Therapeutic Area Medical Sr Mgr

Role Overview

Therapeutic Area Medical Senior Manager at Amgen. This is a Medical Affairs role responsible for serving as a point of medical contact for allocated product(s) and leading adaptation of global and regional strategy to reflect local and regional priorities.

Company Overview

Amgen is one of the world's leading biotechnology companies, reaching over 10 million patients worldwide, driven by a shared mission to serve patients.

Role Purpose

Lead medical strategy development and execution for allocated product(s), synthesizing scientific insights and external stakeholder engagement to maximize Amgen's value proposition of inline and pipeline products while fostering the company's reputation as a science-based, innovative, and patient-focused partner.

Key Responsibilities

Strategy & Planning

• Support development and execution of 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 Medical Product Lead and Medical Therapeutic Area Head.
• Synthesize and integrate insights to deliver medical inputs into relevant cross-regional and cross-functional strategies, including relevant brand strategy.
• Contribute to strategy development for scientific engagement across a broad range of stakeholders to strengthen external understanding of unmet need and value of the product.
• Develop strategy for medical evidence generation that shapes products and informs the practice of medicine, ensuring key needs are met in alignment with global product medical strategy and relevant brand strategy.
• Contribute to lifecycle management plan.
• Provide strategic input into labels, regulatory, reimbursement, policy and promotional materials used to support internal and external interactions.

Stakeholder Engagement & Collaboration

• Contribute to cross-functional stakeholder teams in shaping the healthcare ecosystem by enabling access to medicines through evidence generation, communication and education of medical and economic value.
• Foster and enhance collaboration and coordination across Medical.
• Lead and support relationships with external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange, where appropriate.
• Understand the expectations of key external stakeholders to support appropriate access to Amgen therapies.
• Provide support and leadership of advisory boards and other relevant meetings, including investigator meetings and expert panels.
• Partner with Global Regulatory Affairs and Safety in risk management and minimization activities and ensure communication of implications to internal and external stakeholders.

Medical Evidence & Communications

• Develop and support execution of the strategy for medical evidence generation.
• Lead and support development of data interpretation, analysis and communication for medical-executed studies.
• Contribute to strategy development for, review, approve and ensure dissemination of medical communications and related activities, including product narrative, scientific platform, core content, publications (FPR/FLR), medical education and congresses.
• Determine scientific and medical subject matter appropriateness of labels, regulatory, reimbursement, policy, promotional and medical deliverables via appropriate review process.
• Facilitate Investigator Sponsored Studies through Amgen governance and manage study lifecycle, including communicating with investigators and ensuring accurate reporting of key milestone data.

Advocacy & Grants

• Develop and contribute to execution of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate.
• Provide decision on Investigator Meetings and Exchanges (IME), donations, medical grants and sponsorships, where appropriate.

Compliance & Regulatory

• Ensure conduct of medical activities in full compliance with all laws, regulations and standard operating procedures.
• Ensure appropriate clinical trial conduct as a key medical interface in close partnership with Global Development Operations.
• Provide product, disease state and pipeline-specific medical training where appropriate and may deliver training to others.

Governance & Reporting

• Serve as member and medical representative of relevant leadership, governance and cross-functional teams.
• Foster Amgen's reputation as a science-based, innovative and patient-focused reliable partner.
• Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement.

Budget & Resources

• May develop and manage medical product budget.
• In partnership with cross-functional team, ensure informed budget and resource trade-offs as appropriate.

Team Leadership & Development

• Recruit, retain, coach, mentor, motivate and develop talent as appropriate.

Qualifications & Experience

Minimum Requirements

• Doctorate degree.
• 5 years of medical affairs or clinical development experience and education in relevant therapeutic area, with 1 or more years 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.

Preferred Requirements

• Doctor of Medicine (MD).
• Demonstrated ability as a medical expert in a complex matrix environment.
• Pharmaceutical product development, product lifecycle and commercialization process knowledge with understanding of other functions, including Clinical Operations, Commercial, Safety, Regulatory, Value & Access and Medical Affairs.
• Product and therapeutic area knowledge.
• Experience in regional and local medical practice and healthcare ecosystems.
• Skilled at engagement and 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.
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics.
• Sound scientific and clinical judgment.
• Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements.
• Familiarity with local pharmaceutical industry and legal and 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 and 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 and clinical contacts in product and therapeutic area.

Skills & Competencies

Scientific and Technical Expertise

• Understanding of external landscape impacting Amgen products.
• Deep knowledge of relevant Amgen assets, disease state and medical specialties.
• Medical Affairs expert.
• Deep and broad understanding of evidence generation process.
• Knowledge of compliance, safety and regulatory within locale.
• Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions, including Global Development, Commercial, Safety and Regulatory.
• Strong analytical skills.
• Deep understanding of reimbursement, access and payer environment.

Business Acumen

• Deep awareness of objectives, goals, challenges and financial constraints and understanding the need to measure performance and adopt a continuous improvement mentality.
• Corporate maturity and savvy.
• Strategic thinking, including ability to form and convey strategic insights, analyze problems and make decisions.
• Take appropriate risks.
• Understanding of global context and ability to translate across geographies.
• Deep understanding of brand strategy.
• Operational excellence: management skills, planning, prioritization, decision making, objective setting, meeting management and plan execution.
• Skilled at leveraging medical content and appropriately shaping to inform and guide communication with external medical community.

Creating a Collaborative and Enabling Climate

• Establish an enabling environment as a role model of Amgen's Values, Leadership Attributes and Operating Model behaviors.
• Enable engagement and self-motivation of others.
• Build, manage and lead high-performing teams and individuals.
• Provide support for career path and career development.
• Empower appropriate risk taking and decision making.
• Recruit, retain, coach, mentor, motivate and develop talent.
• Ability to effectively lead through change.

Agility and Learning

• Embrace change and ambiguity.
• Foster a culture of innovative thinking.
• Lead and support innovation.
• Demonstrate judgment informed by experience.
• Foster appropriate risk tolerance.
• Forecast and pivot.
• Strong commitment to ongoing learning and professional capability enhancement.

Influencing, Integrating and Facilitating

• Shape vision and strategy.
• Focus with 360-degree perspective, including internal and external stakeholders.
• Ensure representation of the patient perspective and voice of patient.
• Optimize leadership styles.
• Build and cultivate relationships.
• Excellent communication and presentation skills.
• Strong cross-functional negotiation skills and ability to skillfully navigate the executive matrix.

Additional Information

The assignment of Global Compensation Framework (GCF) Level for this discipline requires a role assessment with Human Resources. The assessment will evaluate the overall scope and organizational impact of the role, including but not limited to the size and complexity of the applicable local market(s), product(s) and pipeline portfolio. Contact your HR Business Partner to initiate this assessment.

In addition to base salary, Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards.

Amgen is an Equal Opportunity employer and will consider applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Amgen will