23 days old

Medical Director, Global Medical Affairs - Inflammation/Allergy

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114926652
Amgen

Job ID: R-86196
Location: Thousand Oaks, CA, US 91360

Amgen's Global Medical organization is hiring a Medical Director to support Inflammation, specifically Allergy therapeutic area.

Responsibilities:
  • 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/or Medical TA Head, appropriate cross-functional teams and governance
  • 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
  • Synthesize and integrate insights to deliver medical inputs into relevant cross regional/functional strategies, including relevant brand strategy
  • Foster and enhance collaboration and coordination across Medical
  • Contribute to strategy development for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product
  • Lead/support relationships with external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange, where appropriate
  • Develop/support and lead/support execution of the strategy for medical evidence generation that shapes our products and informs the practice of medicine ensuring key needs are met in alignment with global product medical and relevant brand strategy
  • Foster Amgen's reputation as a science-based, innovative and patient-focused reliable partner
  • Develop and/or contribute to execution of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate
  • Partner with/support Global Regulatory Affairs and Safety (GRAAS) in risk management/minimization activities and ensure communication of the implications to internal/external stakeholders
  • Member and Medical representative of relevant leadership, governance and cross functional teams
  • May develop and manage medical product budget
  • Recruit, retain, coach, mentor, motivate and develop talent
  • Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
  • Ensure product/disease state/pipeline specific medical training where appropriate, may deliver training to others
  • Ensure appropriate clinical trial conduct as a key medical interface in close partnership with Global Development Operations (e.g. Site Management)
  • Provide strategic input into labels/regulatory/reimbursement/policy/promotional used to support internal/external interactions
  • Determine scientific/medical subject matter appropriateness of labels/regulatory/reimbursement/policy/promotional and medical deliverables (e.g., slide decks, publications, educational activities) used to support internal/external interactions via appropriate review process
  • Contribute to strategy development for, review, approve and ensure dissemination of, medical communications and related activities (e.g., product narrative, scientific platform, core content, publications including FPR/FLR, medical education and congresses)
  • Provide support and leadership of advisory boards and other relevant meetings (e.g., investigator meetings, and/or expert panels)
  • Lead/support the development of data interpretation, analysis and communication for medical executed studies
  • Provide decision on IME, Donations, medical grants and sponsorships
    • Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement
    • Understand the expectations of key external stakeholders to support appropriate access to Amgen therapies
    • In partnership with cross-functional team, ensure informed budget/resource trade-offs
  • Facilitates Investigator Sponsored Studies through Amgen governance and manage study lifecycle (including communicating with investigators, as appropriate and ensuring accurate reporting of key milestone data)
  • Contribute to lifecycle management plan


Basic Qualifications

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

AND

2 years of clinical research, basic science research, medical affairs or clinical development experience in pulmonary, allergy and immunology or dermatology

Preferred Qualifications

  • Doctor of Medicine (MD)
  • Specialty in Allergy and Immunology
  • 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 product/therapeutic area


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.

PI114926652

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86196<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen's Global Medical organization is hiring a Medical Director to support Inflammation, specifically Allergy therapeutic area.<br><br>Responsibilities:<br><ul><li>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/or Medical TA Head, appropriate cross-functional teams and governance</li><li>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</li><li>Synthesize and integrate insights to deliver medical inputs into relevant cross regional/functional strategies, including relevant brand strategy</li><li>Foster and enhance collaboration and coordination across Medical</li><li>Contribute to strategy development for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product</li><li>Lead/support relationships with external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange, where appropriate</li><li>Develop/support and lead/support execution of the strategy for medical evidence generation that shapes our products and informs the practice of medicine ensuring key needs are met in alignment with global product medical and relevant brand strategy</li><li>Foster Amgen's reputation as a science-based, innovative and patient-focused reliable partner</li><li>Develop and/or contribute to execution of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate</li><li>Partner with/support Global Regulatory Affairs and Safety (GRAAS) in risk management/minimization activities and ensure communication of the implications to internal/external stakeholders</li><li>Member and Medical representative of relevant leadership, governance and cross functional teams</li><li>May develop and manage medical product budget</li><li>Recruit, retain, coach, mentor, motivate and develop talent</li><li>Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs</li><li>Ensure product/disease state/pipeline specific medical training where appropriate, may deliver training to others</li><li>Ensure appropriate clinical trial conduct as a key medical interface in close partnership with Global Development Operations (e.g. Site Management)</li><li>Provide strategic input into labels/regulatory/reimbursement/policy/promotional used to support internal/external interactions</li><li>Determine scientific/medical subject matter appropriateness of labels/regulatory/reimbursement/policy/promotional and medical deliverables (e.g., slide decks, publications, educational activities) used to support internal/external interactions via appropriate review process</li><li>Contribute to strategy development for, review, approve and ensure dissemination of, medical communications and related activities (e.g., product narrative, scientific platform, core content, publications including FPR/FLR, medical education and congresses)</li><li>Provide support and leadership of advisory boards and other relevant meetings (e.g., investigator meetings, and/or expert panels)</li><li>Lead/support the development of data interpretation, analysis and communication for medical executed studies</li><li>Provide decision on IME, Donations, medical grants and sponsorships<ul><li>Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement</li><li>Understand the expectations of key external stakeholders to support appropriate access to Amgen therapies</li><li>In partnership with cross-functional team, ensure informed budget/resource trade-offs</li></ul></li><li>Facilitates Investigator Sponsored Studies through Amgen governance and manage study lifecycle (including communicating with investigators, as appropriate and ensuring accurate reporting of key milestone data)</li><li>Contribute to lifecycle management plan</li></ul><br><br><b>Basic Qualifications </b><br><br>MD or DO degree from an accredited medical school OR PharmD OR PhD<br><br>AND<br><br>2 years of clinical research, basic science research, medical affairs or clinical development experience in pulmonary, allergy and immunology or dermatology<br><br><b>Preferred Qualifications </b><br><br><ul><li>Doctor of Medicine (MD)</li><li>Specialty in Allergy and Immunology</li><li>Demonstrated ability as a medical expert in a complex matrix environment</li><li>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</li><li>Experience in regional/local medical practice and healthcare ecosystems</li><li>Skilled at engagement, scientific exchange with external medical community</li><li>Clinical research experience</li><li>Scientific publication experience (developing manuscripts and/or congress abstracts)</li><li>In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale</li><li>Familiarity with concepts of clinical research and clinical trial design, including biostatistics</li><li>Sound scientific and clinical judgement</li><li>Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements</li><li>Familiarity of local pharmaceutical industry and legal/health system environment</li><li>Skilled at effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication</li><li>History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues</li><li>Network of medical, clinical contacts in product/therapeutic area</li></ul><br><br>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.<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>#LI-POST<br><br>MD01<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/E5dml6tDy1dYSY5bsXman"> <p>PI114926652</p>

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Posted: 2019-10-29 Expires: 2019-11-29

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Medical Director, Global Medical Affairs - Inflammation/Allergy

Amgen
Thousand Oaks, CA 91360

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