Senior Director Real World Evidence and Market Access Analytics (RWE & MAA)
- Bridgewater, NJ
We are looking for a Senior Director Real World Evidence and Market Access Analytics (RWE & MAA)responsible for the development of RWE & MAA strategies to to meet the needs of increasingly evidence-driven and cost-conscious HTA agencies around the world.
The Senior Director leads a team that provides evidence that both informs and complements the evidence generated across Janssen's R&D clinical development programs.
This role is responsible for recruiting, resource planning, and talent management.
It is responsible for the development of all employees within the team including technical and leadership development and training to meet current and future business needs.
Leads and ensure scientific rigour for data generation projects including: protocol development, planning, management and publication. Job content includes:
- Foundational evidence (treatment patterns, disease progression, key healthcare resource use [e.g. hospitalization]), along with identification of key sub-groups and responders.
- Analyses of key endpoints including surrogate endpoint validation
- Comparative effectiveness research using (network) meta analyses and analyses of individual-level patient data from trials and real-world sources
Effectively collaborates with colleagues across different functions within Janssen including:
- Works closely with Market Access, Data Sciences and other colleagues to understand key global and regional research needs and opportunities. Contributes to products' Integrated Evidence Generation Plans (IEGPs) and Data Sciences plans (foundational evidence) for Disease Area Strongholds.
- Aligns and works closely with other quantitative functions (Quantitative Sciences, Data Science, Epidemiology, and regional teams) to drive and implement innovative statistical approaches and increase capabilities (RWE Leadership Team).
- Works closely with the economic modeling team to create synergies with the design and population of economic models
Works effectively with external partners to identify relevant data, conduct relevant analyses and build relevant capabilities. For example through the design and management of research workstreams within our existing research partnership with the Karolinska Institute in Sweden. Overall, ensures that analyses by team are rigorous and suitable for communication to HTA agencies, the scientific community and other relevant agencies.
- Knowledge of secondary data sources (surveys, claims data, electronic medical records, registries etc).
- Basic knowledge of SAS programming and other significant statistical software (such as R)
- Ability to think and act strategically.
- Able to manage work into clear and realizable project plans with appropriate resources and timelines.
- Strong verbal and written communication skills tailored to specialist vs. cross-functional audiences for both internal as well as external communications
COMPLIANCE AND RISK MANAGEMENT
- Complies with designated SOP's and mandatory training for the role including: pharmacovigilence, Health Care Compliance and data privacy requirements.
- A postgraduate degree (e.g., MSc, PhD) in a relevant discipline (Biostatistics, Bioinformatics, Data science, Epidemiology, Health Economics) and 12+ years of experience is required.
- Knowledge of Real World Evidence and experience in evidence generation including dissemination.
- Track record of developing junior staff with both technical and leadership skills is required (5+ years).
- Knowledge and applied experience with data sciences tools (machine learning, natural language processing, predictive modeling, etc.) is an advantage.
- Experience of working in a virtual team environment and/or managing direct reports in multiple locations is preferred.
- Experience with working with R&D, Biostatistics, Data Sciences, Regulatory Affairs and Compound Development Teams for early as well as late stage assets in drug development is an advantage.
- Knowledge and applied experience (clinical trials, RWE) in at least one of the following therapeutic areas: Oncology, Infectious Diseases & Vaccines, Pulmonary diseases, Neuroscience, Immunology, Cardiovascular & Metabolism and/or Ophthalmology is preferred.
- Strong understanding of regulatory authority processes and guidances and drug development is required
- Understanding the reimbursement requirements and HTA review process for key international markets is an advantage.
- Proven ability to work effectively in a complex, decentralized and diverse organization, able to successfully influence in a matrix environment.
This role is based in either Raritan (NJ) or Beerse (Belgium). Up to 20% travel may be needed.
North America-United States-New Jersey-Raritan
Janssen Pharmaceutica N.V. (7555)
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