Shiou-Yi Ethan Chen

Medical Director at Rakuten Medical
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Location
Taipei City, Taipei City, Taiwan, TW
Languages
  • English -
  • Mandarin -

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Experience

    • United States
    • Biotechnology
    • 1 - 100 Employee
    • Medical Director
      • May 2019 - Present

      Working on clinical development of ASP-1929, an innovative photoimmunotherapy (PIT) for HNSCC and other cancer potentially Working on clinical development of ASP-1929, an innovative photoimmunotherapy (PIT) for HNSCC and other cancer potentially

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Associate Director, Medical & Scientific Affairs, Taiwan/Hong Kong
      • Jan 2017 - Apr 2019

      Promoted to director position in Jan. 2017 as medical affairs lead for Taiwan and Hong Kong; take more managerial responsibilities including: 1. leading and building TW/HK medical affairs team with MSLs and developing a Globally aligned scientific and clinical strategy that meets the Country needs with efficiently spending limited resource on medical activities 2. Engage with R&D and Commercial colleagues to ensure product development and launch excellence working cross-functionally at… Show more Promoted to director position in Jan. 2017 as medical affairs lead for Taiwan and Hong Kong; take more managerial responsibilities including: 1. leading and building TW/HK medical affairs team with MSLs and developing a Globally aligned scientific and clinical strategy that meets the Country needs with efficiently spending limited resource on medical activities 2. Engage with R&D and Commercial colleagues to ensure product development and launch excellence working cross-functionally at local and global levels 3. Ensures the highest level of PV understanding and execution cross the local organization in collaboration with the local safety officer and Regional PV Lead 4. Provide oversight of medical information activities in the country and support as required for the technical and scientific content of medical information inquiries

    • Head, Medical Affairs Taiwan/Hong Kong
      • Oct 2014 - Dec 2016

      From October 2014, I start to manage medical affairs team and expand my job scope looking after Taiwan and Hong Kong. 1. Administrative medical affairs lead in Taiwan and Hong Kong, overseeing the implementation of medical strategies in 3 business units (Facical Aesthetics, Eye Care and Neuroscience) with planned medical budget 2. Continue taking on customers-facing role as the Neuroscience/Urology therapeutic lead in Taiwan: -- responsible for a global phase IV registry (TW is the… Show more From October 2014, I start to manage medical affairs team and expand my job scope looking after Taiwan and Hong Kong. 1. Administrative medical affairs lead in Taiwan and Hong Kong, overseeing the implementation of medical strategies in 3 business units (Facical Aesthetics, Eye Care and Neuroscience) with planned medical budget 2. Continue taking on customers-facing role as the Neuroscience/Urology therapeutic lead in Taiwan: -- responsible for a global phase IV registry (TW is the only study site in APAC) -- collaborating with marketing team to launch new Urology indications successfully -- supporting market access to gain Botox reimbursement expansion to Urology (NDO, the first reimbursed indication since 2004) -- in-field hand-on injection support / training in base-indications (PSS, CD, CP, etc.) -- Support innovative IITs by medical societies and investigators in line with company medical strategies -- As a trainer to give neuroscience/urology training to the team in sub-region of APAC 3. As medical affairs lead of TW/HK, consolidating medical plans of FA, EC and NS/Urol which are aligned with commercial growth drivers to present in budget review meeting with APAC management team. 4. Have been trained with comprehensive injection skills (facial codes) and knowledge of Allergan blockbuster products (Botox, Juvederm Voluma, Vobella) (in small group master classes; launch workshop; anatomy lab; APMAC standalone meeting); being a skillful and informative expert in FA business and secondarily support the sales force, RA and clinical trial activities

    • Sr. Manager, Medical & Scientific Affairs
      • Oct 2012 - Sep 2014

      In charge of Botox in therapeutic use and eye care ( interim till 2013-April) Achievements: 1. Cross-functional -- RA: NDO and OAB approval; esp. co-working with RA team and global medical lead in the appealing for NDO labeling issue -- Clinical: as local medical monitor in a global registry study; involved in site assessment and selection; study management and monitoring along with CRO -- Access: review and input in NDO reimbursement filing, which resulted in positive… Show more In charge of Botox in therapeutic use and eye care ( interim till 2013-April) Achievements: 1. Cross-functional -- RA: NDO and OAB approval; esp. co-working with RA team and global medical lead in the appealing for NDO labeling issue -- Clinical: as local medical monitor in a global registry study; involved in site assessment and selection; study management and monitoring along with CRO -- Access: review and input in NDO reimbursement filing, which resulted in positive comments in BNHI expert meeting; -- Marketing & Sales: accomplished several injection workshops (local and regional) and company-sponsored events; handle on-demand requests and unsolicited inquiries; provide internal training and updated medical information to the team 2. Medical affairs: -- Field work: develop injectors by 1:1 hands-on skill support (injection plan, muscles to be injected, dosing) to maximize the benefit of injection for patients, which i believe is the most distinguished part for a medical role in pharmaceuticals. For new indications in urology, do TL mapping and profiling before official launch and engaging potential injectors, providing scientific evidence and planning injection workshop to educate them appropriate use and injection. -- office work: review all promotional material and advertising to ensure them compliant with company policies and pharmaceutical codes; develop educational material (external or internal use) Interim support Eye care product (mainly focus on new launched product); provide wet-lab training ( intravitreal injection) and certificate the injecting physicians; presenting in an Ad Board to differentiate and position our product in clinical treatment Company training: -- Allergan Leadership Experience 2014 (Topic: "How to Inspire to Action") -- Target Selection (part of "Managers' Essentials" training) -- Communication & Impact (part of local lead-team training) -- The Stakeholder Management Training Award for Excellence 2014

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Scientific Advisor, Oncology & Immunology
      • Dec 2009 - Sep 2012

      I entered BMS at the end of 2009. The job role of Scientific Advisor is combination of office-based and field based work, that mean, covering broad scope of daily job. There are mainly 4 aspects: 1. Being one of members in brand team to provide medical strategy and input to brand team. So I have to do internal training, review promotional material and speakers' slides, developing medical message and deliver in some events including advisory board meeting or roundtable meeting. Read and… Show more I entered BMS at the end of 2009. The job role of Scientific Advisor is combination of office-based and field based work, that mean, covering broad scope of daily job. There are mainly 4 aspects: 1. Being one of members in brand team to provide medical strategy and input to brand team. So I have to do internal training, review promotional material and speakers' slides, developing medical message and deliver in some events including advisory board meeting or roundtable meeting. Read and learn most update papers to keep brand team post of latest product information 2. Before NDA, need to co-work with regulatory affairs for like bridging study evaluation (BSE). The recent impressive cooperation is risk management plan which was requested by TFDA because biologic agents bear the risk of TB and hepatitis reactivation. As such, I was actively involved in negotiation, internal discussion and upcoming implementation of this plan. 3. Clinical trial support: for company-sponsored study, I am doing country profiling, site selection and site initiation visit. So fully understanding of investigational drug, study design, crucial issue of recruitment etc is part of my work to support clinical operation team. For Investigator-sponsored research (ISR), I was a facilitator to ensure the processes smooth. 4. For field work, I regularly visit tier-1 or 2 thought-leaders (TL) to gain medical insights and interact with them by scientific exchange, and meanwhile, profiling TLs. The communication with TLs is important because it helps to shape the market for new product and ensure appropriate and safe use of marketed drugs. Besides, well-support to market access team is also part of job by the ways of providing update data and building up good relationship with payer or reviewers. Awards: "Embrace Teamwork Awards" (2010) because of excellent support to cross functional teams "Spot Awards" (twice in 2012; one in 2011) Show less I entered BMS at the end of 2009. The job role of Scientific Advisor is combination of office-based and field based work, that mean, covering broad scope of daily job. There are mainly 4 aspects: 1. Being one of members in brand team to provide medical strategy and input to brand team. So I have to do internal training, review promotional material and speakers' slides, developing medical message and deliver in some events including advisory board meeting or roundtable meeting. Read and… Show more I entered BMS at the end of 2009. The job role of Scientific Advisor is combination of office-based and field based work, that mean, covering broad scope of daily job. There are mainly 4 aspects: 1. Being one of members in brand team to provide medical strategy and input to brand team. So I have to do internal training, review promotional material and speakers' slides, developing medical message and deliver in some events including advisory board meeting or roundtable meeting. Read and learn most update papers to keep brand team post of latest product information 2. Before NDA, need to co-work with regulatory affairs for like bridging study evaluation (BSE). The recent impressive cooperation is risk management plan which was requested by TFDA because biologic agents bear the risk of TB and hepatitis reactivation. As such, I was actively involved in negotiation, internal discussion and upcoming implementation of this plan. 3. Clinical trial support: for company-sponsored study, I am doing country profiling, site selection and site initiation visit. So fully understanding of investigational drug, study design, crucial issue of recruitment etc is part of my work to support clinical operation team. For Investigator-sponsored research (ISR), I was a facilitator to ensure the processes smooth. 4. For field work, I regularly visit tier-1 or 2 thought-leaders (TL) to gain medical insights and interact with them by scientific exchange, and meanwhile, profiling TLs. The communication with TLs is important because it helps to shape the market for new product and ensure appropriate and safe use of marketed drugs. Besides, well-support to market access team is also part of job by the ways of providing update data and building up good relationship with payer or reviewers. Awards: "Embrace Teamwork Awards" (2010) because of excellent support to cross functional teams "Spot Awards" (twice in 2012; one in 2011) Show less

    • Taiwan
    • Medical Practices
    • 300 - 400 Employee
    • Adjunct attending physician
      • Oct 2001 - Jun 2011

      The main job was to teach medical students who was running their ENT course, educate them on the basics of ENT practice skills and common diseases The main job was to teach medical students who was running their ENT course, educate them on the basics of ENT practice skills and common diseases

    • Taiwan
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Attending Physician. Dep. of Otolaryngology- Head & Neck Surgery
      • Jul 2001 - Nov 2009

      Specialize in diagnosis and management of head 'n neck cancer. Experienced hands in management of sinonasal diseases and snoring & obstructive sleep apnea. Diagnosis and treatment of common ENT diseases. Awards: Best Teacher for Residents 2009 Best Teacher for Interns, 2007 & 2009 Recognition: Recommended Good ENT doctor elected by "Business Weekly" in 2009 Specialize in diagnosis and management of head 'n neck cancer. Experienced hands in management of sinonasal diseases and snoring & obstructive sleep apnea. Diagnosis and treatment of common ENT diseases. Awards: Best Teacher for Residents 2009 Best Teacher for Interns, 2007 & 2009 Recognition: Recommended Good ENT doctor elected by "Business Weekly" in 2009

Education

  • National Taiwan University
    Master, Public Health
    1995 - 1997
  • National Taiwan University
    M.D., Medicine
    1988 - 1995

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