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.
The Associate Director / Director, Patient Centered Science will develop and lead strategies for generating patient experience data to support the evidence needs of regulatory, payers, prescribers and patients.
The role is dedicated to our Oncology therapeutic area and will require an in-depth understanding of patient-centered outcomes research within the context of pharmaceutical development.
As a PCS director you will lead the development of patient experience strategies within your area to optimize the needs of various stakeholders.
In the role you will :
Set and lead TA and study specific strategies to represent the patient experience to regulators, patients, Healthcare Professionals (HCPs) and payers,
Determine and deliver guidance on which therapy / disease areas and early projects that will need a PRO as endpoint and description of patient experience,
Investigate to what extent Patient Reported Outcomes (PRO) and Clinical Outcome Assessment (COA) endpoints are developed, fit-for-purpose and approved by Regulatory Authorities and how well they will meet AstraZeneca’s project needs, to provide the most appropriate PRO strategic recommendation to meet all key stake holder needs work cross-functionally.
The incumbent will be responsible for driving high quality evidence claims by working with assigned therapeutic area (TA), focusing on projects within the Oncology field (and their underlying projects) across the development cycle, in cross functional teams within AstraZeneca.
As a PCS director you will interact with regulatory authorities, payers and key external experts, as well as with relevant AstraZeneca’s cross-functional teams, to provide PRO related leadership to assigned projects, and will be accountable for TA PCS standards, the input to Target Product Profiles (TPPs) / Target Product Claims (TPC) and clinical plans.
Key Accountabilities / Responsibilities
Deliver robust TA and project PCS regulatory recommendations globally to meet regulatory, payer and patient needs.
Develop relationships with appropriate AstraZeneca teams as well as with key external experts and collaborative groups (within the relevant disease area) to enhance AstraZeneca’s reputation of PRO measurement.
Deliver expert input on PRO needs to TPPs, TPCs and support PRO dossier and briefing document evidence within clinical plans and regulatory submissions.
Ensure appropriate PRO and COA input is included at the design stages of clinical programs and drive appropriate data collection plans and analyses to ensure high quality interpretation of the resulting data.
Proactively and independently contribute to research planning process and resolution of complex issues, which may impact investment decisions and the external acceptance of evidence for product.
Project management and expert consultation supporting patient centered / PRO measurement in clinical programs, and dissemination of results and messages to all key stakeholders in all different phases (design to interpretation).
Support regulatory and payer interactions by developing patient experience evidence for inclusion in submissions and support teams via participation in meetings with decision makers (e.
g. FDA, EMA, NICE, G-BA, etc.)
Advance expertise in PRO / COA research through presentations, publications, and internal / external engagement.
Minimum Requirements Education and Experience
Bachelor’s degree in clinical, biological, or social sciences or equivalent
Master’s degree in relevant field (outcomes research, health services research, epidemiology, health policy or related fields)
Doctoral degree in relevant field preferred
Relevant experience of COA / PRO scientific work
Minimum of 5 years’ experience in the biopharmaceutical industry or equivalent
Excellent knowledge in clinical development and research study designs and interpretation.
Good understanding of qualitative and quantitative analyses to gain insights on patient experience
Effectiveness in a scientific advisory role involving both strategic and tactical elements
Knowledge of therapeutic area
Open to periods of travel
Skills and Capabilities
In-depth or expert knowledge of PRO / COA
Knowledge of international healthcare systems and their changing needs for PRO / COA information.
PRO / COA and its application to pharmaceutical development at an international level.
Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages.
Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims.
Leadership skills and problem-solving capability as demonstrated by ability to evaluate challenges and opportunities for PRO strategy and modify as appropriate.
Well-developed conceptual thinking with capability to access internal and external resources for advice.
Integrity and high ethical standards
The PCS group at AstraZeneca is passionate about including patient perspective in drug development, we are a vibrant and diverse group that enjoys leading and advancing the field of patient centered science.
If you are passionate about patient perspective as we are, send your application now!
For more information about the position please contact : Nikunj Patel, Group Director, Patient Centered Science : Oncology at nikunj.
patel astrazeneca.com or +1 202 515 1463
Welcome with your application no later than January 31st, 2020
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.