Associate Director, Patient Reported Outcomes - (Job Number: 0808527)

Associate Director, Patient Reported Outcomes - (Job Number: 0808527) DescriptionCentocor R&&D, Inc., a member of Johnson && Johnson's Family of Companies, is recruiting for an Associate Director, Patient Reported Outcomes, located in Chesterbrook, PA. Centocor R&&D, Inc. develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Job Responsibilities:The Associate Director, PRO works closely with the Patient-Reported Outcomes (PRO) Center of Excellence (COE) core team and PRO Directors (Leaders) to facilitate PRO-related activities in support of studies conducted for assigned products in development in the R&&D organization. The Associate Director, PRO serves as a PRO COE resource for the clinical teams in drug development. In this role, the Associate Director, PRO assists in evaluating existing PRO instruments. Serves as the project manager when creating new or modifying existing instruments. The Associate Director, PRO provides background information on competitor drug PRO research, conducts PRO literature searches, works with the clinical team to best incorporate PRO instruments into clinical studies, and generally represents the PRO team in clinical trial working groups/project management teams. Partner with PRO Leader to provide the clinical teams with the information necessary for the appropriate incorporation of PRO measures in clinical studies. Provide information and guidance to PRO Leaders in choosing appropriate PRO instruments for clinical studies. Partner with Project Management function in R&&D to determine time and events for all projects included in the overall PRO program for a product in clinical development. Responsible for oversight on all PRO projects (budget and schedule). Partner with Global Trial Manager to determine availability of selected PRO instruments and their translations for inclusion in clinical trials. Partner with clinical teams/Global Trial Managers concerning creation/acquisition of new translations of required PRO instruments for inclusion in clinical trials. Provide advice to clinical teams concerning validation studies required for possible modifications to PRO instruments for inclusion in clinical trials. Partner with Global Trial Manager to provide PRO support for investigator's meetings and possibly present PRO study components at those meetings. Work with trial data management to ensure validity of PRO data capture processes, including the review of data edit guidelines and data edit listings. Provide PRO instrument scoring algorithms to clinical trial statistical programmers. Provide published materials instrumental to the interpretation of selected PRO measure results to clinical team for inclusion in protocols, statistical analysis plans, and clinical study reports. Participate in preparing relevant sections of documentation and communication for regulatory agencies in support of submission activities. Assist in the preparation of abstracts and manuscripts presenting PRO results from clinical studies. Identify, evaluate and manage projects with researchers and PRO vendors external to the company, including but not limited to qualitative research (focus groups, etc.), cultural validation studies, validation studies for special populations, etc. Maintain a list of key opinion leaders available for consultation on selected PRO projects. Conduct medical and health outcomes literature reviews. Provide training on internal PRO implementation process to clinical and other teams. Manage budgets and contracts for PRO projects for assigned products.With PRO Leader, help ensure that knowledge gained from efforts on these PRO activities is captured in a shared electronic PRO repository. Education/Experience: Minimum of a PhD or PharmD with at least 2 years experience in clinical research in the pharmaceutical industry or contract-service organization, with at least 1 year in outcomes research is required. Or a Masters degree in appropriate field (Psychology, Sociology, Health Economics, Biostatistics, Epidemiology, Public Health Administration, Health Services Research) with a minimum of 3 years experience in clinical research in the pharmaceutical industry or contract-service organization, with at least 2 years in outcomes research is required. Must have experience with Patient Reported Outcomes Research. Certification/Training:1. Relevant courses of study/training include research methodology, psychometric evaluation, biostatistics, clinical trial design or epidemiology.2. Project management training is an asset Other Requirements:1. Experience in clinical trial research is required.2. Some experience in the conceptual basis, methodology and application of PRO and other health outcome measures in the context of clinical studies, observational studies, or population level surveillance is preferred. 3. Prior project management experience is preferred.4. Strong knowledge of cultural and linguistic validation processes is preferred. 5. Familiarity with the FDA Draft Guidance for Industry on PRO measures and with the EMEA CHMP Reflection Paper on the Regulatory Guidance for the Use of HRQL Measures is preferred. 6. Familiarity with electronic data capture in clinical studies is preferred. 7. Must possess superior communication and interpersonal skills in order to interact appropriately with members of the organization at all levels and responsibilities. 8. Must be capable of leading and working effectively as a member of multidisciplinary teams.9. Ability to travel at least 10-15% domestically and internationally is required. If you want to explore the many small-company environments behind the big-company impact of the Johnson && Johnson Family of Companies, bid on this position today! Apply Now