Manager Epidemiology

Johnson & Johnson Innovative Medicine•San Diego, CA

1d•$117,000 - $201,250•Onsite

About The Position

The Manager, Oncology Epidemiology role is accountable for working independently and supporting work across the Oncology Epidemiology team under the supervision of more senior members of the department. This role involves assisting with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology study conduct and analyses across the therapeutic area portfolio, and supporting interpretation and communicating evidence to internal and external stakeholders. The position also requires conducting literature reviews, incorporating AI tools, assisting with study design, and identifying/evaluating data resources. Additionally, the role involves conducting feasibility assessments, executing analyses, providing epidemiological and statistical consulting, and disseminating technical information. A key aspect is researching the natural history of diseases, performing statistical risk assessments, using historical data to contextualize safety issues, supporting benefit-risk assessments, and assisting with post-authorization safety activities. The role may also involve participation in cross-departmental committees and staying updated on regulatory requirements from agencies like the FDA regarding Post Approval Authorization Studies, Risk Management plans, and the use of Real-World Evidence (RWE) for Regulatory Decision Making.

Requirements

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 2 years of hands-on experience is required.
At least 2 years of Epidemiology research experience is required.
Must have an understanding and the ability to interpret quantitative methods.

Nice To Haves

Experience with writing observational study protocols, proposals, and/or proposal requests, particularly the methods sections, is preferred.
Experience working with large administrative or medical records databases is preferred.
Experience working with Artificial Intelligence based tools
A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is preferred.
Applied pharmacoepidemiology research is preferred.
Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to the disease specific 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.

Responsibilities

Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology study conduct and analyses across the therapeutic area portfolio, and supporting interpretation and communicating evidence to internal and external stakeholders.
Conduct literature reviews and synthesis while incorporating AI and other tools where appropriate; provide assistance to senior epidemiologists and clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs.
Assist with conducting fit for purpose database and study feasibility assessments and executing analyses across the product cycle, while working closely with colleagues in the Observational Health Data / Oncology Specialty Analytics group.
Provide epidemiological and/or statistical consulting, education and support to product teams, and assist with disseminating technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team.
Assist research in natural history of diseases, both within and outside of existing electronic databases, 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; assist in design and conduct of post-authorization safety activities, including rapid analytics for signal strengthening and formal required/committed evaluation studies, as part of Pharmacovigilance and Risk Management Plans.
May 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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year