The Director, Clinical Epidemiology is a key senior leadership position responsible for providing strategic leadership for and managerial oversight of the Department of Epidemiology to add value to global CSL projects. The role leverages expertise in epidemiological and benefit-risk assessment research methodologies to create strategies that optimize the contribution of these disciplines to ensure robust, evidence-based decision making and provides solutions with substantial direct operational and financial impact.
The role oversees epidemiology contributions across TAs and manages global deliverables.
The role interacts with peers in a global matrix environment organization to ensure superior cross functional performance, participates in global scientific and leadership teams, and interacts with regulatory agencies in multiple countries. It also involves management of personal and project budgets, and may involve oversight of the activities and deliverables of external contract research organizations.
•Provide leadership and guidance to facilitate ongoing development and growth of the Department of Epidemiology to support global CSL projects aligned with corporate strategic objectives
•Oversees members of the Department of Epidemiology to provide input to clinical development plans and clinical study protocols to inform target population selection, incidence rates for sample size calculations, or novel study designs to optimise trial execution (reduced cost, shortened duration, lower risk).
•Oversees members of the Department of Epidemiology to oversee design and implement of observational studies conducted by CSL or, when working with external vendors, ensures highest quality deliverables from vendors to meet program needs
•Responsible for aligning objectives across functions within the Department of Epidemiology and to ensure optimal resource allocation to meet strategic objectives and project priorities
•Provides input to Risk Management Plans for marketed products where epidemiologic studies (e.g. observational studies, registries, etc) are ongoing or where epidemiologic expertise is required and designs newly required/planned epidemiologic studies.
•Responsible for final review and approval for sections of Risk Management Plans for which the Department of Epidemiology is responsible or impacted.
•Fosters a leadership culture which attracts, develops, and retains high caliber individuals with expertise in epidemiology capable of and committed to providing valuable and creative input to CSL projects to achieve or exceed company goals.
•Contributes to the ongoing evaluation of the development strategy and progress of R&D development programs through participation in relevant committees (i.e. Project Review Committee, etc.).
•Develops networks with external parties (key experts, contract research organisations) as pertains to Pharmacoepidemiology to support key R&D programs, such as technical experts to advise on study design and participation in advisory boards.
•Interacts with Commercial Development and Heath Economics functions to provide epidemiologic support to maximize the value proposition of late-phase or marketed CSL products according to strategic objectives.
•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.
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