20 days old

Value & Access Director - Patient-Centered Outcomes

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115671313
Amgen

Job ID: R-81431
Location: Thousand Oaks, CA, US 91360

The Value & Access Director -- Patient-Centered Outcomes (PCO) will be responsible for supporting product teams (PTs) in the development and implementation of patient-reported outcome (PRO), clinical outcome assessment (COA) and other patient-centered measurement strategies. The Director will facilitate the inclusion of patient insights into the clinical development program, contributing PCO strategies and expertise to support access of our therapeutics to patients. The Director will engage with cross-functional teams and key stakeholders to partner in the incorporation of the PCO strategy within the evidence generation plan. The role provides PCO strategy development and execution expertise during clinical trials at study level, program level and across therapeutic areas. In addition, the Director will build and expand their professional network, acting as a representative for PCO research within Amgen and externally with patients, clinicians, regulatory bodies and payers.

Key accountabilities include:
  • Development of PCO therapeutic-area and product-level strategic options for presentation to Franchise Steering Committee (FSC) and PT
  • Incorporating patient-focused outcomes throughout drug development by driving development and execution of sound PRO strategies and methodologies
  • Ensuring rigor and expertise is applied to PCO decision-making on analyses related to: PRO strategy, PRO development and validation, psychometrics, ePRO integration and PRO translations
  • Working with the GHE Product Lead (GHE PL) on embedding the PCO strategy into the evidence generation plan as part of the overall value-evidence generation strategy
  • Development of materials to support and engaging in regulatory interactions on PCOs (e.g. regulatory briefings, etc.)
  • Driving initiatives to capture, share and incorporate PCO best practices and regulatory guidance across the organization
  • Developing and enforcing PCO SOPs and guidance w/Team Head


Basic Qualifications:

Doctorate degree and 4 years of health economics and/or outcomes research and/or market access and/or market research experience

OR

Master's degree and 7years of health economics and/or outcomes research and/or market access and/or market research experience

OR

Bachelor's degree and 9 years of health economics and/or outcomes research and/or market access and/or market research experience

Preferred Qualifications:

Graduate degree in health economics and/or epidemiologic statistical and analytical methodologies

6+ years of industry experience in the Biotechnology, Pharmaceutical, or other Healthcare related field

5+ years of experience in Health Outcomes role, specializing in patient-reported outcomes

Experience in the development and validation of PROs, such as utilizing regulatory guidance to develop a conceptual framework, performing qualitative research, creating a de novo PRO, validating PROs using CDIs, and/or performing psychometrics for quantitative validation

Patient experience market research

Broad therapeutic area expertise

Experience incorporating PROs into a pre-commercial study

Experience supporting and leading regulatory interactions related to PROs

Experience supporting and leading advocacy and special-interest group activities

Very passionate about patient-centric drug development and patient-centricity

Ability to influence with and without authority

Understands and navigates a matrixed and, at times, ambiguous environment

Strong verbal and written communication skills

Strong clinical, health economics, and commercial acumen and instincts

Understanding of a range of market, policy, social, and economic influences and trends that may impact drug development and commercialization

Demonstrated creativity in addressing strategic challenges; thinks outside-the-box; asks the right questions; seeks expert opinions and insights; applies innovative ideas and takes measured risks

Ability to develop and articulate a strong value proposition

Works effectively in a team-based organization, collaborates cross functionally, builds alignment around key objectives and exercises influence at all levels

Ability to build consensus and achieve agreement on key priorities

Understanding of healthcare ecosystems, patient, payer, HTA and HCP decision-making, and value drivers for each of those stakeholders across global markets

Understanding of key industry, policy and market trends impacting patients and all PCO-related developments

Understanding of how different trial designs and outcomes may influence clinical guidelines, market access and reimbursement

Understanding of the evidentiary requirements and decision-making process of HTA agencies related to PROs

Significant understanding of regulatory policy issues relating to PROs, HTA decision-making, drug value and reimbursement across the major global healthcare markets

Skilled at influence and persuasion: able to convince others to act on information or recommendations based on compelling logic or common best interests

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.

PI115671313

<b>Amgen</b><br/><br/><b>Job ID: </b>R-81431<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Value & Access Director -- Patient-Centered Outcomes (PCO) will be responsible for supporting product teams (PTs) in the development and implementation of patient-reported outcome (PRO), clinical outcome assessment (COA) and other patient-centered measurement strategies. The Director will facilitate the inclusion of patient insights into the clinical development program, contributing PCO strategies and expertise to support access of our therapeutics to patients. The Director will engage with cross-functional teams and key stakeholders to partner in the incorporation of the PCO strategy within the evidence generation plan. The role provides PCO strategy development and execution expertise during clinical trials at study level, program level and across therapeutic areas. In addition, the Director will build and expand their professional network, acting as a representative for PCO research within Amgen and externally with patients, clinicians, regulatory bodies and payers.<br><br>Key accountabilities include:<br><ul><li>Development of PCO therapeutic-area and product-level strategic options for presentation to Franchise Steering Committee (FSC) and PT</li><li>Incorporating patient-focused outcomes throughout drug development by driving development and execution of sound PRO strategies and methodologies</li><li>Ensuring rigor and expertise is applied to PCO decision-making on analyses related to: PRO strategy, PRO development and validation, psychometrics, ePRO integration and PRO translations</li><li>Working with the GHE Product Lead (GHE PL) on embedding the PCO strategy into the evidence generation plan as part of the overall value-evidence generation strategy</li><li>Development of materials to support and engaging in regulatory interactions on PCOs (e.g. regulatory briefings, etc.)</li><li>Driving initiatives to capture, share and incorporate PCO best practices and regulatory guidance across the organization</li><li>Developing and enforcing PCO SOPs and guidance w/Team Head</li></ul><br><br><b> Basic Qualifications: </b><br><br>Doctorate degree and 4 years of health economics and/or outcomes research and/or market access and/or market research experience<br><br> OR <br><br> Master's degree and 7years of health economics and/or outcomes research and/or market access and/or market research experience<br><br> OR <br><br> Bachelor's degree and 9 years of health economics and/or outcomes research and/or market access and/or market research experience<br><br><b> Preferred Qualifications: </b><br><br>Graduate degree in health economics and/or epidemiologic statistical and analytical methodologies<br><br>6+ years of industry experience in the Biotechnology, Pharmaceutical, or other Healthcare related field <br><br>5+ years of experience in Health Outcomes role, specializing in patient-reported outcomes <br><br>Experience in the development and validation of PROs, such as utilizing regulatory guidance to develop a conceptual framework, performing qualitative research, creating a de novo PRO, validating PROs using CDIs, and/or performing psychometrics for quantitative validation <br><br>Patient experience market research<br><br>Broad therapeutic area expertise <br><br>Experience incorporating PROs into a pre-commercial study <br><br>Experience supporting and leading regulatory interactions related to PROs <br><br>Experience supporting and leading advocacy and special-interest group activities <br><br>Very passionate about patient-centric drug development and patient-centricity <br><br>Ability to influence with and without authority <br><br>Understands and navigates a matrixed and, at times, ambiguous environment <br><br>Strong verbal and written communication skills <br><br>Strong clinical, health economics, and commercial acumen and instincts <br><br>Understanding of a range of market, policy, social, and economic influences and trends that may impact drug development and commercialization <br><br>Demonstrated creativity in addressing strategic challenges; thinks outside-the-box; asks the right questions; seeks expert opinions and insights; applies innovative ideas and takes measured risks <br><br>Ability to develop and articulate a strong value proposition <br><br>Works effectively in a team-based organization, collaborates cross functionally, builds alignment around key objectives and exercises influence at all levels <br><br>Ability to build consensus and achieve agreement on key priorities <br><br>Understanding of healthcare ecosystems, patient, payer, HTA and HCP decision-making, and value drivers for each of those stakeholders across global markets <br><br>Understanding of key industry, policy and market trends impacting patients and all PCO-related developments <br><br>Understanding of how different trial designs and outcomes may influence clinical guidelines, market access and reimbursement <br><br>Understanding of the evidentiary requirements and decision-making process of HTA agencies related to PROs <br><br>Significant understanding of regulatory policy issues relating to PROs, HTA decision-making, drug value and reimbursement across the major global healthcare markets <br><br>Skilled at influence and persuasion: able to convince others to act on information or recommendations based on compelling logic or common best interests <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/OaAp7pHE2zyQTDqdupBkx"> <p>PI115671313</p>

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Posted: 2019-11-21 Expires: 2019-12-22

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Value & Access Director - Patient-Centered Outcomes

Amgen
Thousand Oaks, CA 91360

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