17 days old

Value & Access Manager - Clinical Outcome Assessment (COA) Specialist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117761916
Amgen

Job ID: R-92777
Location: Thousand Oaks, CA, US 91360

The COA (Clinical Outcome Assessment) Specialist resides within the PCOR (Patient Centered Outcomes Research) Hub in GHE (Global Heath Economics). The PCOR Hub is a dedicated team working cross-functionally in leading the development of PCO strategy across Amgen's Therapeutic Areas to ensure consistent execution and maximize PCO value. This role serves as a specialist in PCOR for Amgen COAs (Clinical Outcome Assessments) -- the measurement instruments in outcomes research. The successful candidate will work in various therapeutic areas across Amgen's entire pipeline and product teams, and will partner closely with GHE and GCPM (Global Clinical Program Management) individuals with direct influence on multiple clinical trial designs and measurement tool selection. The Specialist is accountable for working with evidence generation teams across the pipeline to ensure the COAs reflect the teams' strategies and ensure proper licensing and linguistically validated translations for each measure.

The role is expected to partner effectively with cross functional leads to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality. This person will also serve as subject matter authority representing COA license requirements in support of key process transformation projects, functional governance groups, and/or cross functional projects.

Key Responsibilities include:

Developing relationships with Evidence Generation Teams and Clinical Study Teams to identify, obtain, track and maintain COA licenses to support clinical trials

Serving as an Amgen COA License Specialist to ensure the study teams strategy is reflective of the COAs selected

Assist in COA strategy during product evidence generation

Develop knowledge and relationships with applicable COA licensees

Assist in the design, development, and tracking of a spectrum of COAs across Amgen including study specific COA licenses, COAs with no license, Amgen developed / owned COAs, and high value MLAs (Master License Agreements), as well as tracking and budget management for a COA database subscription

Lead vendor relationship for out licensing of Amgen developed / owned COAs

Partner closely with the eCOA technical specialist to ensure COAs are accurately translated to eCOAs

Work effectively with Global Supplier Governance (GSS) with regards to high value Master License Agreements.

Work optimally with Supplier Performance Management (SPM) with regards challenges with licensees.

Obtain, review and act as signatory on COA licenses to ensure that the study specific COA licenses are in place as needed for the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.

Centrally track COA licensee contacts, requirements, linguistic validation of translations, contractual status and expiry, as well as maintain the COA portal and the COA library.

Support the internal team in managing project related timelines and associated activities

Identify and track study-related COA license issues to resolution

Provide a supportive framework for continuous process and quality improvements

Basic Qualifications:

Doctorate degree

Or

Master's degree and 2 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience

Or

Bachelor's degree and 4 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience

Or

Associate's degree and 10 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience

Or

High school diploma / GED and 12 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience

Preferred Qualifications:

Experience implementing COAs / PROs in the pharmaceutical/biotechnology industry or working on incorporating COAs / PROs from a regulatory perspective

Ability to work effectively in a team-based organization, collaborate cross functionally, build alignment around key objectives and exercise influence at all levels

Sound problem resolution, judgment, and decision-making abilities

Excellent time management and organization skills

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen is committed to unlocking the potential 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.

Global Health Economics contributes by ensuring patient and payer perspectives are incorporated into the value generated for these innovative biologics. The department is committed to developing comprehensive evidence packages across cost modeling, database analysis, and patient reported outcomes to achieve unparalleled health technology submissions.

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.

PI117761916

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92777<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The COA (Clinical Outcome Assessment) Specialist resides within the PCOR (Patient Centered Outcomes Research) Hub in GHE (Global Heath Economics). The PCOR Hub is a dedicated team working cross-functionally in leading the development of PCO strategy across Amgen's Therapeutic Areas to ensure consistent execution and maximize PCO value. This role serves as a specialist in PCOR for Amgen COAs (Clinical Outcome Assessments) -- the measurement instruments in outcomes research. The successful candidate will work in various therapeutic areas across Amgen's entire pipeline and product teams, and will partner closely with GHE and GCPM (Global Clinical Program Management) individuals with direct influence on multiple clinical trial designs and measurement tool selection. The Specialist is accountable for working with evidence generation teams across the pipeline to ensure the COAs reflect the teams' strategies and ensure proper licensing and linguistically validated translations for each measure.<br><br>The role is expected to partner effectively with cross functional leads to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality. This person will also serve as subject matter authority representing COA license requirements in support of key process transformation projects, functional governance groups, and/or cross functional projects.<br><br><b>Key Responsibilities include: </b><br><br>Developing relationships with Evidence Generation Teams and Clinical Study Teams to identify, obtain, track and maintain COA licenses to support clinical trials<br><br>Serving as an Amgen COA License Specialist to ensure the study teams strategy is reflective of the COAs selected<br><br>Assist in COA strategy during product evidence generation<br><br>Develop knowledge and relationships with applicable COA licensees<br><br>Assist in the design, development, and tracking of a spectrum of COAs across Amgen including study specific COA licenses, COAs with no license, Amgen developed / owned COAs, and high value MLAs (Master License Agreements), as well as tracking and budget management for a COA database subscription<br><br>Lead vendor relationship for out licensing of Amgen developed / owned COAs<br><br>Partner closely with the eCOA technical specialist to ensure COAs are accurately translated to eCOAs<br><br>Work effectively with Global Supplier Governance (GSS) with regards to high value Master License Agreements.<br><br>Work optimally with Supplier Performance Management (SPM) with regards challenges with licensees.<br><br>Obtain, review and act as signatory on COA licenses to ensure that the study specific COA licenses are in place as needed for the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.<br><br>Centrally track COA licensee contacts, requirements, linguistic validation of translations, contractual status and expiry, as well as maintain the COA portal and the COA library.<br><br>Support the internal team in managing project related timelines and associated activities<br><br>Identify and track study-related COA license issues to resolution<br><br>Provide a supportive framework for continuous process and quality improvements<br><br><b>Basic Qualifications: </b><br><br>Doctorate degree<br><br>Or<br><br>Master's degree and 2 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience<br><br>Or<br><br>Bachelor's degree and 4 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience<br><br>Or<br><br>Associate's degree and 10 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience<br><br>Or<br><br>High school diploma / GED and 12 years of health economics and outcome research and/or clinical development and/or clinical quality assurance experience<br><br><b>Preferred Qualifications: </b><br><br>Experience implementing COAs / PROs in the pharmaceutical/biotechnology industry or working on incorporating COAs / PROs from a regulatory perspective<br><br>Ability to work effectively in a team-based organization, collaborate cross functionally, build alignment around key objectives and exercise influence at all levels<br><br>Sound problem resolution, judgment, and decision-making abilities<br><br>Excellent time management and organization skills<br><br>Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.<br><br>Amgen is committed to unlocking the potential 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>Global Health Economics contributes by ensuring patient and payer perspectives are incorporated into the value generated for these innovative biologics. The department is committed to developing comprehensive evidence packages across cost modeling, database analysis, and patient reported outcomes to achieve unparalleled health technology submissions.<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/Y7LZxyTlqbbwhpLqiVXpx"> <p>PI117761916</p>

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Posted: 2020-02-04 Expires: 2020-03-06

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Value & Access Manager - Clinical Outcome Assessment (COA) Specialist

Amgen
Thousand Oaks, CA 91360

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