Disease State Scientist

1 Month ago • 3 Years + • Research Development

Job Summary

Job Description

The Disease State Scientist is responsible for setting the clinical research agenda by organizing evidence needs into a strategic plan. This role involves formulating clinical research questions, identifying experimental design approaches, and creating actionable plans to generate evidence. The scientist will design and review clinical studies, interpret data, and prepare manuscripts. Key activities include providing medical and scientific guidance, collaborating with cross-functional teams like Clinical Research Scientists, Biostatistics/Data Management, Data Managers, and Medical Writers to generate clinical evidence supporting the company's evidence strategy. The position also requires staying updated on scientific advancements and regulatory changes, maintaining expertise in the scientific and research landscape, and evaluating pathways for evidence generation. Responsibilities include leading study synopsis development, protocol refinement, and reviewing Investigator-Initiated Research proposals, establishing study evaluation frameworks, conducting medical literature reviews, engaging with external stakeholders, and cultivating a global network of Key Opinion Leaders (KOLs).
Must have:
  • PhD in a scientific discipline
  • 3+ years of experience in medical affairs or clinical development
  • Proven record of advancing science through evidence generation
  • Experience in Clinical research and KOL engagement
  • Ability to generate clinical research questions and design studies
  • Publish results in peer-reviewed journals
  • Strong communication of complex scientific information
  • Ability to present research findings
  • Ability to evaluate evidence and identify biases
Good to have:
  • Lead authorship of peer-reviewed publications

Job Details

The Disease State Scientist plays a pivotal role in helping to set the clinical research agenda. This role will take the lead on organizing evidence needs into a strategic plan and requires the proven ability to drive clinical research to its completion. This includes the ability to formulate a clinical research question, identify a range of possible experimental design approaches for answering that research question, and then work with other team members to generate an actionable plan to execute on the generation of the evidence. As a key medical and scientific leader, activities will include the design and review clinical studies in coordination with other team members, as well as ensuring effective planning within your area of expertise. In addition, this role will aid in the interpretation of study data and results as well as the preparation of manuscripts and other associated materials. 

The position plays a central role in the generation of the clinical and patient outcomes evidence that demonstrates the medical value of our solutions. 

You will provide medical and scientific guidance to the team executing the non-registrational study program, ensuring alignment with established standards. The Global Medical Scientist collaborates closely with cross-functional teams, including Clinical Research Scientists, Biostatistics/Data Management, Data Managers, and Medical Writers to generate impactful clinical evidence that supports the company's evidence strategy. This role is crucial in our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape. 

Additionally, you will stay informed about the latest scientific advancements and regulatory changes, ensuring our clinical evidence generation remains innovative and relevant.  

This position can also be located in St. Louis OR Salt Lake City.

 

Primary Duties:
  1. Maintain deep expertise in the scientific and research landscape within the designated area of focus, ensuring continuous advancement in knowledge. 
  2. Strategically define and articulate evidence needs through collaborative engagement, aligning with clinical and business objectives. 
  3. Critically evaluate and determine the most effective pathways and methodologies for robust evidence generation. 
  4. Lead the development and refinement of company-sponsored and collaborative study synopses and collaborates on protocol development while conducting thorough reviews of Investigator-Initiated Research (IIR) proposals. 
  5. Establish and oversee a systematic study evaluation and selection framework, ensuring effective governance and portfolio optimization. 
  6. Conduct comprehensive medical literature reviews, maintaining a cutting-edge understanding of key therapeutic areas. 
  7. Serve as a distinguished subject matter expert, engaging with external stakeholders at various management levels to guide study operations and optimize research scheduling. 
  8. Cultivate and sustain a global network of Key Opinion Leaders (KOLs) and Investigators, fostering meaningful clinical research collaborations. 
  9. Provide authoritative medical guidance to cross-functional teams, including biostatistics/data management, R&D, regulatory affairs, and marketing, driving strategic decision-making. 

 

Education and Experience Required:

  1. PhD in a scientific discipline
  2. 3+ years of relevant experience in medical affairs, clinical development, or a related function which can include the following:
    1. Candidate should have a proven record of advancing science through evidence generation 
    2. Experience in Clinical research, including KOL (Key Opinion Leader) engagement 
    3. Proven experience in generating clinical research questions, translating these questions into viable study designs and then publishing the results of these studies in peer reviewed journals 
    4. Lead authorship of peer-The original job posting does not contain any information regarding the application deadline. Therefore, the value is null.
 
Knowledge, Skills & Abilities

      1. Strong ability to communicate complex scientific information clearly and concisely, both in         writing and verbally. 

  1. Ability to present research findings effectively to both scientific and non-scientific audiences. 
  2. Ability to evaluate evidence, identify biases, and draw valid conclusions. 

#LI-US

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