Director Epidemiolgy and Phase IV Studies

Title: Director Epidemiolgy and Phase IV StudiesReq: 01047Location: Gaithersburg MDMajor Duties and Responsibilities:1. Responsible for the development and implementation of Phase IV clinical/epidemiological research and related cross-functional communications (Medical Affairs Commercial Sales and Marketing HOPE and Therapeutic Heads). Coordination with regulatory affairs on post marketing commitments and maintenance of timelines/deliverables.2. Serve as a project director for Phase IV clinical/epidemiological research and contribute to safety assessment of marketed products.3. Initiate and coordinate labeling update for marketed products and participate in review of scientific communications. 4. Provide scientific input as needed to research/discovery clinical development commercial operations HOPE product safety and business opportunities and represent company at medical conferences/conventions and/or symposia; interfacing with key customers treatment centers influential physicians and key opinion leaders. Solid understanding of regulatory guidance and requirements in post marketing research.5. Proven leadership skills and ability to interact in matrix management type team structure. Strong oral and written communications skills.6. Manages activities and resources associated with phase IV clinical and epidemiology studies conduct clinical line listing review liaison with project management regarding post marketed projects and biostatistics regarding analytical requirements to achieve stated objectives and exploratory analyses.7. Represent company at national and international meetings as necessary as well as major advisory boards. Promote MedImmune’s focus on pediatric research and support research on disease burden. 8. Support SOPs work practices and guidelines with guidance and input into processes and write work practices guidance and/or internal educational presentations.9. Identify vendors for support of Phase IV/epidemiologic research as necessary give scientific advice and participate in RFI/RFP process. Ability to provide estimated budget/costs for research projects and propose designs in a cost effective manner.10. Keep abreast of clinical and epidemiological research methods within academia regulatory and key opinion leaders related to infectious disease and/or pediatrics.11. Work closely with Director of Phase IV and Epidemiology to develop action plan departmental updates on phase IV projects input into strategic plans and assure timely publication of materials and execution of external publications.Experience:A MD PhD or PharmD with public health training specializing in epidemiology biostatistics and/or clinical trial design. Experience in Infectious Disease research. Extensive experience in clinical trials design with a minimum of 5 to 10 years clinical/epidemiological research experience within industry. Must have at least 5 years of experience interacting with regulatory authorities (FDA ICH EMEA). Therapeutic area knowledge in either vaccines or monoclonal antibodies preferred as well as pediatric research.Special Skills/Abilities: In depth understanding and experience in post marketing clinical research (surveys registries retrospectives and prospective designs cross sectional study design) and epidemiological methods data analysis and understanding of clinical data management process flow. Prefer experience with CTMS and EDC systems. Strong research skills and track record in scientific communications/publication. Record of productivity in design implementation analysis publication and formal presentation of research projects. Understands the interplay between clinical development and commercial objectives. Strong understanding of safety and effectiveness research. Ability to work effectively in both a team environment independently and manage extended team. Ability to work with global teams as necessary. Excellent communication (oral and written) interpersonal and organization skills. Results oriented and delivery focus with adherence to timelines goals and objectives. Experience in product lifecycle (biopharm industry R&D - i.e. major milestones and factors influencing decision points) and development within the industry. Knowledge of FDA ICH CIOMS and GCP guidelines. Job Complexity: Works on problems and special projects of diverse scope and complexity. Exercises independent judgment within generally defined practices guidance and policies. Ability to perform all tasks as assigned in a timely manner according to Medical & Scientific Affairs and company SOPs and work practices.Supervision: Minimal or no supervision depending upon assigned projects and tasks. Liaison with program managers clinical operations biostatisticians and outside vendors and provide leadership to teams.Educations: MD PhD or PharmD with public health training specializing in epidemiology biostatistics and/or clinical trial designCLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Director Epidemiolgy and Phase IV Studies Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Biotechnology and Pharmaceutical