Experience

Kezar Life Sciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• SVP, Head of Clinical Development, Member of Executive Team

  • May 2023 - 8 months

  San Francisco Bay Area * Oversee Medical Science, Medical Affairs, Operations, Biostatistics and Stat Programming, Data Management, Pharmacovigilance * Mentor Project Team Leaders * Interface with Board of Directors



Kronos Bio

• United States
• Biotechnology Research
• 1 - 100 Employee

• Hematology Franchise Leader, VP Development Operations, Portfolio Management, Biometrics & Quality

  • May 2020 - May 2023

  San Mateo, California, United States * Lead a cross functional senior leadership team to develop and prioritize long term clinical development strategy (10 years horizon) in hematology/oncology. * Drive complex multi years multi millions dollars global sourcing strategy. * Responsible for functional due-diligence of in-licensing assets including large scale in-bound data migration * Oversee a number of key functions in clinical development: Clinical Operations, Portfolio Program Management, Data Management… Show more * Lead a cross functional senior leadership team to develop and prioritize long term clinical development strategy (10 years horizon) in hematology/oncology. * Drive complex multi years multi millions dollars global sourcing strategy. * Responsible for functional due-diligence of in-licensing assets including large scale in-bound data migration * Oversee a number of key functions in clinical development: Clinical Operations, Portfolio Program Management, Data Management, Biostatistics, Vendors Alliance Management & Strategic Sourcing, Clinical Quality, PV, and development IT infrastructure * Member of R&D Leadership Team, Chair CRO oversight governance committee Show less



Jazz Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Vice President, Clinical Operations, Data Management, Strategic Sourcing, Vendor Contracts

  • Sep 2018 - Mar 2020

  Palo Alto, Philadelphia, UK Sites * Department Head of clinical operations, data management, vendor management and sourcing (~70 staffs). Grow department by 40% within 1 year across Palo Alto, Philadelphia, and UK sites. * Oversee diverse therapeutic areas includes CNS and hematology/oncology, oversee the department’s in-licensing due-diligent assessment. * Manage a large development portfolio with annual spend ~$150million. * Member of R&D Executive Leadership Team and Executive Development Portfolio Review… Show more * Department Head of clinical operations, data management, vendor management and sourcing (~70 staffs). Grow department by 40% within 1 year across Palo Alto, Philadelphia, and UK sites. * Oversee diverse therapeutic areas includes CNS and hematology/oncology, oversee the department’s in-licensing due-diligent assessment. * Manage a large development portfolio with annual spend ~$150million. * Member of R&D Executive Leadership Team and Executive Development Portfolio Review Committee. * Sponsor a large R&D initiative which aims to accelerate clinical development. Closely involve all R&D functions as well as IT, finance, legal, patient advocacy, portfolio management, and technical operations. Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Director, Oncology Therapeutic Head, Early Clinical Development Operations

  • Jun 2014 - Jun 2018

  South San Francisco Set long-term 10 years vision, led multiple enterprise-wide initiatives aimed at shaping internal strategy and external partnerships to accelerate the development of novel medicines. Led mid size department (>70 staffs), rigorously reviewed study design, CDP, and data output to accelerate portfolio development. * Manage a large portfolio of >15 molecules in clinical development and annual spend ~$130million. • Strategic Partnership: Partnered with executives across 5 Roche &… Show more Set long-term 10 years vision, led multiple enterprise-wide initiatives aimed at shaping internal strategy and external partnerships to accelerate the development of novel medicines. Led mid size department (>70 staffs), rigorously reviewed study design, CDP, and data output to accelerate portfolio development. * Manage a large portfolio of >15 molecules in clinical development and annual spend ~$130million. • Strategic Partnership: Partnered with executives across 5 Roche & Genentech R&D units to establish unique strategic alliances with 25 leading cancer centers to advance scientific knowledge & accelerate portfolio development. Roche’s Press Release: https://www.roche.com/media/store/releases/med-cor-2016-11-15.htm. • Internal Strategy: co-developed strategy leading to innovative, accelerated, and adaptive development plan. A number of molecules are on accelerated path to registration. • Speed & Cost Saving: Across portfolio, reduced trial activation time by almost half, nearly doubled enrollment rates, record first patient enrolled in 3 weeks from IND clearance versus historical median time of 6 months. Multi-millions dollars annual saving. • Innovation: Defined digitization strategic roadmap to enable extreme study activation (goal <1 week), significantly reduce internal and external resources, and gain deeper insight into different patient segments. Directed data analytic team to enhance predictive analytic modeling to optimize program planning accuracy. • Data Quality: Unequivocal data readouts across portfolio for rapid adaptive clinical decisions, tissue evaluability improved from <70% to 85% to optimize reverse translational research. • Vendor Strategy: Transformed 3 global CRO & Central Labs strategic alliances to handle rapid and complex development, enhance interface with research sites and therapeutic learning. Delivered >90% of projects, CRO staff turnover reduced to 4% (versus average of 25%), enforced fix-priced contracts.

• Director, North America Regional Head, Oncology Therapeutic Area, Late Stage Development

  • Jul 2010 - Jun 2014

  South San Francisco Broad oversight of large team across 3 headquarter sites (~100 staffs). Established broad collaborations across enterprise to enhance life-cycle development and deepen the relationship with academic and community investigators. Served as senior reviewer on development review committee. • Organizational Integration: Integrated 3 distinct organizations within 1 year while portfolio progressed without interruption and staff retention stayed at 95%. Improved resource efficiency by >25%… Show more Broad oversight of large team across 3 headquarter sites (~100 staffs). Established broad collaborations across enterprise to enhance life-cycle development and deepen the relationship with academic and community investigators. Served as senior reviewer on development review committee. • Organizational Integration: Integrated 3 distinct organizations within 1 year while portfolio progressed without interruption and staff retention stayed at 95%. Improved resource efficiency by >25%. Achieved top quartile employee engagement score in a corporate survey. • Collaboration: Collaborated with 2 early development (ED) units to run complex ED trials. Initiated collaboration with field Medical Science Liaisons (MSL) to broaden scientific engagement with a large number of investigators. This served as a model for global MSL involvement across development portfolio. Initiated site alliance strategy to support life cycle development from first-in-human to phase IV; engaged internal and external executives to advance collaborations. • Strategic Guidance: Rigorous reviewed protocol design and CDP to optimize competitiveness. • Precision Medicine: Engaged internal and external executives to explore various comprehensive biomarker testings to preserve patient’s tissues and determine optimal treatments. • Anti-counterfeit: Core member of corporate anti-counterfeit task force which set overarching policy for both commercial and clinical interactions with sites purchased counterfeit medicines.

• Associate Director, Clinical Program Management, Late Stage Oncology Global Development

  • Dec 2008 - Jun 2010

  Strategic input into long-range portfolio planning and oversight of mid to late stage porfolio. • Portfolio Strategy & Execution: Served as senior reviewer on Development Review and Franchise Committees to expand portfolio to a large number of phase II & III company-sponsored and academic-cooperative programs. • Oncology Disease Strategy: Initiated 7 disease teams to derive future strategies for the diseases. • Manufacturing: Involved in 10 drug manufacturing “Class A” initiatives… Show more Strategic input into long-range portfolio planning and oversight of mid to late stage porfolio. • Portfolio Strategy & Execution: Served as senior reviewer on Development Review and Franchise Committees to expand portfolio to a large number of phase II & III company-sponsored and academic-cooperative programs. • Oncology Disease Strategy: Initiated 7 disease teams to derive future strategies for the diseases. • Manufacturing: Involved in 10 drug manufacturing “Class A” initiatives aimed at transforming production planning, supply chain, inventory management, and global labeling process.

• Senior Clinical Program Manager, Late Stage Development

  • 2003 - Dec 2008

  Oversight of large late stage clinical program (Avastin) with annual budget multi-millions dollars and >8-year life cycle span. • Portfolio Strategy: Contributed to long-range life cycle planning to expand Avastin label to several new indications: breast, renal, brain, ovarian, and prostate cancers. Explored different combination therapies. Member of Joint Clinical and Project Leadership Teams in collaboration with Roche as ex-US partner. • Portfolio Execution: Managed a portfolio… Show more Oversight of large late stage clinical program (Avastin) with annual budget multi-millions dollars and >8-year life cycle span. • Portfolio Strategy: Contributed to long-range life cycle planning to expand Avastin label to several new indications: breast, renal, brain, ovarian, and prostate cancers. Explored different combination therapies. Member of Joint Clinical and Project Leadership Teams in collaboration with Roche as ex-US partner. • Portfolio Execution: Managed a portfolio included >12 company-sponsored and complex academic-cooperative phase II and III programs. Delivered aggressive corporate goals year-after-year. Oversight of a large portfolio of hundreds of investigator-initiated trials.



Abgenix (bought by Amgen)

• Senior Clinical Program Manager, Early Development

  • 2001 - 2003

  Oversight of the development of panitumumab (Vectibix; EGFR antibody) in renal and GI cancers. Involved in business development activities. Oversight of the development of IL-8 antibody in chronic obstructive pulmonary disease (COPD). Provided in-depth review into Go/No decision review leading to program termination. Managed a team of 8.