Director, Bioethics
Location: Barcelona, hybrid work: 3 days from the office, 2 days from home
The Chief Medical Office (CMO) Bioethics delivers R&D standards that guide the ethical development and delivery of medicines to patients. The job holder reports to the Senior Director, Bioethics and acts as a functional leader in relation to optimizing, simplifying, and standardizing procedural documents at the enterprise level. The role is responsible for representing the team in interactions with the broader organization.
ResponsibilitiesResponsibilities include leading the development of enterprise applicable principles in areas under the Bioethics Process, chairing and contributing to working groups and governance boards, and overseeing Bioethics E2E processes and internal websites. The role acts as the Business Process Owner and coordinates the development, improvements, and implementation of processes in the Bioethics process area. Interactions span across all TAs and phases of the development lifecycle of a compound from discovery to commercialization, including external interactions, and require excellent communication and stakeholder engagement.
Typical AccountabilitiesActively shape the Bioethics organization's remit and global/regional strategic direction.Provide proactive, strategic Bioethics advice to senior leaders across the enterprise.Partner with collaborators and TA/Indication functions across the enterprise to establish innovative principles and standards to enable the right balance of efficiency, flexibility, and value across TAs and indications.Lead the provision of deep subject matter expertise for internal collaborators to influence the overall direction for programs, projects, and services to achieve compliance with set principles and mitigate high-level risks.Ensure monitoring of the regulatory landscape and conduct impact assessments of business and regulatory requirement changes.Lead and establish cross-functional enterprise governance/workings/frameworks for the respective areas and contribute to the development of the enterprise E2E Bioethics strategy.Supervise compliance and risk management of all procedural documentation in line with applicable regulatory and AZ requirements.Act as a Business Process Owner and ensure Bioethics-owned procedural documents are compliant with laws and regulations and are continuously improved and implemented.Liaise with other BPOs, BPALs, Document Owners, Authors, and Business Learning Leads (BLLs) to handle links with related processes and procedural documentation.Author relevant data standards and business continuity plans for the process, if required.Assess impact of and communicate process changes.Oversee and develop training materials, provide guidance, coaching, and share best practices.
#J-18808-Ljbffr
