Executive Director, Head of Japac Development

**HOW MIGHT YOU DEFY IMAGINATION?**
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can tun the tide of serious, life-interrupting illnesses.
**Executive Director, Head of JAPAC Development**
**Live**
**What will you do?**
Let's do this. Let's change the world. In this vital role you will report to the VP, Global Development, Oncology TA Head, (RDQ) and oversee a team of approximately 40 colleagues (direct and in-direct). The Executive Director, Head of JAPAC development leads and provides proactive end to end quality strategies globally for therapeutic areas: Oncology, Inflammation, Cardiovascular, Neuroscience and others.
This role builds collaborative supportive relationships and serves as single point of accountably representing RDQ with the Amgen clinical, clinical operations, regulatory and other relevant stakeholders in Research and Development (R&D) and Operations Quality in support of the therapeutic area for which they are responsible.
**Responsibilities**
- Manage the Japan and Asia-Pacific (JAPAC) development team, reporting directly to the Global Development Therapeutic Area
- Provide leadership and strategic guidance to the clinical development teams in China and Japan
- Provide oversight and direction to development activities in JAPAC
- Work closely with Global Development TAs, regional and country medical leadership to develop communications strategies to enhance collaboration between JAPAC and Global Development teams
- Integrate JAPAC region development prioritization across therapeutic areas into Global Teams
- Work in partnership with Global Site Operations (GSO) in ensuring that all clinical trial activities in the region comply with the highest quality and ethical standards and that strict confidentiality is maintained
- Design a development strategic plan for the region in line with the overall strategy defined by Global R&D, region and country
- Gain approval of JAPAC Development strategy plan from the relevant Amgen governance bodies regionally (CC) and globally
- Accountable for JAPAC-specific regulatory correspondence and protocols (in line with the defined global clinical-regulatory strategy)
- Oversee the interpretation and critical evaluation of study results and ensuring reporting of results from the clinical studies (including presenting results in scientific meetings or congresses)
- Build an effective network with internal and external teams (opinion leaders, investigators and relevant agencies)
- Build JAPAC development organizations to desired future capabilities - taking accountability for selected regional studies, regional study conduct in global studies and JAPAC regulatory correspondence and findings, dependent upon program and molecule
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The JAPAC development professional we seek is a Leader with these qualifications.
**Basic Qualifications**:
- Medical or DO degree from an accredited medical school AND
- Five years of industry experience AND
- 6 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources
**Preferred Qualifications**:
- Board certified MD or DO
- Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- Previous management experience
- In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
- Medical Knowledge in Oncology
- Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Understanding of new drug commercialization and business practices
- Understanding of resourcing and budgeting
- Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and w