The Real World Evidence (RWE) Center of Excellence (CoE) 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 Rare Disease TA is responsible for creating and commercializing therapies for rare disorders. Cross-functional pipeline and asset teams create and deliver biologic medicines, small molecules and exploratory gene therapies.
Within the Global RWE CoE, a dedicated team of RWE experts will support the TA. Reporting to the Rare Disease RWE Lead, the Rare Disease, RWE Scientist Director will deliver timely feasibility assessments, real world insights (RWI) and easy-to-understand summary reports 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. The RWE Scientist Director will provide guidance on the most appropriate types of data and datasets 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 RWE Scientist Director will work closely with the Rare Disease RWE Lead and cross-functional teams on assets’ RWE strategy development. They will direct the RWE cross-functional teams’ work with 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 experience in RWE studies and take on projects independently. They will also have opportunity to mentor / advise other RWE Scientists, directing their work.
Act as the RWE subject matter expert for rare disease franchise.
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 from early clinical development to 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
Coordinates cross-functional teams to create high quality RWE from rigorously designed protocols
Proactively identify opportunities for automation and collaboration.
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
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.
7+ (with a master’s degree) to 9+ (Bachelor’s degree) years’ experience with a proven successful track record of scientific analysis for Non-Interventional Studies, other research studies or clinical quality improvement studies, 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 of experience 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
Five of more years of experience in 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 Rare Disease domains, 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
Five or more years of hands-on experience of query and analytic languages and technologies (eg, SQL, R, SAS, IHD, Aetion) and of relevant biological and medical data standards (eg, HGNC / Entrez, ICD, CPT)
The ideal candidate will have a Master’s degree with 9+ years/PhD with 7+ years in RWE analytics Economics, Bioinformatics, Epidemiology, Other Biological Science fields with a substantial quantitative and computational component, other related fields or commensurate professional experience
Experience with Hemophilia, Duchenne’s Muscular Dystrophy, growth hormone deficiency, rare cardiac conditions, or other Rare Disease priority areas highly desired
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 institute, professional organizations, etc.) for RWE activities is strongly
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.
Other Job Details:
Additional Location Information: New York, NY; Collegeville, PA; US - Remote