Functional Manager - Early Development and Clinical Pharmacology (Oncology)
J&J Family of Companies
322 N State St
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Janssen Research & Development LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a Functional Manager - Early Development and Clinical Pharmacology (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 for more information.
The Functional Manager - Early Development and Clinical Pharmacology (ED&CP) Functional will be accountable for strategic and operational management and successful country execution of early development and clinical pharmacology (Phase 0-IIa) trials across multiple therapeutic areas, 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 Functional Manager will also be accountable for shaping and managing local organizational ED&CP structure to ensure its optimal efficiency and demonstrates an effective issue management. This individual will be responsible for line management of Trial Managers (TMs), Site Managers (SMs), Clinical Trial Assistants (CTAs) and/or other Global Clinical Operations (GCO) staff as required. Oversee staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensure alignment of local goals with organizational objectives. Drive innovative solutions and process improvements for ED&CP, GCO and Global Clinical Development Operations (GCDO) overall.
+ 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 Global Head ED&CP/U.S. Head ED&CP accordingly.
+ Support the flexible resourcing model and collaborate with Flex Resource managers to hire 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, as required.
+ Support direct reports in issue resolution and communication with different stakeholders like Ethics Committees, Health Authorities, Investigational Sites and study management team.
+ 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.
+ Define and execute long term strategy in alignment with GCDO, ED&CP organization and Janssen R&D strategies to position the local and global ED&CP organization for success.
+ Accountable for attracting, planning, execution and monitoring of ED&CP clinical trials (from feasibility to close-out) and ensuring inspection-readiness for assigned portfolio and/or other area of responsibility as required.
+ Ensure 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 of (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 ED&CP organization, local GCO department, local R&D Head and Local Operating Company and other key internal and external stakeholders.
+ Develop country ED&CP capabilities and collaborates with GCDO Program Leader (GPL) and GCDO Trial Leader (GTL) for an effective study placement within the multiple Therapeutic Areas (TAs) and/or other area of responsibility, as required.
+ Accountable for robust feasibility process and oversight of sites selection to deliver on ED&CP country commitments and strategic goals.
+ Lead regular metrics review and drive necessary follow-up actions.
+ Ensure adequate quality oversight and inspection readiness within the different TAs and/or other area of responsibility, as required.
+ Oversight of local ED&CP budget and accurate financial reporting in compliance with financial processes.
+ Collaborate with local R&D Head and Late Development Functional Manager to implement specific local processes/regulatory requirements applicable for both Late Development and ED&CP teams.
+ Contribute to development, evaluation and implementation of new processes and systems to improve ED&CP studies management.
+ Foster a culture of continuous improvement and innovation within the local ED&CP team.
+ Model Credo based culture within the local ED&CP team.
+ A minimum of an Associate's degree or completion of a Nursing Program (RN) is required. A minimum of a Bachelor's degree in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is preferred.
+ A minimum of 5 years of Clinical Research experience within the Pharmaceutical, Contract Research Organization (CRO) and/or Biotech industries is required.
+ Prior clinical trial experience in Early Development and Clinical Pharmacology is preferred.
+ Experience in the Oncology Therapeutic Area is required.
+ Experience managing and executing clinical trials is preferred.
+ Experience with the direct management of employees is preferred.
+ Experience mentoring/coaching and providing training to others is preferred.
+ Strong knowledge of the drug development process, clinical research operations and regulatory requirements, including Good Clinical Practices (GCPs), Health Care Compliance (HCC) and FDA Code of Federal Regulations, is required.
+ Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
+ Must have excellent communication, interpersonal and presentation skills.
+ Must have strong leadership and decision-making skills.
+ Must have flexibility to work at a fast pace in a fast-changing environment.
+ The ability to synthesize and evaluate data generated from various reports and sources is required.
+ The ability to collaborate with all levels of management in a matrix environment and various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.) is required.
+ This position will require up to 25% travel, primarily domestic for meetings and accompanied site visits and occasionally international for meetings.
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.