Manager, Bioethics (permanent/secondment)

Manager Bioethics

Location: Warsaw, hybrid work: 3 days from office per week

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 Manager, Bioethics (MB) oversees, supports, and coordinates Bioethics activities, contributing to the operational activities to ensure consistency and quality of deliverables in time. The CPM leads and manages the operational Single Patient Compassionate Use (SiPCU) E2E process, ensuring delivery to quality, time, and budget, including identification and implementation of simplification measures.

The Bioethics portfolio includes the SiPCU E2E process, procedural documents governed under the CMO Bioethics Process Area as part of the Bioethics Framework. The MB interfaces with global and local teams, cross-functional teams, and those external to the Company. As a technical and process champion, the BM is the point of contact to provide guidance on best practice. The BM oversees the system and leads the SiPCU operational E2E process management, ensuring KPIs are met to planned time, budget, and quality, including identification and implementation of simplification measures. The MB is responsible for maintaining guidance documents, including planned deviations, amending, and driving the change where appropriate.

The MB acts as a functional Leader in relation to the administrative, technical, and execution support provided by GBS. As a functional Leader, the MB is responsible for representing the Team in interactions with the broader organization, role models, and fosters inclusive, innovative, and collaborative ways of working.

Typical Accountabilities:

Procedural Documents & Critical RD Master Templates

• Act as the main point of contact and oversee the quality of work, contributing to the effective operation of the team through liaison and discussion with team leaders.
• Manage the guidance documentation, ways of working, and procedures for the allocated area of responsibility.
• Contribute to governing and updating procedural documents, planned deviations incl. appropriate documentation in line with respective Standards and SOPs.
• Manage aspects of projects within own specialist area.
• Ensure a full understanding of how own function contributes to achieving the objectives of the business.
• Use own functional knowledge to deliver high standards, with an increasing freedom to act without direct supervision.
• Interface with 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.
• Lead the setup, maintenance, and archiving of procedural documents incl. planned deviation under CMO RD BPA Framework within ECSM partnering with the respective learning and technology team, RD governance team, and Business Learning Leads in line with the Company SOPs and processes.
• Provide input into functional work including training activities and development of procedures, guidance, and ways of working and capability development.

Reporting and Metrics

• Lead and manage the bi-annual update of stakeholder report (e.g. CMO governance board AtM report).
• Lead and manage the annual geo-governance update incl. identification and implementation of simplification measures.
• Report on project status and participate in project planning and control activities to ensure project plans remain up to date.
• Ensure project status reports reflect on the complete and current project information.
• Monitor compliance and ensure reporting of issues, proactively identify risks, and proactively report all identified risks to Associate Director Bioethics and Senior Director Bioethics.
• Provide execution and operational expertise within all allocated area of responsibility.

CMO Single Patient Compassionate Use (SiPCU)coordinator

• Lead SiPCU E2E operational process including requests related communication coordination, supporting the review of SPEA enquiries and request, CMO Operational Due Diligence, updates of process metrics, monitoring initiation of resupply requests, and acting accordingly.
• Oversee and take action on the early access mailbox.
• Responsible for CMO Operational Due Diligence of every SiPCU request received through CyberGrants.
• Coordinate the SPEA cross-functional team interactions required for granting SiPCU to Investigational Medicinal Products incl. GBS.
• Act as a point of contact for SPEA operational enquiries.
• Act as the main point of contact for the GBS team, ensure the GBS team is appropriately trained and follows the agreed process.
• In collaboration with the GBS team and other internal stakeholders, identify and act on areas of improvement and simplification.
• Ensure all relevant documentation is in place for timely review and decision making of SiPCU requests.
• Track all project KPIs from a time, cost, and quality perspective, providing progress reports to Associate Director Bioethics and Senior Director Bioethics .
• Identify risks and escalate all identified risks, issues of nonperformance, and non-compliance to the appropriate person.

Education, Qualifications, Skills and Experience:

Essential:

• Minimum 3 years’ experience in clinical experience working with international teams.
• Bachelor’s degree in biological science or healthcare-related field.
• Solid knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines.
• Excellent written and verbal communication skills as well as proven collaboration and influencing skills.
• Excellent knowledge of spoken and written English
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Proactively identify risks and possible solutions
• Demonstrated ability to set and manage workload priorities, resources, performance targets and project initiatives for projects or teams.
• Demonstrate ability to work independently, as well as in a team environment.
• Ability to identify and champion more efficient and effective methods/processes whilst operating with required policies and regulations.

Desirable:

• Working knowledge across the RD and Medical Affairs an understanding of the range of working procedures relating to them
• Demonstrate concern of standards, concern of impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, and tenacity.
• Demonstrate professionalism and mutual respect.
• Evidence of working effectively with both internal and external stakeholders across regions, functions, and cultures in a matrix organisation.
• Project Management certification, or demonstration of project management skills.