Executive Director, Oncology Biologics Cmc Project Leadership
Current• Accountable for the Oncology biologics portfolio of CMC programs and their CMC strategies from research transition through to first wave of submissions and CMC launch support. • Member of Biopharmaceutical Development (BPD) leadership team, BPD governance, and other governance bodies for therapeutic areas and operations.• Direct manager of the CMC Project Leaders who lead CMC matrix teams for Oncology biologics products.• Responsible for assessing key trends, drivers, milestones, and supply needs for the Oncology biologics CMC project portfolio. • Provides CMC and leadership expertise to CMC teams to ensure efficient planning and delivery of company strategy.• Extensive experience with authoring and review of regulatory filings including BLA / MAA / IND / CTA. • Regulatory interaction leadership including FDA Type B, C, and post-approval feedback meetings.