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Manager Clinical Operations, Oncology - 2406214022W

Description

Johnson & Johnson is currently seeking a Clinical Operations Manager, Oncology. This position can be located remotely within the United States.

Manager Clinical Operations is accountable for the 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. The Manager Clinical Operations supports US Solid Tumor TA Director in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.

This individual is responsible for line management of Local Trial Managers (LTM) and Clinical Trial Assistants (CTA) and/or other GCO staff, as required. Oversees's staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/Global Development (GD) overall.

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 https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

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 GCO management accordingly.

• 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 (internal and external to the organization).

• 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 to position the local and global GCO organization for success.

• Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.

• Accountable for ensuring 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.

• Review operational and quality metrics regularly and drive follow-up actions as appropriate.

• Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/GD overall.

• Foster a culture of continuous improvement and innovation within the local GCO team.

• Model Credo based culture within the local GCO team.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Qualifications

Qualifications

Education:

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

Experience and Skills:

Required:

• Minimum of 5 years of clinical research experience acquired 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 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 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.). Influential in improving the clinical research environment at a country level.

• Visionary leader who can shape the organizational culture to improve adoption of future state.

• 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 within a matrix environment.

• Perform activities in a timely and accurate manner.

Other:

• Up to 25% travel is required.

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

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.

Primary Location NA-US-New Jersey-Raritan

Other Locations NA-United States

Organization Janssen Research & Development, LLC (6084)

Relocation Eligible: No

Job Function Clinical Trial Project Management

Req ID: 2406214022W