Career Category

Job Description

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.

We are currently looking for a Therapeutic Area Lead to drive the Onco-hematology medical affairs strategy in Iberia. This role is based in Barcelona.

Responsibilities

• Being the single point of accountability for all Affiliate TA activities
• Driving the data generation, establishing and communicating the strategy for the Affiliate Sub-Regional TA
• Developing goals and tactics for the Affiliate TA
• Managing resources and budget for the Affiliate TA; forecast accuracy within area of responsibility
• Directing Affiliate Medical Advisors in navigating products through internal governance and external regulatory portals
• Assisting Affiliate Medical Advisors in interactions and communication with external customers, key organizations, and institutions
• Assessing risk and identifying issues, conflicts or gaps (Affiliate) across the portfolio
• Hiring, coaching, mentoring and developing staff and team members
• Ensuring Affiliate TA goal accountability
• Provide leadership and strategic direction to the Affiliate TA staff
• Assist the IML in identifying and resolving clinical/scientific issues
• Perform portfolio level risk assessments and prioritization of programs
• Ensure alignment of early-stage strategy with late-stage TA objectives
• Approve Affiliate TA plans, goals, proposals and deliverables, including but not limited to protocols and SAP’s for local AST’s
• Chairs Affiliate TA Team meeting
• Foster and improve International collaboration and coordination
• Serve as a key interface to communicate Internationally and Locally important issues and status of programs to Amgen IRD and Affiliate Management
• Partner with the Affiliate Business Unit for all product lifecycle management activities
• Provide input, review, approve the Affiliate lifecycle management plan and ensure alignment across the portfolio
• Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio
• Chairs the Local Development Team (LDT)
• Member of the International Development Team (IDT)
• Member of the International Business Team (IBT)
• Provide clinical oversight of product safety evaluation within the Affiliate TA
• Provide support and leadership for advisory boards
• Set Affiliate TA goals and dashboards to evaluate performance
• Ensure adequate resources and budget across all programs (study and non-study) and maintain budget accountability

Minimum Requirements

• 6 or more years of clinical development experience, 4 years of which should be from a pharmaceutical or biotechnology company
• Clinical research experience
• Broad and formal leadership experience

Preferred Requirements

• Onco-hematology expertise highly recommended
• 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), 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