Japan Development Lead, Development TA (General Medicine)

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

.