Career Category
ClinicalJob Description
Purposes 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 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 JCDP are based on multifaceted considerations aiming to maximize values for patients and Amgen
- Provide local medical/clinical input on treatment paradigms, guidelines, unmet needs 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
- Support 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, 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 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
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