Apply on Employer Site

Johnson & Johnson Innovative Medicine · 21 hours ago

Associate Director, Benefit Risk/Patient Preference

Titusville, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

$137K/yr - $236K/yr

5+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to developing smarter and less invasive treatments. The Associate Director, Benefit-Risk / Patient Preference will lead benefit-risk assessments and patient preference studies, collaborating with cross-functional teams to support product development and regulatory submissions.

Pharmaceuticals

Responsibilities

Leading structured benefit-risk assessments and patient preference studies including:

Guiding clinical teams in benefit-risk assessment of products in development

Leading preference studies to support products in development, including designing preference studies for internal advisory boards

Applying structured patient preference, benefit-risk and decision analysis methods throughout the development lifecycle

Contributing as an author to internal and regulatory documents (e.g. statistical analysis plans, submission documents)

Serving as an internal subject matter expert on these topics

Keeping up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies and patient-focused drug development

Lead benefit-risk and preference studies for development strategy, dose selection, clinical trials, regulatory documents, health authority advisory committee meetings, safety decisions, treatment access and providing guidance on use of real-world evidence in benefit-risk assessment

Assist with internal benefit-risk process development and training, developing novel means to communicate and display preference and benefit-risk information, participating in external benefit-risk methodology and policy activities, authoring publications on their research and presenting at internal/external meetings

Work closely with members of the Global Epidemiology, Clinical and Global Medical Safety departments and collaborate with colleagues in cross-functional teams in performing these responsibilities

Qualification

Benefit-risk assessmentPatient preference studiesStatistical analysisEpidemiologyDecision analysisCross-functional collaborationSelf-management skillsTechnical credibilityCommunicationProblem-solving skills

Required

Master's degree in Decision Sciences, Health Economics, Epidemiology, Biostatistics, Public Health, or a related scientific discipline required; PhD or MD strongly preferred. MD applicants must also have a degree or certificate in one of these disciplines

A minimum of 5 years (3 year for PhD or MD) of hands-on experience in patient preference, benefit-risk, applied statistical or epidemiologic research

Knowledge of current academic/regulatory/industry trends in structured benefit-risk, preference studies and patient-focused drug development

Experience using structured benefit-risk frameworks (e.g., FDA benefit-risk framework, BRAT, PrOACT-URL) and/or experience with patient preference studies (e.g., discrete choice experiments, best-worst scaling, threshold technique)

Experience leading projects with multi-stakeholder teams (e.g., clinical, statistics, regulatory) on technical projects

Experience presenting technical topics to clinical/medical audiences

Excellent communication (verbal and written) and interpersonal skills

The ability to collaborate with all levels in a cross-functional team environment

Strong problem-solving skills

Strong self-management skills with a focus on timely completion of competing deliverables

Preferred

Experience with tabular and graphical displays of benefit-risk data

Experience in quantitative benefit-risk assessment (e.g., multi-criteria decision analysis, SMAA)

Experience with decision analysis (e.g., decision trees, strategy tables, sensitivity analyses)

Basic understanding of epidemiology methods

Experience with writing statistical methods sections of study proposals or statistical analysis plans

Experience working with Health Authorities

Experience working in a regulated biomedical/life science product development environment

Experience with analytical or statistical tools (e.g., R, SAS, Stata, MATLAB)

Publication record or evidence of scholarship in patient preference studies, benefit-risk assessment or related topics

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and 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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year