Associate Director, Benefit-Risk - J&J Toronto IT & Technical Jobs

The Associate Director, Benefit-Risk will report into the Head of the Benefit-Risk team within Global Epidemiology in Innovative Medicine and serve as a consultant for benefit-risk methodology and patient-focused benefit-risk assessment, collaborating with and supporting Johnson & Johnson colleagues in cross-functional teams across R&D, the Office of the Chief Medical Officer, and the Global Commercial Strategy Organization.

Principal Responsibilities:

Lead structured benefit-risk assessments and patient preference studies including:
Guiding clinical teams in benefit-risk assessment of products in development
Applying structured benefit-risk, patient preference and decision analysis methods throughout the development lifecycle
Contributing as an author to internal and regulatory documents on plans and results from these analyses
Serving as an internal subject matter expert on these topics
Keep 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. Standard tools expected to be used in this role include:
Benefit-risk frameworks
Value trees
Statistical analysis plans
Effects tables
Preference studies
Lead benefit-risk and preference studies for development strategy, dose selection, clinical trials, regulatory documents, health authority advisory committee meetings, safety decisions 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 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 and Global Medical Safety departments and collaborate with colleagues in cross-functional teams in performing these responsibilities.
QUALIFICATIONS
Education:

A minimum of a Master’s degree in Epidemiology, Biostatistics, Decision Sciences, Health Economics, Public Health or related scientific field is required. Advanced degree (PhD, MD) in Epidemiology, Biostatistics, Decision Sciences, Health Economics, Public Health or related scientific field is strongly preferred.
Required:

A Master’s degree with a minimum of 5 years of hands-on experience in applied statistical, epidemiologic or benefit-risk analysis research; a PhD degree with a minimum of 3 years of hands-on experience in applied statistical, epidemiologic or benefit-risk analysis research; or a MD degree with a minimum of 3 years of hands-on experience and training in applied statistical, epidemiologic or benefit-risk analysis research and a degree or certificate in Epidemiology, Biostatistics, Decision Sciences, Health Economics, Public Health or related scientific field.
Experience using structured benefit-risk frameworks (e.g., FDA benefit-risk framework, BRAT, PrOACT-URL).
Knowledge of current academic/regulatory/industry trends in benefit-risk and patient-focused drug development.
Experience with tabular and graphical displays of benefit-risk data.
Experience presenting technical topics to clinical/medical audiences.
Excellent communication (verbal and written) and interpersonal skills.
Strong problem-solving skills.
Strong self-management skills with a focus on timely completion of competing deliverables.
The ability to collaborate with all levels in a cross-functional team environment.
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