Janssen Research & Development, LLC., a division of Johnson & Johnson’s Family of companies is recruiting for a Senior Director, Real-World Evidence – Oncology Data Science. Is this person you?
The primary location for this position is Spring House, PA. Consideration will be given to South San Francisco, CA; Cambridge, MA; Raritan, NJ; La Jolla, CA; and Beerse, Belgium.
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 purse the most promising science, wherever it might be found. Please visit http://www.janssenrnd.com/
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 Senior Director will direct and lead efforts to bring innovative uses of Real-World Evidence (RWE) to the Oncology Clinical Development organization. The Senior Director will have global leadership responsibilities for a wide range of activities, including capability and talent development, resource management and deployment, and supporting an organizational culture that promotes decision-making with data across all functions of Janssen Oncology. He/She will be a leader with vision within Janssen R&D in the field of pragmatic use of RWE for drug development processes. He/She will develop and implement elegant applications with RWE to tackle complex problems facing all drug development stages. This will require gaining alignment with project teams, leadership and external partners in developing novel scientific approaches to advance the business.
Specific challenges will include identifying novel applications for RWE in drug development processes, identifying, procuring and curating suitable data sets, and prioritizing analytic efforts to achieve these goals. Understanding and aligning with drug development team goals is essential. The role requires a broad knowledge of drug development, including clinical trials. Creativity to invent and customize will be necessary. You’ll be part of a dynamic, accomplished team that supports the development of novel medicines at Janssen Oncology R&D.
In this role, you will:
- Partner with cross-functional clinical development teams in crafting and reporting on RWE plans to support clinical/research objectives throughout the drug development lifecycle. Actively lead and communicate RWE plans for/with clinical development teams. This will include seeking and handling feedback with internal and external partners.
Coordinate with internal and external partners to execute high impact RWE studies. This includes identifying and procuring data sets for bespoke applications. Liaising with external partners
Work with clinical and research teams to develop data requirements to meet RWE objectives, including both regulatory-grade and observational research data sets
Work with clinical and Data Science teams and external partners to execute analytics on RWE studies.
- M.D. or Ph.D. degree + 10 years or Master’s degree with 15+ years of relevant experience, in Biomedicine, Pharmacology, Statistics, Bioinformatics, Computational Biology or a related discipline.
Strong working knowledge of drug development, with established expertise with multiple components of drug development, such as translational research, clinical studies, or regulatory interactions.
- Experience with the use or RWE in drug development. This should include developing requirements and plans for RWE-based studies.
Capacity to manage timelines and drive key deliverables in a matrix environment.
Established Leadership skills, including management of individuals and teams working towards common clinical/scientific goals
- Prior experience working and driving external partnerships, either corporate or academic
Experience with establishing clinical trial enrollment criteria, developing and interpreting clinical endpoints
- Ability to effectively communicate technical work to a wide audience.
Willingness for occasional domestic/international travel
- Proficiency with regulatory submissions and interaction.
Fluency in basic in data analytic/statistical techniques/applications
- Experience with novel, innovative ways to approach drug development is an asset.
Thriving on a diverse company culture and celebrating the uniqueness of our employees, we are committed to inclusion. We are proud to be an equal opportunity employer.
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.
Working with Johnson & Johnson can change everything. Including YOU.
United States-Pennsylvania-Spring House-
North America-United States-California-San Francisco, North America-United States-Massachusetts-Cambridge, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-California-La Jolla
Janssen Research & Development, LLC (6084)