Director, Bioethics

Director, Bioethics

Location: Warsaw, 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 Senior Director, Bioethics and acts as a functional Leader in relation to optimizing, simplifying and standardizing procedural documents at enterprise level, and is responsible for representing the Team in interactions with the broader organization.

Responsibilities includes delivery of leading the development of enterprise applicable principles of areas under the Bioethics Process, chairs and contributes to working groups and governance boards, oversight Bioethics E2E processes and internal websites and. The role acts as the Business Process Owner, and oversees the development, improvements and implementation of processes in the Bioethics process area. The interactions spans across all TAs and phases of development lifecycle of a compound from discovery to commercialisation, incl. external interactions and requires excellent communication and stakeholder management.

Typical Accountabilities:

All or some of the specific accountabilities applies to the job holder, as fit for the role.

Actively shaping the Bioethics organisation’s remit and global / regional strategic direction. Provides proactive, strategic Bioethics advice to senior leaders across the enterprise. Partner with stakeholders and TA/Indication functions across enterprise to help establish state of the art 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 stakeholders to influence the overall direction for programmes, projects and services to achieve compliance with principles set and mitigate high level risks. Ensure monitoring of the regulatory landscape and conduct impact assessment of business and regulatory requirement changes. Lead, builds and establishes cross functional enterprise encompassing governances/workings/frameworks for the respective areas and contribute to the development of the enterprise E2E Bioethics strategy. Leads and oversees compliance and risk management of all procedural documentation in line with applicable regulatory and AZ requirements. Acts as a Business Process Owner and is responsible for Bioethics owned procedural documents are compliant with law and regulations and are continuously improved and implemented. Liaise with other BPOs, BPALs, Document Owners, Authors, Business Learning Leads (BLLs) and functional support to manage links with related processes and procedural documentation. Authors relevant data standards and business continuity plan for the process, if required Assess impact of and communicate process changes. Oversees and developes training materials, expert advice, coaching and shares good practice. Oversees and leads development of project status reports reflect on the complete and current project information across working groups and boards. Interface with Strategic Partners and other Third-Party Vendors & External Service Providers (ESPs) as well as internal cross-function teams to complete activities relating to the assigned processes, systems and projects Promote adherence to the process across the enterprise and drive continuous improvements. Define Key Performance Indicators; monitor performance, identify issues and risks, escalate as required, to ensure the process deliver the desired outcome. Liaise with relevant IT System Owner(s) or delegates and other key stakeholders to ensure alignment. Contributes to Global Advisory Groups and and Governance Boards such as BioEthics and chairs working groups

General Accountabilities:

Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines Drives, promote and embeds a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits Communicates effectively with Bioethics colleagues and cross functional business stakeholders at all levels Maintains knowledge of relevant industry information affecting trial transparency arena Leads training for colleagues and business stakeholders as required.

Education, Qualifications, Skills and Experience:

Essential:

Master’s degree or equivalent qualification in relevant scientific discipline Extensive experience in Policies, Procedural Documents, and Clinical Development Pharmaceutical experience Ability to effectively communicate with stakeholders within AstraZeneca Working in a global, complex cross functional role Significant experience in pharmaceuticals or a related industry Excellent analytical, written and oral communications skills Fluent in written and spoken English High ethical standards and integrity High intercultural awareness Strong collaborative, influencing and interpersonal skills – curious to understand business environment Skilled at managing & using technology Ability to maintain and create professional networks with stakeholders

Desirable:

Project management experience Driving and implementing strategic initiative Passion for structure and simplifications Key Account management Policy writing Quality Management PhD in scientific discipline Expert reputation within the business Extensive knowledge of the latest technical and regulatory expectations

Date Posted

12-Jun-2024

Closing Date

26-Jun-2024

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