Career Category

Clinical Development

Job Description

Accountabilities

As an authority of clinical medicine and science in the JAPAC region:

•Accountable for clinical development activities in JAPAC•Defines JAPAC development strategy across therapeutic areas, together with Global TA Heads, Global Research and JAPAC Medical•Develops communication strategy between JAPAC and Global TAs/GDLs•Provide oversight of organizational deliverables in the region

Responsibilities

•Provides oversight and direction to development activities in JAPAC•Works closely with Global Development TAs and develops communications strategies to enhance collaboration between JAPAC and Global Development teams•Works closely with regional and country medical leadership•Integrates JAPAC region development prioritization across therapeutic areas into Global Teams •Works 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•Designs a development strategic plan for the region in line with the overall strategy defined by Global R&D, region and country •Gains 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)•Provides leadership to the clinical development teams in China and Japan•Oversees 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)•Builds an effective network with internal and external teams (opinion leaders, investigators and relevant agencies)•Builds 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

Basic Qualifications

• Medical Doctor or Ph.D.

• Five (5) or more years of clinical research experience and/or basic science research experience

• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

Preferred Qualifications

• MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent

• 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

Knowledge

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

• 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

•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

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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