Career Category

Medical Affairs

Job Description

This role will be pivotal in driving clinical excellence within Therapeutic Area General Medicine with main focus on the Obesity Therapeutic Area. This position emphasizes scientific and medical leadership, focusing on accelerating clinical trials recruitment, ensuring subject retention, engaging with Key Opinion Leaders (KOLs), and supporting the strategic execution of medical programs. This role demands a high level of technical expertise, strategic thinking, and collaboration to drive clinical excellence and support the successful execution of medical strategies and clinical trials.

KEY RESPONSIBILITIES

Clinical Trial Support:

• Collaborate with clinical teams and ensure efficient trial start-up, subject enrollment, retention and execution, particularly in new therapy areas.
• Identify, map and implement local scientific engagement plan, identify and map KOLs, clinical leaders, investigators, and research centers in relevant therapy areas, and engage them in clinical trial activities. (in collaboration with External Engagement and/or local Medical team)
• Provide scientific and medical expertise during site selection, initiation visits, and throughout the trial phases, including study close-out activities.
• Lead discussions with clinical experts to guide trial execution and ensure site staff are thoroughly trained on the scientific background of the trials.
• Resolve medical challenges and support CRAs on specific operational issues during clinical trial execution.

Scientific Engagement:

• Engage in peer-to-peer scientific exchange with KOLs, healthcare providers, and Population Health Decision Makers (PHDMs) to advance the company's scientific platform, implementation science-related projects aiming to improve patient outcomes.
• Collect, analyze and share early scientific insights by discussing development data with external experts and engaging with medical societies and patient advocacy groups.
• Act as a therapeutic area expert and provide leadership in the scientific community through advisory boards, scientific meetings, interactions with medical society stakeholders and engagement with HCP associations.

Cross-Functional Collaboration within General Medicine Therapeutis Area:

• Partner with clinical operations, regional teams, and cross-functional teams within the local affiliate to align on medical and scientific objectives.
• Engage with local functions, including Access, Commercial and Medical, to support local OLs and investigators in discussions on access planning and pre-launch, launch and post-launch preparations.
• Contribute scientific, clinical, and medical perspectives to national product strategy within a collaboratively optimized cross-functional team
• Collaborate across all field roles to create a coordinated and consistent "One Amgen" experience for healthcare providers.

Medical Training and Guidance:

• Provide timely and expert medical guidance to clinical staff, including the creation and delivery of training programs.
• Mentor other colleagues as appropriate, providing leadership in scientific exchange and strategic execution.
• Provide regular training to cross-functional internal Team on new data related to Amgen portfolio within General Medicine TA.

REQUIREMENTS

Core Competencies:

• Expertise in managing clinical trials from a medical perspective, with a strong understanding of Good Clinical Practice (GCP) and local regulations.
• Strong scientific acumen and the ability to communicate complex medical information effectively to diverse stakeholders.
• Demonstrated ability to build and maintain strong relationships with KOLs, investigators, and other key stakeholders.
• High level of initiative, innovation, and independence in performing tasks and prioritizing activities.

Qualifications:

• Scientific education (PhD, MD, PharmD)
• Minimum 2 years of experience within the biopharmaceutical industry

• Experience in managing clinical trials, particularly in study start-up and recruitment phases.
• Expertise in metabolic diseases is preferred
• Proven ability to engage with KOLs and drive scientific discussions that impact clinical trial execution and positioning and value of General Medicine portfolio in local market.

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