Senior Director, Orthopedics Epidemiology & Real World Data Science

The Johnson & Johnson MedTech Epidemiology and Real World Data Science team is recruiting for a Senior Director, Orthopedics Epidemiology & Real-World Data Science. The position is located in New Brunswick, NJ, or at other J&J orthopedics sites at West Chester PA, Raynham, MA, Cincinnati, OH, Palm Beach Garden, FL, Titusville, NJ, or Horsham, PA.

Working remotely is an option for qualified candidates. The position reports to the VP of MedTech Epidemiology & Real-World Data Sciences within the cross-sector Global Epidemiology Organization and the Office of the Chief Medical Officer.

Johnson & Johnson MedTech Companies have been working to benefit patients by improving surgery for over a century. This position is an exciting opportunity to lead the real-world evidence generation program for market access and adoption within the orthopedic Depuy Synthes business unit.

The Senior Director will work with the Health Economics and Market Access (HEMA), Medical Affairs and Clinical teams to develop the strategic plan for RWE for the Orthopedic business unit and then lead their team in implementing the evidence plan using large healthcare databases or other data sources. The Orthopedic team consists of 3 Epidemiology researchers and 4 programmer analysts. The Senior Director will sit on the MedTech Epidemiology Leadership Team and the J&J Orthopedics (DePuy Synthes) Market Access Leadership Team and will participate in senior leadership activities of the Global Epidemiology Organization.

The MedTech Epidemiology and Real World Data Science team is an industry leader in using real world evidence for medical devices and technologies. We are driven by J&J's Credo to benefit the patients we serve of all races, ethnicities, genders and sexual orientation, to care for our employees, to benefit the communities and environment we work in and to work for the success our shareholders.

Our goal is to apply RWE as a tool to efficiently address the needs of J&J's MedTech sector and to benefit patients. To do this, we focus in 5 areas: 1) evidence for market access and adoption globally, 2) evaluations of product safety, 3) evidence for regulatory approvals (pre- and post-approval), 4) advancing the use of AI/ML use for MedTech, and 5) evidence for business development due diligence and identification of unmet needs. Because the use of RWE for MedTech is at its early stage, we play an important role in shaping the global environment for evidence from real-world data for medical devices.

Our principle is that close cross-functional collaboration leads to the most rigorous and on-strategy real-world evidence. In 2023, the team conducted 108 protocol-driven RWE studies for the MedTech sector and published 35 medical journal articles to disseminate the evidence according to J&J's transparency policy to make all protocol-driven research public. We also presented at 24 podium or workshop symposium oral presentations and conducted 32 internal trainings on RWE for J&J staff. Also in 2023, we obtained 3 FDA label extension approvals using the RWE we generated covering 8 medical devices.

Key Responsibilities:

• You will lead the design, conduct, publication and presentation of real-world evidence studies using large healthcare databases for the orthopedic business unit (DePuy Synthes) for market access and adoption purposes. The goal is to assess the value of new technologies on patients' well-being, the healthcare system and the costs of care and prepare for value-based contracting.

• You will lead a team of 3 team members (a Director and 2 Associate Directors), 4 programmer analyst contractors and one medical writer contractor.

• You will actively partner with the Health Economic and Market Access (HEMA) team for evidence generation, as well as Medical Affairs, Scientific and Clinical Affairs, and R&D.

• You will lead the design and implementation a portfolio of RWE projects using healthcare database studies, including protocol development, statistical analysis, journal article publishing, and conference podium presentations.

• You will be a member of the J&J MedTech Epidemiology Leadership Team and the J&J Orthopedics (DePuy Synthes) Market Access Leadership Team

• The scope of work includes comparative studies of costs and patient outcomes, generating evidence for economic models, eg, to the quantify the frequency of adverse outcomes after device implementation and the costs of associated with adverse or favorable outcomes.