Value & Access Director - Patient-Centered Outcomes

Company: Amgen
Location: Thousand Oaks
Posted on: March 17, 2020

Job Description:

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. This position is located at Amgen's corporate headquarters in Thousand Oaks, California. 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 7 years 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.

Keywords: Amgen, Thousand Oaks , Value & Access Director - Patient-Centered Outcomes, Executive , Thousand Oaks, California