Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Biomarker Operations, located in La Jolla, CA (San Diego area).
At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Janssen Research and Development Biomarkers & Imaging team (“the team”) conducts molecular imaging research for all therapeutic areas as well as fluid and imaging biomarker work specific to Neuroscience. The team interfaces with many internal and external stakeholders and collaborators, demanding excellence in project coordination and timely execution. We are looking for a leader to manage a complex portfolio of pre-clinical and clinical projects.
The Manager of Biomarker Operations is responsible for all operational aspects of the team’s work, with a focus on the prioritization, planning, resource allocation, contracting, budget management and project execution.
The Manager of Biomarker Operations will join the Biomarker & Imaging leadership team and will partner with functional leaders from other areas to set project operational priorities and to implement them. S/he will manage two direct reports, responsible for biological sample and data management.
Responsibilities include, and are not limited to:
- Accountable for robust operational management supporting a portfolio of high value assets, with stakeholders across all therapeutic areas as well as internal and external collaborators.
- Manage the short, medium and long-term project planning to support and progress the team’s portfolio with focus on strategic needs.
- Provide clear, credible information about project status, critical path, and resource constraints to drive informed decision making at all levels of the organization.
- Manage contracting and compliance with J&J’s Credo and other policies; facilitate the required Business Process Risk Assessment (BPRA) as needed for any new suppliers and ensure that contract milestones are met and close out occurs in alignment with Procurement and Finance requirements.
- Partner with Legal regarding intellectual property, data privacy, material transfers, publications as related for each contract managed related to biomarker work.
- Be accountable for all Biomarker External Supplier Oversight Plans and participate as needed in BRQC mock inspections and Health Authority inspections.
- Ensure alignment with NS and JRD strategic sourcing decisions; manage all biomarker suppliers aligned with quality & compliance SOPS, with rigorous fiduciary and HCC accountability.
- Collaborate with enterprise partners to ensure alignment and enable seamless execution to meet the needs of internal and external stakeholders.
- Ensure critical stakeholders are aligned for biomarker contracts, including NS TA CDTLs, Global Project Leaders in GCDO, Procurement, Finance, Health Care Compliance, Legal and BRQC.
- Discover and apply organizational and process efficiencies and project learnings to drive continuous improvement.
- Maintain awareness and understanding of the team’s contributions to the drug development pipeline and ensure internal alignment with the needs of downstream partners.
- Identify opportunities to accelerate critical elements of the imaging and biomarker research process and collaborate with departmental stakeholders to develop and implement workable solution.
- Attend and participate in the neuroscience R&D operations group meetings.
- A Masters Degree or higher is required
- At least 4 years of experience managing Research and Development projects with progressive responsibility is required
- Demonstrated strategic awareness of organizational needs related to project planning and execution is required
- The ability to develop and implement solutions that improve organizational capability with measurable results is required.
- Team/project leadership experience and a proven track record are required
- Ability to interface effectively and positively with all levels of colleagues and external stakeholders is required.
- Energy and enthusiasm to inspire and mobilize people and teams are required.
- Experience working in a matrixed/cross functional environment is required.
- This position is located in La Jolla, CA, and may require approximately 15% travel (international and domestic).
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.
United States-California-San Diego-
North America-United States-California-La Jolla
Janssen Research & Development, LLC (6084)