Patient Centered Science Manager
AstraZeneca is committed to putting patients first. This strong focus on patients shapes how we manage all aspects of our business. The Patient Centered Science (PCS) group plays an integral role in fulfilling this commitment by developing strategies to capture patient experience and generating impactful evidence to demonstrate the value of our medicines and support decision making by regulators, patients, physicians and payers. We are expanding our team to include Patient Centered Science Manager to play a pivotal role in challenging our scientific capabilities to make a positive impact on changing patients lives and include patient perspective into drug development. The role is dedicated to our Oncology therapeutic area and will require an understanding of patient-centered outcomes research within the context of pharmaceutical development. As a PCS manager you will work closely with PCS Directors and study teams to implement Patient Reported Outcomes (PRO) and other Clinical Outcomes Assessments (COA) into clinical trials to ensure high quality evidence supporting products regulatory approval, reimbursement and commercialization. In the role you will be driving efficient implementation of PRO into studies, with the following activities: * To translate the patient experience strategy into a fully implemented program * Lead PCS function interactions with internal and external teams to apply strategy at the study level to oversee PRO implementation * Responsible for the scientific aspect of the electronic capture of COA (eCOA) implementation * Support the patient experience strategy development * Support development of relevant PRO training materials for patients, investigators and monitors * Ensure appropriate standards are applied and participate in development of new standards You will interact with internal AstraZeneca teams and externally with PRO strategic partners, linguistic validation and eCOA providers, with regulatory authorities and key external experts. Key Accountabilities/Responsibilities * Drive the everyday work of PRO implementation in studies * Support PCS directors in the development of patient experience strategies * Draft Clinical Study Protocol (CSP) text based on the pre-defined patient experience strategy * Draft PRO (Statistical Analysis Plan) SAP text * Provide support to manage the relationship with vendors, and oversee their deliverables (strategies, linguistic validation interview studies etc) * Provide scientific expertise of eCOA implementation * Perform blinded data review * Assist with review of results and the preparation of regulatory documents Minimum Requirements -Education and Experience * Bachelor's degree in clinical, biological, or social sciences or equivalent * Familiarity with clinical research from industry or CRO work experience * Experience with PRO development and usage in clinical studies is preferred but not required Skills and Capabilities * Able to implement projects including interactions with stakeholders * Good written and verbal communication skills * Ability to define clear scope of projects and provide support * Ability to look for a champion more efficient and effectively methods/process * Integrity and high ethical standards The PCS group at AstraZeneca consist of nearly 20 persons, with a passion for including patient perspective in drug development, we are a group with diversity that enjoy leading and develop the field of patient centered science. Do you want to work in a vibrant group this is your opportunity, send your application now! For more information about the position please contact: Nikunj Patel, Group Director, Patient Centered Science: Oncology at nikunj.patel(at)astrazeneca.com Welcome with your application no later than February 9, 2020.