Jason Huang

Ascendo focuses on the development of a first-in-the-class innate immune checkpoint inhibitor and vaccines derived from a very versatile platform from bench to bedside.

Currently leading the Drug Development translational project management teams with medical/regulatory science/IP management backgrounds. Have demonstrated solid experienced during the career life in people development, strategic planning and clinical development. Also skillful in regional strategic planning of AP as well as translational enabling management integrating expertises of preclinical development from CMC, formulation scientist, preclinical DMPK vendors. Made strategic planning and monitor accountability for all active projects under clinical development of major pharmaceutical. Be accountable for implementation of research projects on schedule, within budget and by satisfactory standards. Can motivate people to achieve good performance and establish the supportive matrix in the team. Specialized in Asia-Pacific including China, Australia, India, SE Asia, Korea,Taiwan and Hong-kong. Directly managed a team up to 80+ people in three countries before and currently lead / engaged in 5 active translational enabling projects ranging from ophthalmology indications, Osteoarthritis and therapeutic vaccines / immune checkpoint large / small molecules to normalize the immuno-exhaustation status of cancer patients and patients with chronic viral infection. All are First in the class with novel MOA. Can do very efficient translation enabling project management to speed up the compound development from bench to clinical POC with great efficiency. Current company had achieved two US-FDA IND submission within 1.5 and 2.5 years consecutively after licencing in from academias.

Core Job: 1. Collaborates with the study placement group and the local team to validate/update epidemiologic data gathered centrally 2. Collaborates with the Global Enrolment Strategy group and local team to validate/update regional KOL/intelligence database 3. Able to engage directly in peer to peer contacts and build and maintain strong partnerships with KOLs, sites, local experts, academic groups in the region 4. Has a good understanding of the standard of care in the region, the different health care systems and is able to assess potential impact on TA programs, reference drugs and is able to advise central teams on the future strategy for the region 5. Support the central and local teams in ensuring good training on project related knowledge 6. Find and develop new sites as required by Therapeutic Areas and future clinical trial demands in order to maximize on country and regional performance in clinical trials 7. Provide central teams with consolidated input from the regions on protocol proposals/outlines (do-ability) and identify factors for successful recruitment and country selection (scenario building). 8. Ensure optimal country/site selection for successful execution 9. Consolidated proposal of country/site selection balancing maximizing on the true potential of a country, recruitment potential and speed and quality. Define back up strategy. 10. Accountable for all agreed qualitative/quantitative metrics for the region Competencies 1. Good scientific and medical expertise enabling peer-to-peer connections with KOLs 2. Broad experience in the pharma industry and drug development 3. Good knowledge of Janssen R&D 4. Solid knowledge of ICH-GCP, GCO SOPs and relevant regulations 5. Excellent interpersonal skills and ability to demonstrate leadership 6. Internal and external partnering 7. Ability to influence clinical research strategies8. Strong problem solving ability

1. Clinical trial ideal discussion / planning / trial allocation / execution from phase 0 to phase 4 2. Connection with scientists / medical KOLs / regulatory bodies for external collaboration and innovation partnership 3. Establish the early phase clinical operation momentum in Asia

1. Clinical trial ideal discussion / planning / trial allocation / execution from phase 0 to phase 4 2. Connection with scientists / medical KOLs / regulatory bodies for external collaboration and innovation partnership