Career Category Medical Affairs Job Description Job purpose Lead and develop product medical strategy and plan based on product strategy for assigned product(s), including pipeline or pre-launch product(s). Act as a key Medical member in the cross-functional product team to develop and execute product strategy with cross-functional members, as well as Global/Regional Medical teams. Provide Japan position on global/region disease and product related programs. Provide medical affair consideration on portfolio evaluation and discussion. Lead the planning and execution of evidence generations, publications and medical events. Key responsibility Partners with the brand team in the development and execution of the Local product(s) medical strategy and launch readiness plan. Leading and developing the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations TA and/or product specific Medical training Ensuring consistency of Medical content and scientific messages across various tools and materials Engages external experts and stakeholders for scientific discussions, insight generation. Develops study protocols for Local Amgen sponsored studies (AST); supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies Works with Global Study Operations (GSO) to ensure preparation, implementation and completion of ASTs Supports GSO in participation and completion of global/region studies in the country, including provision of input into site selection Oversees in-sourced/out-sourced medical programs and logistics , including vendor and timeline management. Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels Provides Medical expertise for Health Economy and reimbursement requests Proactively prioritizes and drives medical activities in alignment with cross-functional stakeholders in a complex and evolving environment. Basic
Qualifications
Selection Criteria (minimum Qualifications) Master’s degree in life-science or relevant area, equivalent education history Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia
Experience
in Medical Department or Clinical Development
Experience
with clinical study management and conduct Knowledge of commercialization and business practices Fluent in Japanese and English
Preferred Qualifications
Preferred
Requirements
MD, PharmD or PhD is strongly preferred Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs Therapeutic area knowledge and experience is preferable Scientific network with external experts in therapeutic area, or ability to build such network.
Experience
in pre-launch planning, launch readiness, or pipeline product strategy is preferred. Finance and budgeting experience Project management skills. Competencies Medical/scientific expertise, and business acumen with strategic thinking. Fluency in English, both oral and written communications Strong communication and presentation skills Continuously expanding medical and scientific knowledge as well as market knowledge Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, external expert engagement.) Strong customer orientation; science-based Ability to work in a cross-functional team (e.g., Commercial, Clin Development, Global/Regional teams, Value & Access, Regulatory, Safety, etc.) Ability to work proactively, set priorities, and drive execution in collaboration with relevant stakeholders. Role model for others in line with Amgen Values Demonstrates leadership skills . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen