Japan Development Lead, Development TA (General Medicine)

Job description

Career Category Clinical Job Description Purposes of the job are, Accountable for leading the develop ment and implementation of the Japan Clinical Development Plan (J CDP ) 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 function al members in proceed ing with all clinical activities/deliverables as planned Provide medical/clinical expertise to advance clinical development in Japan Assigned 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 JEGP Responsibilities include, Obtain global CDP for JPST members to adapt them into JCDP; ensure that the J CDP are based on multifaceted considerations aiming to maximize values for patients and Amgen Provide local medical/clinical input on treatment paradigm s , guideline s , unmet need s to the global team in the CDP and study design Partner 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 trials S upport 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 Japan As 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, s upport 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 EGP Encourage active and efficient work styles in accordance with the Team Charter and build an environment where each member can utilize their full potential Delegate/coach/support JDMs and develop their talent if applicable Proactively share lessons & learned and know-how from their project activities and contribute to organizational Kaizen Qualifications Basic Qualifications 5 or more years of clinical development experience in the biopharmaceutical industry , and experience with clinical project lead or proven industry collaboration in academia Proven ability to lead multiple projects/indications and produce high-quality results Medical degree , PhD , and/or equivalent experiences of Master’s degree Fluency in English, both oral and written communications Business Japanese skill, both oral and written communications Preferred Qualifications Experience to manage product life cycle management in collaboration across functions as a lead and/or representative from Clinical Development Experience to manage early phase of clinical trial Experience with NDA filing Knowledge / Experience Understanding of Japanese regulatory agency organization, guidelines, and practices and ability to negotiate with these groups Understanding 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 Policy In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials Medical knowledge in the relevant therapeutic area Sound scientific and clinical judgment Experience in leading Clinical Development and NDA filing Experience with clinical study management and conduct Knowledge of GCP, PMDA regulations, guidelines and compliance Competencies Demonstrates Amgen Values and Leadership Attributes Demonstrates strategic mindset to enable challenging JEGP/JCDP for patients in Japan Demonstrates robust ability to build effective cross functional teams through collaboration Instills trust by following through on commitment and showing consistency between words and actions Be resilient in cross functional collaborations Anticipate the impact of emerging technologies and makes adjustments, in particular, for the strategic clinical planning .