Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Medical Affairs Operations Global Program Leader, Investigator-Initiated and Collaborative Studies with location in EMEA (Belgium/Netherlands) or US (Raritan, Titusville, Springhouse).
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, and pulmonary hypertension. Please visit https://www.janssen.com/research-and-development for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Medical Affairs Operations Global Program Leader (MAO GPL), reporting to the Global Operations Head for Investigator-Initiated and Collaborative Studies is accountable for successful operational planning, setup and execution of a portfolio of Investigator-Initiated and Collaborative Studies within the assigned therapeutic areas (TAs). This includes adequate resource planning and allocation; meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements; as well as driving issue identification and resolution, contingency planning, and decision-making.
The MAO GPL for Investigator-Initiated and Collaborative studies acts as the single point of end-to-end accountability within GCDO-MAO for an assigned portfolio of Investigator-Initiated and Collaborative studies of the assigned TAs. For the assigned Investigator-Initiated and Collaborative studies, the GPL will manage relationships with global, regional and local Medical Affairs teams, R&D and other internal trial sponsors, as well as with other external suppliers and enterprise sectors, as applicable.
The MAO GPL will lead a team of GD Trial Leaders (GTLs), Trial Managers (TMs) and G-Clinical Trial Assistants (G-CTA). Along with line management responsibilities, the GPL is accountable for managing and developing staff within his/her scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering a diverse work force that works seamlessly in a highly matrixed environment.
- Single point of end-to-end accountability for the assigned portfolio of Investigator-Initiated and Collaborative studies .
- Drives the start-up of assigned portfolio of Investigator-Initiated and Collaborative studies .
- Align on project strategy with the Medical Affairs team, R&D, and other internal trial sponsors, as well as with other enterprise sectors, as applicable.
- Provide operational input in the design and implementation of the program including sourcing decision, and oversee the development and implementation of operational support for a portfolio of Investigator-Initiated and Collaborative studies, including sourcing approach.
- Discuss Investigator-Initiated and Collaborative study key operational questions with the GOH, as appropriate
- Ensure critical operational elements are available in a timely fashion to allow optimal project preparation where applicable.
- Drive the Request for Service (RFS) process; partnering with key functions in the preparation and assumptions that make up the RFS.
- Oversees the execution and close out of assigned portfolio/programs
- Ensures effective budget management for all projects. Partner with the Functional Planning (FP) group for project related milestones and adequate resources. Ensures accurate trial budget management and reconciliation of all assigned portfolios. Oversees Global Trial leaders (GTLs) and Trial Managers (TMs) in the overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Monitor resource availability and ensure operational consistency across all activities of the Investigator-Initiated and Collaborative Studies Management Teams.
- Promote optimal communication between the GTLs/TMs/G-CTAs and GD functions, internal trial sponsors, key internal partners and external service providers
- Ensure timely status updates on project deliverables are provided to the Medical Affairs Team, R&D and other internal trial sponsors and/or other enterprise sectors, as applicable.
- Identifies and proactively manages issues in a timely manner.
- Communicate regularly with the GOH on all issues and risks related to project resources, timelines and budget. Make recommendations for solutions and align with the GOH on the Action Plan.
- Work with relevant project stakeholders and Study Management Teams to implement solutions/Action Plan.
- Ensures that all project objectives are met according to all applicable regulations, legislations, guidelines and internal SOPs/policies.
- Manages and supports training and development needs of direct reports to meet the enterprise wide leadership standards for current and future employment opportunities while valuing a diverse work force.
- As applicable, acquires and sustains advanced knowledge of the appropriate Therapeutic Area, product and project setting.
- Establishes strong relationships with the GOH and other Global Program Leaders within GD across all regions and Therapeutic Areas.
Decision Making Responsibilities:
- Evaluates operational implications of clinical development plans and study design when appropriate.
- Provides recommendations to GOH on project execution strategies and People Management-related topics.
- Contributes to the design, development, and evaluation of the Clinical Operations processes and standards.
Internal contacts: GOHs, other GPLs, GTLs and G-CTAs, GCO Country Heads, Regional and Country Medical Affairs teams, Clinical Development Teams, GD functions, CMO, DPDS, Finance Department, Legal, Procurement, Regulatory, Quality Management & Training group; Study Management Teams, and other J&J enterprise sectors, as applicable.
External contacts: external service providers, clinical investigative sites and their research Qualifications
- A minimum of Bachelor’s Degree or equivalent is required. Advanced Degree in a scientific discipline and/or Master Degree is preferred.
- A minimum of 8 years of experience in clinical development within a pharmaceutical company and/or a CRO, with some level of Company-Sponsored, Investigator-Initiated, or Collaborative studies.experience is preferred.
- Expertise in the areas of drug development, clinical operations, strategic planning, and in-depth knowledge of Medical Affairs preferably in Company-Sponsored, Investigator-Initiated, or Collaborative studies.
- Sound clinical financial acumen; experience with managing budgets is required. CRO management experience is preferred.
- Effective leadership skills and proven ability to foster team productivity and cohesiveness. Excellent communication skills and the innate flexibility to work in a rapidly growing and highly matrixed organization.
- Full understanding of all logistical aspects when running Investigator-Initiated and Collaborative studies regionally and locally, and a good understanding of the therapeutic areas where J&J is involved.
- Experience in managing and mentoring clinical operations team members. Excellent people leadership skills in a matrix environment is required, people management experience is strongly preferred.
Following skills are required to be considered further:
- Trusted, inclusive, leader with demonstrated experience in managing/ mentoring global, cross functional matrix teams and a proven ability to foster team productivity and cohesiveness.
- Able to balance the customer needs and the business demands.
- Ability to provide strategic leadership, proven decision-making skills, strong negotiating and conflict resolution skills
Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-FranceOrganization
Janssen Pharmaceutica N.V. (7555)Job Function