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

.