Auto req 13453BR
Job Posting Title Medical Development Sr Mgr
Career Category Medical Affairs
Employee Subgroup Salaried FT
Country (State/Region) United Kingdom
Location (City) Cambridge
Amgen Job Description Overview:
The Oncology TA lead leads a high-performing office and field-based team, providing medical expertise across the organization to generate strategies, clinical data, analysis and communications that support the safe and effective use of our medicines by patients, physicians and payers .
Key responsibilities
• Set UK/Ireland goals and dashboards to evaluate performance, approving TA plans, goals, proposals and deliverables
• Be the single point of accountability for all UK/Ireland TA activities ensuring alignment of early-stage strategy with late-stage TA objectives
• Drive the data generation, establishing and communicating the strategy for the UK/Ireland TA
• Manage resources, budgets and forecast accuracy within area of responsibility ensuring adequate resources and budget across all programs (study and non-study) and maintain budget accountability.
• Assist the Medical Lead in identifying and resolving clinical/scientific issues and direct UK/Ireland Medical Advisors in navigating products through internal governance and external regulatory portals
• Assist UK/Ireland Medical Advisors in interactions and communication with external customers, key organizations, and institutions
• Assess risk and identifying issues, conflicts or gaps (Affiliate/Sub-Regional) across the portfolio
• Perform portfolio level risk assessments and prioritization of programs
• Chair Affiliate/Sub-Regional TA Team meeting and the Local Development Team (LDT)
• Serve as a key interface to communicate Internationally and locally important issues and status of programs to Amgen IRD and UK/Ireland Management
• Foster and improve International collaboration and coordination
• Partner with the UK/Ireland Business Unit for all product lifecycle management activities
• Provide input, review, approve the UK/Ireland lifecycle management plan and ensure alignment across the portfolio
• Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio
• Provide clinical oversight of product safety evaluation within the Affiliate/Sub-Regional TA
• Provide support and leadership for advisory boards
Basic Qualifications • Medical Degree (MD)
• Extensive experience in designing and managing clinical trials across different phases of development, in providing advice to Medical Advisor within country/ region and resolving clinical trial-related issues
• Substantial experience gained in a pharmaceutical or biotechnology company
• Broad and formal leadership experience
Preferred Qualifications • 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 Medical Advisory Panels
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Track record in effectively managing risk and compliance
• Building strong relationships with KOLs within DA
• Coaching and mentoring Medical Advisor within a Medical Department
• Extensive experience working in cross-functional teams
Competencies:
• Decision Making
• Leadership (Scientific, Technical and Departmental)
• Problem Solving
• Written and Oral Communication
• Innovation
• Initiative
• Delivery Focus
• Conflict management
• KOL engagement
