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 the patient experience and by generating impactful evidence to demonstrate the value of our medicines and support decision making by patients, physicians, regulators, and payers. We are expanding our team to include an additional Patient-Centered Science Manager who will play a pivotal role in building our scientific capabilities and bringing the patient perspective into the drug development process. This position will require an understanding of patient-centered outcomes research within the context of pharmaceutical development. The role is dedicated to our Respiratory therapeutic area. 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) in clinical trials to generate high quality evidence that will support the regulatory approval, commercialization, and reimbursement of products. In this role, you will be driving the following activities to ensure efficient implementation of PRO into studies: * Support patient experience strategy development and translate the patient experience strategy into a fully implemented program * Interact with internal AstraZeneca teams and externally with PRO strategic partners, linguistic validation and eCOA providers, with regulatory authorities and key external experts * Lead PCS function interactions with internal and external teams to apply strategy at the study level and oversee PRO implementation * Oversee implementation of the scientific aspect of the electronic capture of COA (eCOA) * Support development of relevant PRO training materials for patients, investigators, and study monitors * Ensure appropriate standards are applied to all strategy delivery activities and participate in the development of new standards to further optimize strategy delivery. Key Accountabilities/Responsibilities * Manage the day-to-day activities of PRO implementation in clinical 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 text for study Statistical Analysis Plans (SAP) * Manage relationships with vendors and ensure their deliverables (e.g., strategy/tactical plans, linguistic validations, interview studies, etc.) * Provide scientific expertise for eCOA implementation * Perform blinded review of clinical study data * Assist with review of study results and preparation of regulatory documents Minimum Requirements -Education and Experience * Baccalaureate degree in biomedical or social sciences discipline or equivalent * Familiarity with pharmaceutical clinical research from industry or contract research organization work experience * Experience with PRO development and usage in clinical studies is preferred but not required Skills and Capabilities * Ability to manage and prioritize several projects simultaneously, including dealing with risk and issue management * Ability to clearly define project scopes and provide appropriate support * Ability to collaborate effectively with internal and external stakeholders * Ability to seek out and champion more efficient and effective methods/process * Excellent written and verbal communication skill * Integrity and high ethical standards The PCS group at AstraZeneca is a diverse and growing team with a passion for bringing the patient perspective into drug development. If you're interested in joining a science-focused team working to make a positive impact on patients' lives, send your application now! For more information about the position please contact Sean O'Quinn, Patient-Centered Science Group Director, Respiratory Email: Sean.OQuinn(at)astrazeneca.com Phone: +1 (301) 398 5065 Please submit your application no later than January 30, 2020.