Career Category

Job Description

Senior Regional Medical Advisor: Cardiovascular-Metabolic

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 Lead for strategic initiatives and projects, including Medical Education, Publications, Scientific content, Scientific Engagement Plan, Insights Framework, Advisory Boards, Evidence generation and Internal medical capabilities build.

4.Serve as an interface to communicate regional TA plan/report to Global or regional governance boards (FSC/PG/RPT etc.), and management teams.

5.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

6.Chair Regional TA Network meeting

7.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

•Minimum 3-5 years of clinical development and medical affairs experience in a TA relevant to the position, from a pharmaceutical or biotechnology company

•Broad, direct and matrix leadership experience

•Previous experience in cardiovascular in particular heart failure is preferred

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), JAPAC 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

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.