ROLE SUMMARY

The Evidence Generation Platform – Real World Evidence (RWE) is a rapidly expanding group that provides integrated, end-to-end RWE optimization, education, communication, and maximization of data partnerships’ value within therapeutic areas (TAs) to meet both core and innovative Development, Regulatory and Commercial needs to support breakthroughs to change patients’ lives.

The Vaccines TA is responsible for creating one of the greatest health advancements of all time, resulting in control, near-elimination or elimination of infectious diseases that were once pervasive. Cross-functional pipeline and asset teams create and deliver vaccines for high impact infections such as pneumococcal disease, meningitis, hospital acquired infections, maternal and infant infections, COVID-19 and influenza. 

Within the Global Evidence Generation Platform, a dedicated team of RWE Scientists reporting to the Vaccines RWE Lead support the Vaccines TA, including inline programs, pipeline programs, the mRNA platform, and other special projects. The Director, Vaccines RWE Scientist will lead RWE delivery of rapid feasibility assessments, real world insights (RWI) and easy-to-understand summary reports for the COVID-19 vaccine, by understanding pipeline / asset teams’ objectives and timelines. They will co-develop RWE protocols in collaboration with the cross-functional asset teams and RWE Biostatistics to demonstrate and enhance value generation for the COVID-19 vaccine. The Director, Vaccines RWE Scientist will provide guidance on the most appropriate types of data, datasets, and methodology for a given problem, and coordinate RWE project execution with appropriate internal and partner analytic resources and tools. They will ensure the development of consistent business rules, versioning rules as care pathways evolve, standards and procedures.

The Director, Vaccines RWE Scientist will work closely with the Vaccines RWE Lead and cross-functional teams on assets’ RWE strategy development. They will direct the RWE cross-functional teams’ work with COVID-19 vaccine pipeline / asset teams to integrate RWE into their strategic plans and will use these plans to identify key RWE teams’ external data partnership opportunities. They will oversee data procurement activities (e.g., landscape assessments and due diligence or supporting contract development for external studies). They will act as a subject matter expert in RWE studies and lead projects independently. They will also have the opportunity to support other non-COVID-19 vaccines  and to mentor / advise other RWE Scientists.

ROLE RESPONSIBILITIES

• Act as the RWE subject matter expert for the Vaccines franchise, with a focus on COVID-19 and similar respiratory pathogens.

• Communicate and advocate effectively throughout the organization to support the appropriate use of RWE.

• Educate colleagues throughout the organization on RWE enabled use cases and best practices.

• Work collaboratively to ensure high quality methods and designs throughout the product lifecycle (early clinical development through loss of exclusivity)

• Conduct feasibility assessments to determine appropriate internal / external real-world data sources

• Create real world insights informing go/no-go decisions, hypothesis generation, and decision-making for executives, teams, and business development

• Coordinate cross-functional teams to create high quality RWE on COVID-19 from rigorously designed protocols

• Create TA-specific RWE assessment plans and recommend RWE analytical approaches

• Proactively identify opportunities for automation, collaboration, and innovation

• Drive landscape assessments and evaluations of new data / tools.

• Track market trends and regulatory standards.

• Document all requests and track progress toward project completion, other metrics, and business goals.

BASIC QUALIFICATIONS

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop, and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• 8+ (with a Master’s degree) years of experience with a proven successful track record of scientific analysis and publication for observational/non-interventional studies, RWE generation, with specific experience with a range of real world data such as EHR, medical or pharmacy claims, patient registries, or other data sources

• Five or more years working in real world data analytics in healthcare, clinical or translational research, pharmaceutical Research & Development, or similar.

• Ability to critically evaluate analytic results against the literature, subject matter expert feedback or other reliable sources to ensure end user credibility in alignment with cross-functional team strategy / priorities

• Strong experience communicating in verbal and written form with all levels of personnel with diverse backgrounds

• Ability to work under pressure with a high level of autonomy and motivation

• Experience in COVID-19, other vaccines, mRNA or the interest and ability to rapidly learn these domains to understand and proactively apply the latest scientific findings for projects

• Experience with protocol development and execution for non-interventional studies using a variety of analytical techniques applied to various databases

• Mentorship and leadership skills, particularly in highly matrixed organizations.

• Knowledge of query and analytic languages and technologies (eg, SQL, R, Python, SAS, IHD, Aetion) and of relevant biological and medical data standards (eg, HGNC / Entrez, ICD, CPT)

PREFERRED QUALIFICATIONS

• Master’s degree or higher in epidemiology/pharmacoepidemiology, RWE analytics, Statistics, Economics, Bioinformatics, Other Biological Science fields with a substantial quantitative and computational component, other related fields or commensurate professional experience, with extensive experience working on COVID-19 and similar pathogens

• Knowledge of vaccines development, infectious disease, host/pathogen interactions, immunology, clinicogenomics, GWAS / PheGWAS dataset interpretation, mRNA and other Vaccines-relevant experience highly desired

• Ability to communicate effectively with cross-functional teams and work in a highly matrixed environment, with demonstrated excellence in teamwork and collaboration highly desired

• Significant experience in four or more of the following:

• Experience in clinical registry, patient generated health data, unstructured clinical data and other health data sources.

• Understanding global regulatory guidance for appropriate use and submission of RWE.

• Knowledge of global HTAs’ / payers’ RWE acceptance, and experience in value-based agreements, value-based care and similar constructs.

• Knowledge of efficient programming practices and the software development life cycle

• Experience engaging or partnering with external organizations (e.g., IDN, ACOs, payers, academic institutes, professional organizations, etc.) for RWE.

• Artificial Intelligence (AI) / Machine Learning (ML): ability and experience in creating advanced models to generate real world insights.

• Data Visualization: passion for and experience in generating easy-to-use, interactive data visualization capabilities (e.g., Tableau, PowerBI, Qlik, Spotfire, Looker).

• Clinicogenomics: understand the clinical application of genomic, transcriptomic and other biomarker tests and result reports as they pertain to clinical care or research.

• Experience integrating real world evidence in early clinical development.

• Experience using RWE to drive value-based care, generally, and value-based contracting, specifically.

• Knowledge of US 21st Century Cures Act as it pertains to the inclusion of Real World Evidence into the FDA drug approval process

• Analytical consulting within life sciences/biopharmaceuticals industry

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

OTHER JOB DETAILS

• Last Date to Apply for Job: June 8, 2023 

The annual base salary for this position ranges from $156,900.00 to $261,500.00. In addition, this position offers an annual bonus with a target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

Relocation assistance may be available based on business needs and/or eligibility.

Market Access

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