This role entailed the following:
A) Product-development safety surveillance aspects
- Global-safety project-representative on clinical-matrix teams providing safety-evaluation and risk-management expertise (in support of 4 complex transformational assets with overlapping development (led from phase-IIa to submission), plus all novel Respiratory excipients/ternary agents in clinical development. Also provided product-area safety strategies to key internal stakeholders (safety Boards, expert panels etc.), and maintained Project-risk-registers for annual Portfolio-funding reviews.
- Project Safety-review-team Leadership (3 matrix-based teams) of proactive safety-evaluation activities ensuring systematic approaches to clinical-safety-data monitoring. Key deliverables included:
- determining safety end-points and risk-minimisation strategies for clinical-development programmes to meet global compliance, regulatory-filing requirements,
- and drive the implementation of risk-management initiatives.
- pioneering a new signal-detection tool for near-real-time trial data analysis.
B) Compound development and Regulatory aspects
- Recurrent author/approver of safety updates for submission documents (IND/NDA annual reports, EU Annual Safety Reports) and of safety-strategy sections of milestone-related Regulatory documents (pre-IND/NDA briefs, paediatric investigation plan, EU Scientific advice, Japanese IND etc.); I also participated to Regulatory meetings (EMEA and France).
C) Safety Operations aspects
- Responsible for the production/implementation at project level of Development Safety Update Reports.
- Designed the process and led the implementation of the then new FDA INDSR requirements.
- Led cross-functional process-redesign initiatives and rationalisation of clinical-trial data capture (R&D-wide impact and savings).