Howard Tao
Strategic Biotech Program Manager with 10+ YoE
- Role
- Senior Program Manager, Product and Portfolio Strategy at Gilead Sciences
- Location
- Sunnyvale, CA, US
- LinkedIn followers
- 500 followers
About Howard Tao
Strategic Program Manager with 10+ years of experience driving global biotech life-cycle programs from discovery to commercialization. Proven success in CMC and regulatory strategy (FDA/EMA) delivering $1B in portfolio value. Expert in accelerating clinical timelines and optimizing cross-functional operations in complex regulatory environments.
Experience
Senior Program Manager, Product and Portfolio Strategy
Oct 2021 — Present
Owned the pediatric drug portfolio, leading cross-functional operations for 10+ pediatric and adult drug products from discovery through commercialization; enabled $500M+ in revenue, extended the market exclusivity by six months, and accelerated global access for children in need. Applied risk registers with root cause analysis, risk logs with scoring, and historical lessons learned to proactively plan and mitigate high-impact risks, ensuring program continuity and regulatory compliance for all products.• Collaborated with Regulatory Affairs on virology, inflammation, and oncology programs to design global release roadmaps and achieve IND/IMPD filings for Phase clinical trials. Managed development and manufacturing timelines, critical path scenario planning, budget sheets with buy-up/buy-down options, portfolio governance reviews, and commercial transition activities to secure filings (NDA, sNDA, MAA, T2V) for 6+ indications and 8+ formulations spanning 4 continents.• Conducted CMC (chemistry, manufacturing, and controls) due diligence for small molecule acquisitions: assessed risk, market value, and cost of goods to guide executive-level investment decisions. • Copiloted the implementation of an enterprise project management platform via Planisware and Smartsheets; designed dashboards, templates, and training to standardize timelines and provide leaders with real-time visibility across the portfolio.• Published a reporting suite of 60+ assets and introduced automated dashboards, cutting monthly reporting time by 40%. • Mentored interns on a resource allocation model, enhancing workforce planning throughout the clinical development lifecycle.
Education
California Polytechnic State University-San Luis Obispo
Bachelor of Science (B.S.), Biochemistry
2016
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