잡스
>
Seoul

    Clinical Research Senior Manager - Seoul, 대한민국. - Amgen

    Amgen
    Amgen Seoul, 대한민국.

    4일 전

    Default job background
    Paid Work
    설명

    Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6

    We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

    Accountabilities

    • To serve as local development lead for phase I-III clinical development of Amgen Pipelines in oncology and general medicine
    • To contribute to define, design, and execute clinical development as a strategy for drug development in Korea.
    • To serve as key role in external collaboration and strategic partnership with key local sites in clinical studies and related research area
    • To represent Medical Sciences internally and externally, contributing local medical insight into experimental design and data analysis.
    • To provide subject matter expertise in clinical and translational trial science as well as the biology and treatment.

    Responsibilities:

    • Lead and/or contribute to designing, gaining approval of and executing high quality development strategy for assets in Korea, collaborating with cross-function local colleagues and global partners, together with key functional stakeholders and governance bodies
    • Support the development and execution for clinical trials in Korea and be the local/regional medical science expert in resolving significant issues that may affect the studies
    • Work closely with local/regional/global cross functional colleagues, including Clinical Operations, Patient Safety and Regulatory counterparts, to provide medical expertise to the study team
    • Share local/regional clinical/scientific input during the development and execution of clinical trials
    • In defined situations working under the Global Development Lead to :
    • Contribute or lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP).
    • Serve as a member of the CST-LT, provide medical and strategic oversight to the study execution.
    • Monitor, analyse, and interpret clinical study data
    • Contribute to the preparation of documents required for regulatory submissions
    • Develop and interface with local/regional industry key opinion leaders and manage scientific presentation at advisory boards, key scientific meetings and external committee meetings
    • Participate in interactions with regulatory agencies
    • Support the local/regional Brand Team in the brand planning process to ensure alignment between medical and brand activities, and help providing interpretation of clinical study data
    • Ensuring compliance with GCP across clinical trials

    Output

    • Ensure local/regional/global clinical studies are adequately and timely supported and executed
    • Ensure medical support leading to successfully submission and approval of CTNs and MAAs
    • Establish and maintain appropriate relationship with local/regional industry key opinion leaders and medical communities

    Skills and Qualities

    • MD degree from an accredited medical school, and experience in patient care required
    • Minimum 78 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company)
    • Demonstrate in-depth knowledge in therapeutic areas of oncology, hematology and/or general medicine
    • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
    • Familiarity with concepts of clinical research and clinical trial design, including working knowledge of statistics as applied to clinical trial design and analysis
    • Previous experience in early and/or late-stage oncology clinical trials and regulatory filings
    • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
    • Experience in writing and editing scientific research reports
    • Thorough understanding of GCP and familiarity with relevant NMPA and ICH guidance
    • Ability to collaborate effectively in and/or lead cross-functional teams
    • Strong commitment to goals and timelines
    • Ability to absorb new information quickly and gain command of relevant literature
    • Possessing excellent problem-solving & decision-making skills
    • Excellent written and verbal communication skills, including fluency in English

  • Coupang

    Senior Manager, Program Management

    1주 전

    Coupang Seoul, 대한민국.

    회사 소개 · 쿠팡은 고객 감동 실현을 위해 존재합니다. 고객들이 "쿠팡 없이 그동안 어떻게 살았을까?" 라고 말할 때, 비로소 우리의 미션을 실현하고 있음을 알 수 있습니다. 고객들의 쇼핑과 식사, 생활 전반을 편하게 만들겠다는 유일한 집념으로 쿠팡은 수억 달러 규모의 이커머스 산업 전반의 혁신을 이끌고 있습니다. 쿠팡은 가장 빠르게 성장하는 이커머스 기업 중 하나로, 국내 커머스 업계에서의 독보적인 입지와, 고객 신뢰를 구축했습니다. · 쿠팡은 스타트업 문화를 기반으로 한 글로벌 대형 상장사라 ...

  • Coupang

    Senior Product Manager

    4일 전

    Coupang Seoul, 대한민국.

    회사 소개 · 쿠팡은 고객 감동 실현을 위해 존재합니다. 고객들이 "쿠팡 없이 그동안 어떻게 살았을까?" 라고 말할 때, 비로소 우리의 미션을 실현하고 있음을 알 수 있습니다. 고객들의 쇼핑과 식 사, 생활 전반을 편하게 만들겠다는 유일한 집념으로 쿠팡은 수억 달러 규모의 이커머스 산 업 전반의 혁신을 이끌고 있습니다. 쿠팡은 가장 빠르게 성장하는 이커머스 기업 중 하나로, 국내 커머스 업계에서의 독보적인 입지와, 고객 신뢰를 구축했습니다. · 쿠팡은 스타트업 문화를 기반으로 한 글로벌 대형 상장 ...

  • Coupang

    Eats Senior Manager, Program Management

    2주 전

    Coupang Seoul, 대한민국.

    [조직소개] · Data Management 팀은 다양한 채널을 통하여 Internal / External 데이터를 수집하고 가장 효율적인 방법으로 데이터를 관리, 정제하여 액션 아이템에 필요한 자료를 stakeholder에게 제공하는 업무를 맡고 있습니다. 이 과정을 수행하기 위해, Biz Ops team, Data Scientist, 그리고 Data engineering등의 부서와 협업하여 최적의 데이터 수집관리 솔루션을 구축해야 하며 이를 통해, CX관점에서 가장 Aim-high된 Merch ...

  • Lunit

    Senior Government Project Manager

    1주 전

    Lunit Seoul, 대한민국. 풀타임

    Conquering cancer through AI" · Lunit은 "Learning Unit"을 줄여 만든 이름으로, · 암 진단 및 치료에 기여하는 인공지능 솔루션을 개발하고 제공하는 의료 AI 기업입니다. · 루닛은 인공지능 기술을 통해 더 정확한 암 진단과 치료 효과 예측이 가능해지고, · 환자를 위한 신속한 맞춤형 치료가 가능해지는 시대를 열고자 합니다. · About the team · Market Access & Strategy team은 인공지능(AI) 의료기술이 국가와 시장에서 ...

  • NielsenIQ

    Senior Manager

    3일 전

    NielsenIQ Seoul, 대한민국. 풀타임

    Company Description · We're in tune with what the world is buying. If you can think of it, we're measuring it. We sift through the small stuff and piece together big pictures to provide a comprehensive understanding of what's happening now and what's coming next for our clients. ...

  • AIA

    헬스케어 모바일 플랫폼(Vitality) IT Senior Manager

    3일 전

    AIA Seoul, 대한민국. 풀타임

    At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. · If you believe in developing a better tomorrow, read on. · About the Role · [팀/포지션 요약] · 고객플랫폼팀은 AIA생명의 고객 대면 Digital 채널 및 Platform을 구축/운영하며, AIA 생명의 대면 고객 만족도 향상을 목표로 합니다 ...

  • AIG

    Senior Accounting Manager

    6일 전

    AIG Seoul, 대한민국. 풀타임

    Senior Accounting Manager, Finance, South Korea · Who we are · American International Group, Inc. (AIG) is a leading global insurance organization. Building on 100 years of experience, today AIG member companies provide a wide range of property casualty insurance, life insurance, ...

  • Media

    Senior Project Manager

    1주 전

    Media Seoul, 대한민국.

    The Opportunity · We are looking for a Senior Project Manager to offer client support for our Seoul data team. As a Senior Project Manager you will own relationships with stakeholders and various client-side departments to oversee design, development, and utilisation of data f ...

  • Teads

    Senior Sales Manager

    1주 전

    Teads Seoul, 대한민국.

    Who we are · We are a global AdTech company with over 1200 employees across 30 countries with over 100 different nationalities · Competing against the biggest tech companies · Inventor of the InRead Video · Partner with the biggest media agencies and brands · Global partners ...

  • Teads

    Senior Sales Manager

    1주 전

    Teads Seoul, 대한민국.

    Who we are · We are a global AdTech company with over 1200 employees across 30 countries with over 100 different nationalities · Competing against the biggest tech companies · Inventor of the InRead Video · Partner with the biggest media agencies and brands · Global partners ...

  • Elastic

    Senior Partner Manager

    3일 전

    Elastic Seoul, 대한민국. 풀타임

    Job Basics · Elastic is a free and open search company that powers enterprise search, observability, and security solutions built on one technology stack that can be deployed anywhere. From finding documents to monitoring infrastructure to hunting for threats, Elastic makes data ...

  • Novo Nordisk A/S

    Senior Accounting Manager

    2일 전

    Novo Nordisk A/S Seoul, 대한민국.

    Are you a finance professional with strong accounting knowledge? Are you looking for an opportunity to work in a global healthcare company? Novo Nordisk is seeking a Senior Accounting Manager to join our team in South Korea. If you are detail-oriented, have a strong understanding ...

  • AIG

    Senior Accounting Manager

    6일 전

    AIG Seoul, 대한민국. 풀타임

    Senior Accounting Manager, Finance, South Korea · Who we are · American International Group, Inc. (AIG) is a leading global insurance organization. Building on 100 years of experience, today AIG member companies provide a wide range of property casualty insurance, life insurance, ...

  • Coupang

    Senior Program Manager

    1주 전

    Coupang Seoul, 대한민국.

    Company · We exist to wow our customers. We know we're doing the right thing when we hear our customers say, "How did we ever live without Coupang?" Born out of an obsession to make shopping, eating, and living easier than ever, we're collectively disrupting the multi-billion-dol ...

  • Novo Nordisk

    Senior Accounting Manager

    17시간 전

    Novo Nordisk Seoul, 대한민국.

    Are you a finance professional with strong accounting knowledge? Are you looking for an opportunity to work in a global healthcare company? Novo Nordisk is seeking a Senior Accounting Manager to join our team in South Korea. If you are detail-oriented, have a strong understanding ...

  • Media

    Senior Account Manager

    6일 전

    Media Seoul, 대한민국.

    The Role: · As a consultative partner, the Senior Account Manager will advise Media.Monk's clients on industry trends and ways to harness different technology solutions to drive long-term value. Successful candidates for this opportunity will demonstrate strategic thought and c ...

  • AIG

    Senior Accounting Manager

    5일 전

    AIG Seoul, 대한민국. Paid Work

    Senior Accounting Manager, Finance, South Korea · Who we are · American International Group, Inc. (AIG) is a leading global insurance organization. Building on 100 years of experience, today AIG member companies provide a wide range of property casualty insurance, life insuranc ...

  • Coupang

    Senior Product Manager

    2주 전

    Coupang Seoul, 대한민국.

    Senior Product Manager (Marketplace Product) · Description · We exist to wow our customers. We know we're fulfilling our mission when we hear our customers say, "How did we ever live without Coupang?" Born out of an obsession to make shopping, eating, and living easier than ever, ...

  • MetrixLab

    Senior Research Manager

    1주 전

    MetrixLab Seoul, 대한민국.

    About us: · MetrixLab is a fast-growing global market research and insights company that's challenging the status quo of insights. By blending evolving technology with passionate experts, MetrixLab helps global and local brands to drive more impact, and forges partnerships to d ...

  • Beam

    Senior Operations Manager

    1주 전

    Beam 서울특별시, 대한민국. 풀타임

    Beam is Asia Pacific's largest shared micromobility company, we are on a mission to turn little drives into better rides and make cities flow better for everyone. · Shared micromobility is one of the fastest-growing industries in the world, and we're leading the way in Asia Pacif ...