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Associate Director Benefit-Risk

Leiden, Netherlands; Beerse, Belgium; Titusville, United States; Horsham, United States; Raritan, United States; Allschwil, Switzerland; High Wycombe, United Kingdom; Toronto, Canada

Description

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Benefit-Risk.  This position can be located in Titusville, NJ; Raritan, NJ; Horsham, PA; Toronto, Canada; High Wycombe, U.K.; Beerse, Belgium; Leiden, Netherlands; or Allschwil, Switzerland.  Remote work options within the United States may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.  Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.  We bring together the best minds and pursue the most promising science.  We are Janssen.  We collaborate with the world for the health of everyone in it.  Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.  Please visit http://www.janssenrnd.com for more information.

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.

Preferred:

  • Experience in quantitative benefit-risk assessment (e.g., multi-criteria decision analysis, SMAA).
  • Experience with patient preference studies (e.g., discrete choice experiments, best-worst scaling, threshold technique).
  • Experience with decision analysis (e.g., decision trees, strategy tables, sensitivity analyses).
  • Publication record or evidence of scholarship in benefit-risk assessment, patient preference studies or related topics.
  • Experience in Hematology and/or Oncology Therapeutic Areas.
  • 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., SAS, Stata, R, MATLAB, S-PLUS).
  • Experience leading projects with multi-stakeholder teams (e.g., clinical, statistics, regulatory) on technical projects.

Other:

  • This position will require up to 20% domestic and international travel (up to 10% for individuals located at one of the New Jersey or Pennsylvania sites).

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $166,000 to $267,145.

The anticipated base pay range for this position in all other U.S. locations is $135,000 to $232,300.

The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.  Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

* The compensation and benefits information set forth in this posting applies to candidates hired in the United States.  Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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