Medical Head, Saudi Arabia (KSA) - Amgen

Category: Medical Affairs
Job ID: R-103015
Location: Riyadh, , SA
Additional Location:
Posted Date: 8/12/2020

Medical Head – Saudi Arabia

Reporting into the Medical Director for Middle East Africa (Sub Region)

Responsibilities

• Provide strategic insight, and contribute to patient-focused medical strategies that maximize the value proposition of Amgen's therapies including annual strategic planning and goal setting, launch support and lifecycle management, in collaboration with appropriate cross-functional teams and governance, ensuring alignment across Saudi Arabia
• Partner with cross functional stakeholders to shape the healthcare ecosystem by enabling access through evidence generation, communication and education of medical and economic value
• Provide strategic input into key, high-impact insights and ensure robust staff competency
• Foster and enhance collaboration and coordination across Medical
• Set the strategy for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product
• Lead relationships with external healthcare community, including interactions with opinion leaders, payers, societies and industry associations for scientific exchange, as Amgen's top Saudi Arabia medical representative
• Drive Saudi Arabia strategy, adherence to governance, development, prioritization and performance of evidence generation portfolio
• Foster Amgen‘s reputation as a science-based and patient-focused reliable partner
• Provide strategic input into development of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate
• Partner with Global Regulatory Affairs and Safety (GRAAS) in risk management/minimization activities, ensure human subject safety in partnership with responsible functions (ie., Global Regulatory Affairs and Safety, Global Development), and ensure communication of the implications to internal/external stakeholders, serve as Saudi Arabia escalation for safety/quality issues and provide clinical oversight of product safety evaluation at the Saudi Arabia level
• Develop and manage medical budget and resources
• Recruit, retain, coach, mentor, motivate and develop talent
• Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
• Ensure appropriate medical staff training
• Accountable for appropriate clinical trial conduct across the region (i.e., overseeing clinical trial priorities, ensure goals are met, including site recruitment and subject enrollment predictability) with direct oversight for, and close partnership with Development Operations (Site Management)
• Provide strategic input into labels/regulatory/reimbursement/policy/promotional and medical deliverables used to support internal/external interactions
• Determine scientific / medical subject matter appropriateness of labels / regulatory / reimbursement / policy / promotional and medical deliverables (i.e., slide decks, publications, educational activities) used to support internal/external interactions via appropriate review process
• Provide strategic input into medical communications deliverables (i.e., product narrative, scientific platform, core content, publications, medical education and congresses)
• Provide oversight or guidance and approve portfolio level risk assessments and prioritization of medical programs at Saudi Arabia level
• Provide strategic input into data interpretation and analysis, as appropriate
• Provide decision on IME, Donations, medical grants and sponsorships, where appropriate
• Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement
• Understand the expectations of key external stakeholders to support appropriate access to Amgen therapies
• In partnership with cross-functional leadership team, ensure informed budget/resource trade-offs
• Develop and execute Medical staff engagement plan
• Direct medical teams in navigating products through internal governance and external regulatory interactions as appropriate
• Ensure scientific/clinical oversight for due diligence in partnership with Business Development and ensure support for partner relationships, as appropriate
• Drive the Evidence Generation plans, from ideation to cross functional validation as also guaranteeing proper execution, always aligned with therapeutic area priorities.
• Be the voice of the patient in the affiliate.,

Minimum Requirements

• Doctor of Medicine (MD) or equivalent
• 4 years of medical affairs or clinical development experience, 2 years of which should be from a pharmaceutical or biotechnology company
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Broad and formal leadership experience
• International and/or Global experience

Preferred Requirements

• Accredited fellowship in respective product, board certified or board eligible
• Demonstrated ability as a medical expert in a complex matrix environment
• Pharmaceutical product development, product life cycle and commercialization process knowledge/proven experience with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs
• Therapeutic area knowledge
• Expertise in regional/local medical practice and healthcare ecosystems
• Skilled at engagement, scientific exchange with external medical community
• Clinical research experience
• 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
• Sound scientific and clinical judgement
• Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements
• Deep Knowledge of local pharmaceutical industry and legal/health system environment
• Finance/budgeting and resource management experience
• Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment
• Skilled at effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Network of medical, clinical contacts

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