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Chief Scientific Officer - Real World Evidence

Lumanity
Yardley, PA
  • Expired: September 29, 2022. Applications are no longer accepted.
About Lumanity

Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence.

The Opportunity

In 2022 Lumanity launched its Real World Evidence (RWE) business, the fourth global practice in the Lumanity portfolio. Our offerings focus on value demonstration to payers and regulators, first in the US and Europe, and ultimately, as an offering to meet Pharma client needs globally. Initial use cases center on health economics and outcomes research (HEOR) and safety/pharmacoepidemiology, and will expand into use cases in the Pharma Research & Development (R&D) arena.

Market context:
  • Real world evidence is uniquely central to biopharma and medical device clients in the US and beyond for successful strategic planning, value demonstration, pricing, reimbursement, and market access, as well as safety/ pharmacoepidemiological monitoring and reporting.
  • Importantly, RWD/RWE strategies and research are applied throughout a product's life cycle beginning with early and late-stage development, to product launch and approval, and throughout the post-approval phase.
  • During early and late-stage product development, RWD/RWE informs market sizing, quantifying practice patterns, defining the patient journey, identifying the limitations and the costs of standard-of-care clinical pathways, and comparative effectiveness research. In this way, RWD/RWE are inherent to creating and substantiating a product's value proposition, value story, and HTA strategy.
  • Prior to and at the time of new product approval, RWD/RWE is utilized by manufacturers for formulary dossiers and scientific communications, and, to define and populate the "input parameters" and structure for budget impact and other economic models. In addition, RWE data are increasingly included in health technology assessment and reimbursement submissions; and, increasingly central to informing and executing value-based payment agreements.
  • Post-approval, RWD/RWE informs stand-alone research for product differentiation and value demonstration, and is critical for re-negotiations for formulary placement, access, and pricing.
  • While RWD can be broadly defined, for purposes of this role it is prioritized and specific to de-identified, linked insurance claims (e.g., medical, pharmacy), lab and imaging, and Electronic Health Record (EHR) data. In 2022, availability and access to RWD is expanding in the US and EU. In the US, which is the initial priority for this role, data access exists from "historical" single-source vendors, and, increasingly via integrated multi-source customizable formats from emerging technology-driven suppliers
  • At Lumanity, we aim to be "Data Luminaries," serving clients' data needs on demand, and matching each unique client need to the right dataset over the right timeframe, and to the right, robust analysis plan specific to the research question and business case.

Primary Responsibilities

The CSO will lead the research and scientific efforts of the RWE organization, independently, but also importantly, in collaboration with scientific resources in the broader Lumanity organization. This role will be responsible for overseeing all aspects of the RWE organization's scientific endeavors, including developing new services (e.g., Pharmacoepi/Safety offerings), building/leading research/scientific team, and ensuring quality standards are met. It is anticipated that year one will focus heavily on establishing a US-based team and processes. If successful, in five years, this role will oversee a market leading RWE scientific/research team serving Pharma client needs across the pharma product lifecycle, as evidenced by publication of research, high levels of client satisfaction and staff satisfaction and business performance.
  • Developing, leading, and managing the team of RWE scientists, researchers and analysts in delivery of RWD/RWE projects for clients, with particular focus on pharmacoepidemiologic/safety, and secondarily HEOR
  • Implementing and maintaining core processes and best practices related to design, analysis, interpretation, documentation, quality-control, and reporting of RWD research
  • Ensuring appropriate strategic (directly and via direct report and project teams) considerations are integrated into project planning and execution so that deliverables are both robust and relevant
  • Informing and facilitating regular RWD/RWE external thought leadership using multiple channels
  • Serving as an expert advisor to internal leaders and team members for RWE training and for current and emerging RWD/RWE methods, application, and relevant external policy and regulatory topics
  • Contributing to the enterprise overall RWD/RWE and associated technology strategy, and ensuring RWD/RWE client needs are met via collaboration across enterprise teams

Targeted time allocation
  • Client Services (Billable time) - 30%
  • Serve as named strategic advisor for RWD/RWE client projects
  • Support and guide teams in delivery of projects to clients
  • Business Development & Thought Leadership- 30%
  • Leverage personal professional and Lumanity networks to yield new client relationships, requests for proposals, and partnerships
  • Maintain and Expand Lumanity as marker-leading technical experts and strategic advisors via participation in relevant RWE organizations and engagements.
  • Team Leadership & Enterprise Contribution- 40%
  • Develop, lead, and manage RWE scientific/delivery team, focused initially on the US, but soon expanding to Europe
  • Serve on relevant Lumanity leadership teams & participate in enterprise working groups, business initiatives and client engagements
  • Enable work across the RWE global practice and across enterprise practices.

Requirements
  • 15+ years of experience with relevant expertise in design, execution and reporting of RWD/RWE studies, either within academia, consultancy, and/or the life sciences industry
  • Successful track record in delivering a range of RWD analyses and communications for life sciences companies and/or for peer review publication, with preference for Pharmacoepi/Safety experience
  • Demonstrated experience developing and establishing an RWD/RWE research team, including processes and best practices,
  • Expert understanding track record of working (directly/indirectly) with leading claims and EHR datasets in the US, and ideally experience with EU and UK datasets
  • Established track-record of peer-review publication of RWD/RWE research
  • Proven success conducting research on development or new medical technologies across all phases of clinical development, and ideally, experience informing a range of decision problems and business cases, but ideally across pharmacoepi/safety and HEOR
  • PhD in relevant field or MS in relevant field combined with MD or PharmD

Benefits
  • Competitive salary (dependent on experience), performance-based bonus plan, and long-term incentives package
  • Generous Personal Time Off (PTO) benefits based on years of professional experience across previous roles
  • 401K with matching contributions, life insurance
  • Comprehensive medical and health benefits
  • Location: US or Europe (homeworker or office-based)


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Lumanity

Address

Yardley, PA
USA

Industry

Science

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