At J&J, 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 collaborate with the world for the health of everyone in it. The Lung Cancer Initiative (LCI), which is a cross-sector initiative, is charged by the Executive Committee of J&J with meaningfully altering the course of lung cancer and improving survival by preventing, intercepting, and curing lung cancer. Similarly, the World Without Disease Accelerator (WWDA) is a cross sector R&D organization working on disease interception in other areas such as Type 1 diabetes, atopic dermatitis, and celiac disease.
The Johnson & Johnson LCI is recruiting for an Associate Director, Clinical Operations Lead. The incumbent will support the execution, implementation, tracking, and communication of cross-functional, cross-sector, operational strategies for LCI studies (inclusive of early development and late development). The incumbent would be responsible for supporting the development of tracking and management of status of trial activities which could include working to identify technology solutions leveraging CTMS data, etc.
The LCI Clinical Operations Lead will be expected to organize, manage, and support the continued development of a site network to deliver local delivery studies. They are also expected to ensure optimal partnership and interactions with internal stakeholders and external sites.
The LCI Clinical Operations Lead will support the administration of the Clinical Operations Strategy and Execution Committee (COSEC), a body of cross-sector and critical stakeholders, including PMO, SEO, Business Operations, Clinical, & Medical Safety.
The lead will also support continued optimization of processes and systems to best enable the Clinical Operations execution for the LCI.
“Remote work options may be considered on a case-by-case basis and if approved by the Company.”
The anticipated base pay range for this position is $112,000 to $168,000
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Specific Responsibilities (include, but are not limited to):
- Accountable for the management and tracking of cross operational deliverables within LCI portfolio for insourced, outsourced, and hybrid programs. Coordinates across functions and sectors, to ensure status, risks, and needs are appropriately communicated and addressed.
- Assist in the determination of (new) capabilities required (including new vendors to be identified).
- Ensures common operational issues/challenges are identified and addressed through operational risk mitigation.
- Supports the administration of the COSEC and its continued optimization, including scheduling, managing content prep, and dissemination of summary notes.
- Leads or supports LCI Clinical Operations projects. Establishes strong interaction with the cross-sector partners.
- Monitor set specific and measurable performance objectives, standards, and accountabilities for each site of excellence/alliances.
- Support the development of strategies strategy to proactively identify and manage risks and opportunities and resolve issues that arise with clinical sites, including documentation and managing communication
- Responsible for managing the site network and establishing a mechanism to track progress, deliverables, and communication. Includes assisting in developing, in coordination with and across functions, on standard metrics, and measurements for the network.
- Establish and manage a repository of site communication, process agreements, previous sites of excellence/alliances performance, including cost, enrolment, and data quality
- Conduct business in line with Health Care Compliance (HCC), company policies and procedures, including applicable SOPs, always having the ethical aspect in mind.
- Contribute to the development and improvement of LCI/WWDA clinical operations procedures and processes and templates in the scope of the company’s efforts towards continuous quality improvement.
- Develop strong relationships to optimize the collaboration within and beyond PDO, incorporating externally with our vendor partners, to align with key business priorities and annual goals and objectives
A Bachelors in biological sciences or related discipline is required.
- Minimum of 8 years of clinical trial experience in the pharmaceutical or medical device industry or CRO is required
- Must have experience managing all aspects of execution of a clinical trial is required
- Requires clinical research operational knowledge, project planning/management, communication, and presentation skills is required
- Analytical and strong financial management skills are required.
- Experience managing or leading global or regional teams in a virtual environment is required.
- Ability to think strategically, while staying focused on monitoring the progress of action items and bringing them to conclusion within appropriate time frames is required
Location: United States – New Brunswick, Chesterbrook, Horsham, Remote
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.]