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Medical Director - Global Medical Affairs - Omecamtiv Mecarbil Companion Diagnostics

Company: Amgen
Location: Thousand Oaks
Posted on: March 22, 2020

Job Description:

The Global Medical Affairs Director - Omecamtiv Mecarbil (OM) Companion Diagnostics(cDX) is accountable for the development and execution of global medical affairs strategy for Omecamtiv Mecarbil companion diagnostics.The Global Medical Affairs Director will work closely with cross-functional partners, regions and countries for coordination of all OM companion diagnostic activities and will:Develop and execute the global medical plan for the OM cDxWork with all relevant cross-functional stakeholders to develop the medical affairs strategy for OM cDxCoordinate the OM cDX medical affairs activities in synchronization with the other program activitiesPartner with regions and countries to execute the OM cDx strategyLead Scientific Advisory boards and other meetings with Opinion LeadersConduct individual Opinion Leader and Pathologist interactionsDevelop and execute the global OL engagement plan and the insights collection plan for the OM cDxLead the medical OM cDx strategy around major congressesReview Investigator sponsored study (ISS) proposals, collaborative agreements, Real World Evidence, and other types of research proposals concerning the OM companion diagnosticsInteract with professional societies and advocacy groups for coordination of activities around OM cDx education and awarenessSupport partnerships for the global launch preparation and post-launch activities for the OM cDXPartner with all relevant stakeholders for the develop the evidence generation plan and the life cycle management plan for the OM cDxParticipate in Diagnostic Development Team meetings for relevant programsFacilitate and continue to build Amgen's role as a science-based, patient-focused partnerDetermine resource and budget allocation necessary to deliver on global medical strategyBasic QualificationsMD/DO degree from an accredited medical school OR PhD OR PharmDAND2 years of medical affairs experience or pharmaceutical industry experiencePreferred QualificationsMD plus accredited fellowship in PathologyStrong foundation in Life Sciences e.g. Molecular Biology, PathologyExperience with clinical companion diagnostic development5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payersExperience with stakeholder engagement and interactions (e.g., OLs, advocacy groups, payers)Familiarity with global regulatory organizations, guidelines, and practicesKnowledge of Good Clinical Practices (GCP) and global regulations and guidelinesKnowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs specifically related to companion diagnosticsHistory of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issuesIn-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationaleTrack record of success collaborating in matrixed cross-functional teamsOutstanding written and verbal communication skills

Keywords: Amgen, Thousand Oaks , Medical Director - Global Medical Affairs - Omecamtiv Mecarbil Companion Diagnostics, Executive , Thousand Oaks, California

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