Vice President Global Medical Affairs Op

Johnson & Johnson/Janssen is recruiting for a VP, Global Medical Affairs Operations, located at any Janssen R&D hub in the US (preferably NJ/PA area) or EU (Belgium, Switzerland, Ireland).

**Position Summary**:
This role is charged with leading a team in the spirit of Our Credo. This involves partnering with the Global, Regional and Local Medical Affairs Organizations across Janssen to provide strategic operational support (operational strategy, planning and execution) to deliver the Medical Affairs* portfolio of studies, as identified (not exclusively) in the Integrated Evidence Generation plans and programs. This will include Interventional and Non-interventional Trials/Studies, Traditional and Real-World Evidence, Company-sponsored studies, Established Products, externally sponsored studies (Investigator Initiated and Collaborative Studies), Managed Access (Compassionate Use) Programs, and a range of Post-Marketing Commitment-types of studies.

This team has a broad geographic footprint, with staff over 6 continents.
- Medical Affairs (among others, i.e., Established Products, Epidemiology as needed, specific R&D studies, Data Science as needed studies )

**Key Responsibilities**:

- Develop strong relationships within Janssen in R&D, Global Development and Medical Affairs, at Global and Regional levels, to ensure alignment of process and systems, sharing of best practice, etc.
- Strengthen the voice of the Medical Affairs organization within Global Development, advocating for this group’s needs
- Align strategic planning and develop capabilities to meet the needs of stakeholders
- Provide technical and operational leadership, which will include accountability for substantial budget and resource management.
- Accountable for all Trial Coordination activities for the entire global Medical Affairs portfolio of products.
- Drive the determination and ensure execution of an appropriate sourcing strategy for the Medical Affairs Operations group and find the appropriate balance between in
- and out-sourcing, in full coordination with the broader R&D Sourcing Strategy.
- Develop and implement strategies for appropriate operationalization of capabilities such as Investigator Initiated/Collaborative Studies, Real World Evidence and Pre-approval and Managed Access, and build the relevant expertise within the team.
- Responsible for attraction, engagement, and development of the team, to ensure the function has suitable leaders and skilled staff to meet the needs of the growing/changing function for the future.
- Contribute to the Vision and Strategy of helping to make J&J’s Global Medical Affairs Operations function the best-in-class in the industry.
- Define the vision, short and long-term strategic direction, and goals in conjunction with Business Partners.
- Build the MAO organization to deliver an increasing number of complex, multi-country trials.
- Improve/understand and position for adherence and influence the MAO trials according to Health Authority regulations.
- Create an optimal execution model for sponsored studies.
- Capture new trends in data collection and/or define direction for Real World Data; contribute to the overall Janssen environment of evolving RWE initiatives.
- Ensure customer focus, the sharing of best practices, and promoting opportunities across the global team.
- Lead and represent in the CRO Governance models.
- Ensure the regions execute on timely and realistic planning of studies and country participation.
- Plan and ensure timely resources are on board and deliver studies of the highest quality, within budget and agreed timeframes.
- Drive a culture of innovation and continuous improvement to increase customer satisfaction across the global organization.

**Qualifications**

**Qualifications**:
**Education**:

- B.S. in a science discipline, coupled with an MBA or similar level qualification is preferred. All additional degrees and experience will be considered advantageous.

**Experience and Skills**:
Additional experiences that contribute to the successful execution of this role:

- Experience having led or operated as the number two in a large multi-site and global Clinical Development Operations organization.
- Solid Phase IV Clinical Operations experience.
- Solid business acumen; demonstrated success working with a Commercial organization.
- Experience leading a sizable team; ability to mentor, guide and ensure performance parameters are met.
- Experience operating in a complex matrix environment, managing resources, budgets, and multiple programs, with demanding timelines.
- High comfort with a highly complex environment of stakeholders
- Experience in strategic planning, specifically in clinical trial operations.
- Strong vision of excellence in Medical Affairs Operations.

**Principal Relationships**:
**Global Regional and Local Medical Affairs organizations**

All Departments within Global Development with special connectivity with GD Senior Leadership Team

**Globa