Principal Scientist (Director) Outcomes Research - Vaccines (Pneumococcal)

Job Description

Under the guidance of the Pneumococcal Vaccines Executive Director, Value & Implementation (V&I) Outcomes Research, the incumbent has the primary responsibilities for developing the integrated evidence strategy, including HTA/reimbursement and overall Real World evidence strategies, for pneumococcal vaccines on a worldwide basis and for planning and implementing Outcomes Research and Real World evidence programs to meet the value evidence needs of payers, health systems, and clinicians .

This includes direct interactions with HTA agencies, HTA/reimbursement experts and country affiliates to obtain in-depth understanding of country-specific HTA/reimbursement needs related to the product and all phases of outcomes research including design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic modeling. These activities include global responsibilities that are aligned with Customer Business Lines strategies and direct market responsibilities in the U.S. aligned with the U.S. Market strategy.  The incumbent contributes to product development and marketing strategies to ensure that product value is defined and developed. The Director also works closely with Product Development Teams, Franchise Teams, Regional Product Directors, country affiliates, Public Affairs, and Medical Education to ensure OR programs are consistent with marketing strategies in key countries.

The job duties include the following:

• Represents V&I Outcomes Research on one or more Value Teams (VT) and provide leadership in developing the evidence generation strategies and plans for developmental compounds and obtains cross-divisional senior management approval.

• Critically assesses drivers and barriers to reimbursement and market access and identifies value evidence needs to provide strategic input into clinical and market development programs.  Brings strong payer and HTA/reimbursement focus into the Product Development Team(s).

• Develops the integrated evidence strategy including HTA/OR strategy and generate evidences for HTA/ reimbursement purposes.

• Develop and evaluate health programs leveraging different parts of health care systems that can enhance value and use of our company products.

• Implements programs to document the burden and cost of diseases, unmet medical need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process and generates data on a worldwide basis to support pricing and reimbursement.

• Develops value evidence deliverables (e.g., global value dossier, health economic evaluations) and their adaptation to generate country-specific data supporting pricing and reimbursement.

• Works closely with the V&I or Value team members to develop OR plans for our company in-line and developmental products based on the regulatory, marketing and reimbursement environments on a worldwide basis, including the local needs of the US Market Works with the company's research and development division's colleagues, our company affiliates and consultants to write, coordinate, and validate as required, study design, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications.

• Works with our company Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.

• Supports our company country affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data collection forms for customization to countries, and in collaboration with our company affiliates, adaptation of the document according to local requirements. 

• Works closely with other departments to effectively develop/ communicate Outcomes Research findings/value evidence and support data and consistent messages throughout our company and to external customers.

• Responsible for maintaining awareness of scientific developments within his/her areas of expertise, both in terms of new methodology and new activities to establish communications with key outcomes research opinion leaders.

• Leverages other groups on the V&I team to develop and execute OR plans, including Market Partners, Data Sciences and Insights, and Pharmacoepidemiology.

• Builds relationships with health economic and outcomes research experts worldwide.

• Presents outcomes research data at international/national congresses and publishes articles in scientific journals.