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Medical Director, US Medical Lead - Nephrology

Company: Amgen
Location: Thousand Oaks
Posted on: November 21, 2019

Job Description:

AmgenJob ID: R-87678Location: Thousand Oaks, CA, US 91360The US Medical Leader for Nephrology is responsible for the development and implementation of US Medical strategy.

This role is responsible for:

  • The development and execution of US Nephrology products medical strategy, via the US Medical Plan in collaboration with the Global Medical Leader, Global Development Leader, Product Team/Portfolio Governance and alignment with Global strategy
  • Identification of scientific evidence gaps, development of US evidence generation strategy in coordination with the Global team
  • Participating in engagement of external key stakeholders (often in partnership with other functions)
  • Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
  • Supports implementation of Medical governance for respective product, which includes:
    • Safety and pharmacovigilance as a key and effective partner with GRAAS
    • Clinical trial conduct
    • US risk management/minimization in collaboration with GRAAS
    • Subject matter appropriateness (medical/scientific) of external interactions (e.g. Copy review, multichannel, congresses, 1-1 interactions, etc.)
    • Ensuring appropriate medical support of compliance

      Key Activities:
      • Maximizes Amgen's value proposition of Amgen's Nephrology products in the US through management and delivery of all medical and scientific activities in alignment with Global strategy and Evidence Generation Team (EGT)
        • Participates in development of US cross functional strategy and supports medical execution.
        • Provides input into medical and scientific insight for incorporation into US product strategies, via the US Medical Plan, and provides insights into Global strategies, plans and tactics as a participant in the Commercialization process
        • Ensures understanding and incorporation of patient perspectives in all activities
        • Executes product-specific US evidence generation strategy, in alignment with EGT, and supports execution of data communication strategy
        • Supports product-specific US clinical trial execution
        • Medical / Scientific contribution to Value Dossiers, compendia and interactions with payers in collaboration with VA&P
        • Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
        • May participate in speaking engagements that represent Amgen to external and internal bodies on medical and scientific issues related to relevant products
        • Participates in the review of investigator sponsored studies
        • Supports or implements external Stakeholder Strategy
          • Engagement strategy and execution with medical experts, professional societies, patient groups and other key stakeholders
          • Participates in advocacy from a medical perspective in partnership with Commercial, Government Affairs and GRAAS policy
          • Builds Amgen's reputation as a science-based and patient-focused reliable partner
          • Ensures Medical Governance
            • Ensures human subject safety for marketed product in cooperation and effective partnership with responsible functions (e.g., GRAAS, Global Development)
            • May support US clinical trial conduct
            • Participates with the MAC operating committee in the material reviews.
            • Actively participates in US risk management/minimization in collaboration with GRAAS
            • May decide subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc.)
            • Ensures appropriate medical leadership of compliance; accountable for the conduct of medical activities according to all relevant compliance standards, regulations and SOP`s; Role models appropriate and compliant behaviors and contributes to creating a climate of compliance adherence across the organization

              Basic Qualifications

              MD or DO degree from an accredited medical school

              AND

              2 years of clinical research, basic science research, medical affairs or clinical development experience

              Preferred Qualifications

              • Accredited fellowship in Nephrology (board certified or board eligible)
              • 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, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs
              • Experience in regional/local medical practice and healthcare ecosystems
              • Skilled at engagement, scientific exchange with external medical community
              • Clinical research experience
              • Scientific publication experience (developing manuscripts and/or congress abstracts)
              • 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 judgement
              • Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements
              • Familiarity of local pharmaceutical industry and legal/health system 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 in nephrology

                We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

                Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

                Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

                #LI-POST

                MD01

                Join Us

                If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

                Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

                As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

                Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI115407285

Keywords: Amgen, Buena Park , Medical Director, US Medical Lead - Nephrology, Healthcare , Thousand Oaks, California

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