We are currently recruiting for Associate Director, Oncology Epidemiology based in Switzerland.

The Associate Director, Oncology Epidemiology role is accountable for working independently, and in this role will also function under the supervision of more senior members of the department. The Associate Director, Oncology Epidemiology is responsible for oversight of various projects and initiatives in areas of epidemiology and real-world evidence research. This includes collaboration and stakeholder engagement with relevant clinical and product related and other RWE related teams, leading research projects, drafting protocols and statistical analysis plans, overseeing the analysis of real-world data (including, but not limited to, insurance claims data, hospital billing data, EMRs, curated oncology datasets, registries) and the dissemination of scientific information through technical reports, presentations, and publications in peer-reviewed literature.

Primary responsibilities:

• Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology / real-world evidence (RWE) strategy and study conduct across the therapeutic area portfolio.

• Work closely in collaboration with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, conducting analyses, and interpreting and communicating evidence to internal and external stakeholders.

• May conduct fit for purpose database and study feasibility assessments and execute analyses across the product cycle.

• Conduct literature reviews and synthesis; provide assistance to clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs.

• Provide epidemiological and/or statistical consulting, education and support to product teams, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team.

• Assist or work independently within and outside of existing electronic databases to:

• Assess feasibility of fit-for-purpose RWD; Research natural history of diseases to understand background event rates in the indicated population expected with standard of care

• Perform statistical risk assessments; use historical clinical trial data and other data sources to contextualize potential safety issues for new medications; support benefit-risk assessments throughout the product lifecycle; design and conduct post-authorization safety activities, including rapid analytics for signal strengthening and formal required/committed evaluation studies, as part of Pharmacovigilance and Risk Management Plans.

• Participate in various multi-disciplinary matrix teams to address issues raised by product teams/regulatory agencies where real-world data (RWD)/RWE can inform decisions.

• Work in cross departmental/sector committees, and or other efforts supporting J&J Innovative Medicine.

• Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Management plans and the development of formal guidance for use of RWE for Regulatory Decision Making.

Qualifications:

• PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 4 years of hands-on experience is required.

• At least 3 years of Epidemiology research experience is required.

• Understanding and the ability to apply and interpret quantitative methods is required.

• Experience with writing observational study protocols, proposals, and/or proposal requests, particularly the methods sections, is required.

• Experience working with large administrative or medical records databases is preferred.

• A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required.

• Applied pharmacoepidemiology research is preferred.

• Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to Oncology therapeutic area is preferred.

• Experience working with health authorities is preferred.

• Phase III/IV medicine development experience is preferred.

• Experience working in a global environment is preferred.