Career Category

Job Description

Accountabilities

Responsibilities

Local product(s) life cycle management

• Partners with the BU in the development and execution of the Local product(s) lifecycle management plan
• Co-leads the brand meetings with the Product Manager
• Leads and develops the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations
• Participates in the development of International strategies and tactics in close collaboration with the IML
• Reviews Local ISS proposals prior to approval and ensures appropriate Local review prior to IPRC submission, if applicable
• Oversees in-sourced/outsourced Medical programs and logistics

Development and management of the medical plan

• Identifies local data gaps, medical needs, study/research planning
• Aligns the local medical plan with the local commercial plan and the global medical plan

Provides medical expertise to internal and external stakeholders

• Provides TA and/or product specific Medical training
• Manages internal and external relationships within area of responsibility
• Ensures consistency of Medical content and scientific messages across various tools and materials
• Participates in/conducts National Advisory Board Meetings, Investigator Meetings and/or Expert Panels
• Provides Medical expertise for pipeline products/Health Economy and reimbursement requests
• Approves scientific content of Local symposia/workshops/publications/promotional materials/medical section of reimbursement files

Clinical study support

• Provides input into site selection for AST’s
• Works with Local DFO to ensure preparation, implementation and completion of AST’s (Amgen sponsored studies)
• Supports Local regulatory and ethics approvals for development protocols
• Develops and executes better recruitment strategies in conjunction with Local DFO team
• Develops study protocols and data analysis plans for Local  AST’s and LOSs supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies
• Coordinates LOSs (Local Observational Studies)
• Supports Local DFO in participation and completion of International development studies in the country
• Visits selected KOL’s and study groups for strategic discussions and protocol development
• Signs off Direct Outside Expense at signature level

Outputs

• Brand/disease specific parts of Local R&D plan
• Local support for Medical questions, feasibility and trial strategy
• Local Product Lifecycle Plan
• Protocols and other study documents for local AST
• Medical expertise for the review of promotional and scientific documents (e.g. symposia, publications etc.)
• Local R&D brand/disease related results according to goals and metrics

Competencies

• Medical and scientific expertise
• Fluency in Dutch, French and 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, KOL management)
• Strong customer orientation; science-based
• Ability to work in a cross-functional team (e.g., Commercial, Market Access, Clin Development, HE, Regulatory, Safety, etc.)
• Role model for others in line with Amgen Values

Minimum Requirements

• Medical education or deep scientific expertise in relevant therapeutic area
• Fluent in both Dutch, French and English
• Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia

Preferred Requirements

• Experience in affiliate Medical Department or Clinical Development
• Experience with clinical study management and conduct
• Knowledge of commercialization and business practices

Required knowledge and training

• 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
• Network of customer contacts in therapeutic area
• Finance and budgeting experience