TA Director, Risk Management Lead Multiple Therapeutic Areas (Hybrid)

The TA Director of Risk Management Leads is responsible for overseeing and advancing risk management strategy practices and performance across clinical development portfolios within Immunology Neuroscience Aesthetics /Eye Care /Specialty therapeutic areas. This leader drives risk identification assessment mitigation and monitoring ensuring a critical-to-quality data-driven approach is embedded in protocol design and study operations. By developing and leading a high-performing team of Risk Management Leads the TA Director ensures effective oversight RAMP accountability and continuous improvement in risk management practices with a specific focus on addressing resource gaps related to RAMP entry work and the implementation of risk-based study modifications.

Key Responsibilities:

• Drive portfolio-level risk identification and mitigation strategies in partnership with therapeutic area teams enhancing proactive management of study and program risks.
• Support and collaborate with the Integrated Evidence Strategy Team (IEST) to embed critical-to-quality elements into protocol design ensuring data collection is focused on decision-making needs.
• Lead develop and mentor a team of Risk Management Leads fostering expertise collaboration and innovation in risk-based quality management.
• Oversee the development and execution of therapeutic area risk insights dashboards and mitigation plans promoting a deep understanding of risk drivers and solutions.
• Ensure robust RAMP (Risk Assessment and Mitigation Plan) processes tracking accountability and ensuring timely data-driven risk action planning.
• Address resource gaps by overseeing RAMP entry work and supporting the implementation of risk-based modifications to the scope of studies assigned to Study Risk Leads (SRLs) advocating for full resource needs where required.
• Collaborate with cross-functional stakeholders (including Clinical Site Management Clinical Study Leadership Data Science and Compliance) to ensure alignment and consistency in risk management practices.
• Contribute to the development standardization and continuous improvement of risk management best practices metrics and training across the organization.

Impact and Influence:

• Deepens portfolio and program risk management capabilities and accountability.
• Leads a critical-to-quality focused approach to data collection supporting pipeline decision-making on sound data.
• Supports a culture of continuous improvement transparency and evidence-driven risk mitigation.

**This is a hybrid position working on-site T-TH.  Candidates must be local to Marlow.

Qualifications :

• Minimum of a bachelors degree in life sciences healthcare pharmacy nursing or a related field; an advanced degree (Masters PharmD PhD MD) is strongly preferred.
• Senior experience in clinical research clinical operations or study/data risk management with experience in a leadership or people management capacity.
• Demonstrated expertise in risk-based quality management (RBQM) including experience applying ICH-GCP E6(R2) risk-based methodology and risk management best practices in clinical development.
• Direct hands-on experience with portfolio-level risk assessments Risk Assessment and Mitigation Planning (RAMP) and implementing risk-based modifications across multiple clinical programs/therapeutic areas.
• Strong knowledge of relevant regulatory guidelines (FDA EMA ICH) Good Clinical Practice (GCP) and global health authority requirements for clinical trials.
• Professional risk management certifications are highly desirable (e.g. ASQ Certified Manager of Quality & Organizational Excellence Chartered Enterprise Risk Analyst (CERA) Certified Risk Manager (CRM) Professional Risk Manager (PRM) ASQ Risk Management Specialized Credential or equivalent experience).
• Experience with critical-to-quality (CtQ) elements protocol design input and collaboration with evidence strategy teams preferred.
• Demonstrated success developing mentoring and leading teams preferably in a matrixed global environment.
• Advanced skills in data analytics dashboarding and the use of data visualization tools (e.g. Excel Power BI Tableau) for risk oversight and decision-making support.
• Excellent interpersonal skills; able to communicate complex concepts clearly persuade stakeholders and foster cross-functional collaboration.  
• Grade and benefits will depend on lcoal country 

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time