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Senior Regional Medical Advisor Hong Kong,  

Amgen (company)


Posted on : 22 October 2017

Project Description

Senior Regional Medical Advisor: Cardiovascular-Metabolic-Neurosciences
Purpose
"To provide support to the Regional Medical Affairs in areas of Strategy and deployment of effective Tactics across Cardiovascular, Metabolic and Neurosciences therapy areas.
"To support the Regional Therapy Area Director for effective regional leadership and representation in Global and regional governance boards /management teams.
Key Activities
Goal and strategy:
1.Ensure that archetype and non-archetype country needs are appropriately balanced and reflected in regional and global development and medical planning
2.Work closely with the Regional TA Director towards cross-regional coordination of Development and Medical, identify synergies and efficiencies for Affiliate Development and Medical functions
3.Support region-level portfolio level risk assessments and prioritization of programs
Advance pipeline and TA plan:
Provide support to the Regional TA Director to-
1.Develop and finalize regional evidence generation plan in close collaboration with local TA leads, and ensure alignment across the portfolio
2.Serve as a member to regional brand teams for developing and finalizing regional brand strategy
3.Serve as an interface to communicate regional TA plan/report to Global or regional governance boards (FSC/PG/RPT etc.), and management teams.
4.As a deputy of regional medical lead to sign off Affiliate/Regional protocols and SAP s for local Amgen-Sponsored Trials (ASTs) and Investigator-Sponsored Studies (ISSs) according to Amgen SOPs
5.Chair Regional TA Network meeting
6.Foster and improve International collaboration and coordination
Budget and performance:
Provide support to the Regional TA Director to-
1.Set Regional TA goals to evaluate performance
2.Ensure adequate resources and budget across all regional programs (study and non-study) and maintain budget accountability
Others:
1.Support creation of affiliate TA plans, goals, proposals and deliverables (especially for the affiliate who does not have a local TA lead position)
2.Assist the GDL or local TA lead in identifying and resolving regional/local clinical/scientific issues
Qualifications
"Medical Degree (MD) with specialist qualification and experience in the relevant TA
Experience
"Minimally 8 years of clinical development and medical affairs experience in a TA relevant to the position, 5 years of which should be from a pharmaceutical or biotechnology company
"Broad, direct and matrix leadership 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 and non-interventional studies
"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), EMEA 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, multi-national matrix environment
"Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
"Demonstrated ability to organize and lead expert Clinical Research Advisory Panels
"History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Locations

China, Hong Kong

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