Janssen Research & Development LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Global Clinical Operations (Functional Manager) - 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, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
The Manager, Global Clinical Operations (GCO) will be responsible for the direct functional management of a group of Local Trials Managers (LTMs), and Site Managers (SMs) in the Oncology Therapeutic Areas (TA) within GCO U.S. at Janssen.
This individual will be responsible for the recruitment, hiring, training and development of direct reports. Oversee project assignment, workload distribution and problem resolution with direct reports and, as needed, team management and other functions. Identify, train and provide oversight of consultants.
- Performance and development in accordance with Performance Management guidelines, including coaching, mentoring and routine feedback.
- Evaluate and project resource needs on an on-going basis.
- Ensure the implementation of clinical studies through efficient allocation of LTMs, SMs and Administrative Associates.
- Ensure close working relationship between other GCO US groups and internal/external business partners.
- Participate in/lead business-related task forces to improve processes.
- Have knowledge of GCO Standard Operating Procedures (SOPs) and fulfill the responsibilities per those SOPs.
- Ensure adequate, timely and compliant monitoring and management of clinical studies conducted in their TA.
- Ensure that team meets project deliverables according to timelines, within budget, and with quality.
- Ensure studies are in a constant state of inspection readiness.
- Communicate with staff on program changes, policy changes, and priority shifts on a regular basis.
- Be aware of issues affecting staff's workload and efficiency.
- Inform supervisor and fellow managers of potential problem situations and work closely on problem resolution.
- Ensure staff fulfills roles and responsibilities appropriately and in a timely manner.
- Review and approve expenses and ensure expense reports are being submitted on a timely basis and are in compliance with the company's policies.
- Participate in Management Staff meetings. Conduct staff meetings.
- A minimum of a Bachelor's degree is required.
- A minimum of 5 years of experience in Clinical Research within the Pharmaceutical, Contract Research Organization (CRO) and/or Biotech industry is required.
- Experience in the Oncology Therapeutic Area is required.
- Knowledge of CAR-T (Cell and Gene Therapy) is preferred.
- Experience managing and executing clinical trials is preferred.
- Experience with the direct management of employees is preferred.
- Demonstrated experience coaching and mentoring clinical operations team members is preferred.
- Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Must have excellent oral and written communication skills, along with strong presentation skills.
- Must have flexibility to work in a rapidly growing organization.
- The ability to collaborate with all levels of management in a matrix environment is required.
- This position will require up to 25% travel, primarily for meetings and accompanied site visits.
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
United States-New Jersey-Raritan-920 US Highway 202Organization
Janssen Research & Development, LLC (6084)Job Function