Associate Director Scientist

Overview

Orion Group Life Sciences are looking for an Associate Director Real World Evidence Scientist for our Multinational Pharmaceutical client based in Maidenhead. This is for an initial 6-month contract, with possibility of extension. This is a hybrid position.

The Associate Director RWE Science is a senior professional within the Center of Outcomes Research and Epidemiology (CORE) function responsible for the development and conduct of real-world research. The Associate Director RWE Science supports the Senior Director of CORE in defining the short to medium term strategic direction for, and implementation of, the RWE research plan and Medical Affairs strategy and plan of our client.

The role provides independent methodological and technical leadership. The role covers multiple complex studies which may switch between product portfolios over time or run in parallel. Problems faced are often complex and require extensive investigation and analysis. The role works in a matrix environment involving cross-functional collaboration with global and regional teams in Medical Affairs, Commercial and R&D. The role provides global external representation in scientific forums and supports industry and regulatory engagement.

• The Associate Director RWE Science supports the Senior Director of CORE in defining the short to medium term strategic direction for, and implementation of, the RWE research plan and Medical Affairs strategy and plan of our client. Liaises with internal stakeholders including Global and Regional Medical Affairs functions, Market Access, Project Management, Clinical Development, Commercial, Regulatory Affairs, in a matrix environment for planning or to maximise the value proposition of late-phase or marketed products of our client according to strategic objectives.
  
  Represents CORE for relevant topics in the cross-functional forums.
• Contributes to development of best practices and methodologies in real-world evidence and epidemiology research with focus on ensuring the research program design meets scientific objectives, and optimal analysis and data collection tools are utilized.
• The role independently leads, or oversees the work of direct reports, for project wide planning and implementation of complex RWE studies and models, including feasibility assessments, go-no-go criteria, authoring key sections of protocols, study reports and submission documents to be included in registration or reimbursement files. The role manages an assigned team of internal and external research staff who lead, or support sponsored by our client and co-led, Phase IV real world research programs.
  
  Provides technical and methodological expertise to the generation, analysis and interpretation of RWE and explores novel study designs, liaising with external experts as required.
• The role ensures effective risk management for achieving objectives with the highest data quality possible at acceptable costs within budget and lowest possible risk for assigned research programs and projects. Oversees the quality and timely delivery of any work commissioned externally via CROs and consultants.
• Manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the FDA, World Health Organization, country and regional regulations for the reporting of adverse events to regulatory agencies.
• Responsible for and contributes to the writing of relevant components of regulatory dossiers and product related documents (PSURs, RMPs etc.) through authoring and review of key sections for observational studies/epidemiological data and provide oversight to contributions from CORE as relevant.
• In case of post-marketing commitments, to ensure that the response to such a commitment is effective and adequate. Provide advice on the epidemiological aspects of regulatory submissions. Remains current on standards for Good Epidemiology Practice and other standards within the biopharmaceutical industry related to compliance and best practices for conduct of epidemiologic studies.
• Contributes to the interpretation, dissemination, and integration of complex real world evidence to support products of our client and contributes to health authority and NITAG submissions (pre and post launch). Prepares or oversees the preparation of abstracts, posters, oral presentations, and written reports to effectively communicate results of epidemiological programs and studies to internal and external stakeholders and colleagues with varying levels of epidemiologic research knowledge.
  
  Prepare manuscripts for submission to peer-reviewed journals.
• Participates in meetings with health authorities and the scientific community, network with thought leaders, regulatory and international agencies for assigned topics and forums, interactions with vaccine advisory bodies, as required. Provides additional data summaries for publications, presentations, posters, and…