Career CategoryClinicalJob DescriptionPurposes of the job are,Accountable for leading the development and implementation of the Japan Clinical Development Plan (JCDP) which is a part of Japan Evidence Generation Plan (JEGP), incorporating local current medical/clinical insights into specific molecules in accordance with global development strategy (regardless of JPST Lead assignment)Expected to support other functional members in proceeding with all clinical activities/deliverables as plannedProvide medical/clinical expertise to advance clinical development in JapanAssigned with a dual role for Japan Product Strategy Team (JPST) Lead, accountable for leading cross functional team discussions to develop the Japan Product Strategy (JPS) and the JEGPResponsibilities include,Obtain global CDP for JPST members to adapt them into JCDP; ensure that the JCDP are based on multifaceted considerations aiming to maximize values for patients and AmgenProvide local medical/clinical input on treatment paradigms, guidelines, unmet needs to the global team in the CDP and study designPartner with Regulatory Affairs and Safety/ Value & Access (V&A) to define and maintain the product benefit/risk profile and facilitate local registration and reimbursement by providing medical/scientific leadership and input into key regulatory/safety deliverables, such as CTD, Regulatory responses, etc.Partner with Local Development Operations (including project specific cluster team) to provide strategic oversight and execution of clinical trialsSupport Local Development Operations and Local Medical Affairs in clinical study activity (e.g., a speaker at investigator meetings, regulatory inspection, supplemental local training at LST, and co-visit to clinical sites) following GDO-medical collaboration playbook for JapanAs JPST Lead, lead the development of JPS and associated JEGP in aligned with Global Product Strategy (GPS)/ Global Brand Plan (GBP), and obtain endorsement from Japan Portfolio Review Committee (JPRC) following JPST playbook As JPST Lead, support the Local Medical Affairs, Marketing, and V&A in capturing and translating local/regional data gaps into actionable JEGPs, in alignment with GPS/GBP and EGPEncourage active and efficient work styles in accordance with the Team Charter and build an environment where each member can utilize their full potentialDelegate/coach/support JDMs and develop their talent if applicableProactively share lessons & learned and know-how from their project activities and contribute to organizational KaizenQualifications Basic Qualifications5 or more years of clinical development experience in the biopharmaceutical industry, and experience with clinical project lead or proven industry collaboration in academiaProven ability to lead multiple projects/indications and produce high-quality results Medical degree, PhD, and/or equivalent experiences of Master’s degreeFluency in English, both oral and written communicationsBusiness Japanese skill, both oral and written communicationsPreferred QualificationsExperience to manage product life cycle management in collaboration across functions as a lead and/or representative from Clinical DevelopmentExperience to manage early phase of clinical trialExperience with NDA filingKnowledge/ ExperienceUnderstanding of Japanese regulatory agency organization, guidelines, and practices and ability to negotiate with these groupsUnderstanding of new drug product lifecycle and commercialization process with understanding of other functions; including but not limited to Clinical Operations, Commercial, Regulatory, and Medical Affairs, Value Access and PolicyIn-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trialsMedical knowledge in the relevant therapeutic areaSound scientific and clinical judgmentExperience in leading Clinical Development and NDA filingExperience with clinical study management and conductKnowledge of GCP, PMDA regulations, guidelines and complianceCompetenciesDemonstrates Amgen Values and Leadership AttributesDemonstrates strategic mindset to enable challenging JEGP/JCDP for patients in JapanDemonstrates robust ability to build effective cross functional teams through collaborationInstills trust by following through on commitment and showing consistency between words and actionsBe resilient in cross functional collaborationsAnticipate the impact of emerging technologies and makes adjustments, in particular, for the strategic clinical planning.