Associate Director, Epidemiology

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 pursue the most promising science, wherever it might be found.

We are currently hiring an Associate Director of Epidemiology within our Infectious Diseases & Vaccines TA to be located: primary location: Beerse, Belgium, Leiden, Netherlands, or Alschwil, Switzerland; secondary location: United States - New Jersey-Titusville; New Jersey-Raritan; Pennsylvania-Horsham, Pennsylvania-Spring House.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. 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 Primary Responsibilities Of The Associate Director Will Be:

The Associate Director will work largely independently, and may also function under the supervision of more senior members of the department, primarily providing support to the Janssen Vaccines area, with an initial focus on the Janssen COVID-19 vaccine.

• To support the design and conduct of the Janssen COVID-19 vaccine post-marketing safety and effectiveness studies/Regulatory Commitments, including ensuring evidence delivery coordinated with multiple external research partners and internal cross-functional teams
• To provide timely support to global medical safety including: periodic safety reporting of epidemiology sections to Regulatory Authorities (PBRER/PSUR), quantitative analyses, vaccine coverage assessment, and quantitative benefit-risk analysis
• To promote (re)use of standardized tools to support real world evidence generation in the framework of vaccine authorization and access per integrated plan across functions utilizing RWE (burden of disease, medical need, disease progression,…) as part of the Integrated Evidence Generation Plan
• To collaborate with internal stakeholders (e.g. global medical safety, global regulatory affairs, medical affairs, market access, data science, etc) and externally with industry (e.g. PhRMA/BIO, R&D COVID Vaccine consortium), public-private (e.g. IMI), professional (e.g. ISPE) and patient associations to advance data sources, methods, and best practice in producing fit-for-purpose RWE
• To provide epidemiological and/or statistical consulting and support to product teams, and disseminate technical information through technical reports, presentations, and publications in peer-reviewed literature as agreed by the team
• To identify research study needs, draft proposals and protocols, and contribute to epidemiology (RWE) strategy and study conduct across the clinical development program

Qualifications

• A 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 6 years of hands-on experience is required
• At least 5 years of Epidemiology research experience is required
• Must have an understanding and the ability to interpret quantitative methods
• Experience with writing protocols in general and particularly the statistical methods sections of study proposals and/or proposal requests is required
• Experience working with large administrative or medical records databases is required
• At least 5 years of pharmaceutical industry experience is preferred
• Experienced with non-randomized designs is strongly preferred.
• Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to infectious disease or vaccines is preferred
• Experience working with health authorities is preferred
• Phase III/IV experience is preferred
• Experience working in a global environment is preferred

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.

Primary Location
Belgium-Antwerp-Antwerp- Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, Switzerland-Basel-Country-Arlesheim
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
2105913347W