Sr Medical Advisor Full Time

England - Cambridge, United Kingdom | Professional Qualification | 10 - 15 years | Full Time | Male or Female | Medical Devices | Biotechnology

Job Summary

The jobholder will provide state-of-the-art medical insight into the therapeutic area (TA) of General Medicine and/or specific pipeline molecules serving as the single point of medical contact for the TA for the local Sub-Regional and International teams
He/she will contribute to a high-performing office and field-based team, providing medical expertise across the organization to generate tactics, clinical data, analysis and communications that support the safe and effective use of our medicines by patients, physicians and payers .

Job Responsibilites

• Works with Local and global study management to ensure preparation, implementation and completion of Amgen sponsored studies (AST’s), as per the single medical platform concept
• Works with health economics and Corp. Affairs Depts to ensure market access of products of his/her responsibility in the corresponding TA’s, engaging key stakeholders and payers, and contributing in value dossiers and other access/HE documentation 
• Develops study protocols and data analysis plans for Local AST’s; supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies
• Participates in the development of International strategies and tactics in close collaboration with the IML
• Visits selected opinion leaders (OL’s) and study groups for strategic discussions and protocol development
• Reviews Local/Sub-Regional ISS proposals prior to approval and ensures appropriate Local review prior to IPRC submission, if applicable
• Partners with the Product Manager in the development and execution of the Local/Sub-Regional product(s) lifecycle management plan
• Provides input into site selection for AST’s 
• Oversees in-sourced/outsourced Medical programs and logistics
• Supports Local/Sub-Regional regulatory and ethics approvals for development protocols 
• Develops and executes better recruitment strategies in conjunction with Local GCSM team
• Participates in/conducts Local /Sub-Regional Advisory Board Meetings, Investigator Meetings and/or Expert Panels
• Provides Medical expertise for pipeline products
• Provides Medical expertise for Health Economy and reimbursement requests
• Member of the Local/Sub- Regional Product Teams 
• Delivers TA and/or product specific Medical training 
• Delivers medical expertise for review of promotional and non promotional materials

Job Requirements

Basic Qualifications

• Medical Degree (MD) and full GMC registration
• 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
• Prior experience gained in a pharmaceutical or biotechnology company

Preferred Qualifications

• Medical education or deep scientific expertise in relevant therapeutic area-Bone or Nephrology

• Substantial experience pharmaceutical industry, or proven industry collaboration in academia
• Experience in promotional material sign off in accordance with ABPI reulations 
• Experience in affiliate Medical Department or Clinical Development
• Experience with clinical study management and conduct
• Knowledge of commercialization and business practices


• 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


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

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