26 days old

Medical Director - Global Medical Affairs - Omecamtiv Mecarbil Companion Diagnostics

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117317637
Amgen

Job ID: R-91646
Location: Thousand Oaks, CA, US 91360

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 cDx
  • Work with all relevant cross-functional stakeholders to develop the medical affairs strategy for OM cDx
  • Coordinate the OM cDX medical affairs activities in synchronization with the other program activities
  • Partner with regions and countries to execute the OM cDx strategy
  • Lead Scientific Advisory boards and other meetings with Opinion Leaders
  • Conduct individual Opinion Leader and Pathologist interactions
  • Develop and execute the global OL engagement plan and the insights collection plan for the OM cDx
  • Lead the medical OM cDx strategy around major congresses
  • Review Investigator sponsored study (ISS) proposals, collaborative agreements, Real World Evidence, and other types of research proposals concerning the OM companion diagnostics
  • Interact with professional societies and advocacy groups for coordination of activities around OM cDx education and awareness
  • Support partnerships for the global launch preparation and post-launch activities for the OM cDX
  • Partner with all relevant stakeholders for the develop the evidence generation plan and the life cycle management plan for the OM cDx
  • Participate in Diagnostic Development Team meetings for relevant programs
  • Facilitate and continue to build Amgen's role as a science-based, patient-focused partner
  • Determine resource and budget allocation necessary to deliver on global medical strategy


Basic Qualifications

MD/DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of medical affairs experience or pharmaceutical industry experience

Preferred Qualifications
  • MD plus accredited fellowship in Pathology
  • Strong foundation in Life Sciences e.g. Molecular Biology, Pathology
  • Experience with clinical companion diagnostic development
  • 5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Experience with stakeholder engagement and interactions ( e.g. , OLs, advocacy groups, payers)
  • Familiarity with global regulatory organizations, guidelines, and practices
  • Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
  • Knowledge 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 diagnostics
  • History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
  • In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale
  • Track record of success collaborating in matrixed cross-functional teams
  • Outstanding written and verbal communication skills


Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity.

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.

MD01

#LI-POST

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.

PI117317637

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91646<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>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.<br><br> 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: <br><br><ul><li>Develop and execute the global medical plan for the OM cDx</li><li>Work with all relevant cross-functional stakeholders to develop the medical affairs strategy for OM cDx</li><li>Coordinate the OM cDX medical affairs activities in synchronization with the other program activities</li><li>Partner with regions and countries to execute the OM cDx strategy</li><li>Lead Scientific Advisory boards and other meetings with Opinion Leaders</li><li>Conduct individual Opinion Leader and Pathologist interactions</li><li>Develop and execute the global OL engagement plan and the insights collection plan for the OM cDx</li><li>Lead the medical OM cDx strategy around major congresses</li><li>Review Investigator sponsored study (ISS) proposals, collaborative agreements, Real World Evidence, and other types of research proposals concerning the OM companion diagnostics</li><li>Interact with professional societies and advocacy groups for coordination of activities around OM cDx education and awareness</li><li>Support partnerships for the global launch preparation and post-launch activities for the OM cDX</li><li>Partner with all relevant stakeholders for the develop the evidence generation plan and the life cycle management plan for the OM cDx</li><li>Participate in Diagnostic Development Team meetings for relevant programs</li><li>Facilitate and continue to build Amgen's role as a science-based, patient-focused partner</li><li>Determine resource and budget allocation necessary to deliver on global medical strategy</li></ul><br><br><b>Basic Qualifications </b><br><br>MD/DO degree from an accredited medical school OR PhD OR PharmD<br><br>AND<br><br>2 years of medical affairs experience or pharmaceutical industry experience<br><br><b>Preferred Qualifications </b><br><ul><li>MD plus accredited fellowship in Pathology</li><li> Strong foundation in Life Sciences e.g. Molecular Biology, Pathology </li><li>Experience with clinical companion diagnostic development</li><li>5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers</li><li>Experience with stakeholder engagement and interactions ( e.g. , OLs, advocacy groups, payers)</li><li>Familiarity with global regulatory organizations, guidelines, and practices</li><li>Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines</li><li>Knowledge 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 diagnostics</li><li>History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues</li><li>In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale</li><li>Track record of success collaborating in matrixed cross-functional teams</li><li>Outstanding written and verbal communication skills</li></ul><br><br>Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity.<br><br>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.<br><br>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.<br><br>MD01<br><br>#LI-POST<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/eo2zRehNQ655IjxYhdXDl"> <p>PI117317637</p>

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Posted: 2020-01-22 Expires: 2020-02-22

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Medical Director - Global Medical Affairs - Omecamtiv Mecarbil Companion Diagnostics

Amgen
Thousand Oaks, CA 91360

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