Titusville, New Jersey; Raritan, New Jersey; Horsham, Pennsylvania; Spring House, Pennsylvania
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Benefit Risk / Epidemiology located in Titusville, NJ, Raritan, NJ, Horsham, PA or Spring House, PA.
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.
The Associate Director will serve as an internal consultant for benefit-risk methodology and patient-focused benefit-risk assessment, collaborating with and supporting colleagues in Clinical, Safety, Epidemiology and other departments. They will be expected to keep up to date with regulatory agencies and other critical organizations regarding policies and methodologies for benefit-risk assessment, patient preference studies and the use of electronic, patient-level databases and other emerging epidemiologic research tools and standards.
The Benefit-Risk / Epidemiology Associate Director’s primary responsibilities will be to lead structured benefit-risk assessments but may include epidemiology work as needed.
The overall responsibilities include guiding clinical teams in medication/device benefit-risk assessment and applying structured benefit-risk and decision analysis methods throughout the development lifecycle. Standard tools used in this role include benefit-risk frameworks, value trees, effects tables and patient preference studies (Strong applicants with limited experience in some of these methods can be trained in the role.) Applications include leading benefit-risk and preference studies for development strategy, clinical trials, benefit-risk sections of regulatory documents, health authority advisory committee meetings and safety decisions. The Associate Director is also expected to assist with internal benefit-risk process development, participate in external benefit-risk methodology and policy activities, author publications on their work and present at external meetings.
Epidemiology responsibilities are secondary in this role but may change over time depending on the applicant’s interest and skills. They may include: exploring external electronic, patient-level databases to evaluate disease natural history, clinical and surrogate endpoints, and medication and device safety/benefit-risk questions; literature review and synthesis, assistance of clinical teams with study design, contributing to the planning and conduct of meta-analyses of safety data from ongoing trials and other sources, and participation in internal or external task forces on issues raised by product teams/regulatory agencies. Work may also include using historical clinical trial data to develop an understanding of potential safety issues for new devices, medications, and indications.
The Associate Director will work closely with more senior members of the Epidemiology department and collaborate with colleagues in other department in performing these responsibilities.
A PhD in Epidemiology, Biostatistics, Decision Sciences, Health Economics, Public Health or closely related field; or an MD coupled with training and a degree in one of these fields
Four or more years hands-on experience in applied statistical, epidemiologic or benefit-risk analysis
Demonstrated excellent interpersonal, verbal and written communication skills, especially experience in presenting technical topics to clinical/medical audiences
Self-management skills with a focus on timely completion of competing deliverables, demonstrated problem solving ability and the ability to successfully collaborate with teams
Experience with structured benefit-risk frameworks and current trends in benefit-risk and patient-focused drug development
Experience with tabular and graphical displays of benefits and harms
Experience in quantitative benefit-risk assessment
Experience with writing statistical methods sections of study proposals or statistical analysis plans
Experience working with health authorities
Publication record or evidence of scholarship in benefit-risk assessment, patient preference studies or related topics
Experience with analytical or statistical tools such as SAS, Stata, R, MATLAB, or S-PLUS
Travel will be up to 20% for a candidate located in North America or up to 10% if the candidate is located in the Titusville, NJ, Raritan, NJ, Horsham, PA or Spring House, PA locations.
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