority shifts.
  • Review and approve expenses in compliance with the company policies.
  • Demonstrate leadership behaviors in alignment with Johnson & Johnson 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 long term strategy in alignment with GCO, Global Development (GD) 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 International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), relevant SOPs and other procedural documents.
  • Be accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
  • Contribute to Corrective and Preventative Actions (CAPAs) 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.
  • Be 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 GCO team.

자격

  • A minimum of a Bachelor's degree is required, preferably in a Life Science (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • A minimum of 5 years of clinical research experience within the pharmaceutical industry, Contract Research Organization (CRO) and/or investigational site is required.
  • Line management experience (medium to large size team of direct reports) is preferred.
  • Experience coaching and mentoring clinical operations team members is required.
  • Experience in the Oncology (Solid Tumor and/or Hematology) Therapeutic Area is preferred.
  • Experience managing and executing clinical trials is required.
  • Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
  • Financial management skills (e.g., budgeting, forecasting, risk analysis, etc.) preferred.
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
  • Proficiency with Clinical Trial Management Systems (CTMS), RAVE and Veeva Vault systems preferred.
  • Must have excellent communication, presentation and leadership skills, with the proven ability to foster team productivity and cohesiveness.
  • Must be skilled in leading, hiring, training, developing, and evaluating people.
  • Must have strong decision-making and issue resolution skills with the ability to generate and implement contingency plans for both productivity and quality issues when required.
  • Must have flexibility to work in a fast-changing environment and operate under limited supervision.
  • The ability to synthesize and evaluate data generated from various reports and sources is required.
  • The ability to effectively communicate with various internal and external stakeholders (e.g., investigational sites, ethics committees, health authorities, etc.) is required.
  • The ability to collaborate with all levels of management and handle multiple priorities within a matrix environment is required.
  • This position will require up to 25% travel, primarily for meetings and conferences.


The anticipated base pay range for this position in the San Francisco Bay Area, CA is $139,000 to $224,825.

The anticipated base pay range for this position in all other U.S. locations is $113,000 to $195,500. 

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
  • 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

This job posting is anticipated to close on February 15, 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.

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.