Job Description

The Disease State Scientist plays a central role in setting up the clinical research agenda to generate the clinical and patient outcomes evidence that demonstrates the medical value of our solutions. This role will take the lead on organizing evidence needs into a strategic plan and requires the proven ability to drive clinical research (primarily non-registrational studies) 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 of 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 Disease State 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.

Primary Duties

• Maintain deep expertise in the scientific and research landscape within the designated area of focus, ensuring continuous advancement in knowledge.
• Strategically define and articulate evidence needs through collaborative engagement, aligning with clinical and business objectives.
• Critically evaluate and determine the most effective pathways and methodologies for robust evidence generation.
• 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.
• Establish and oversee a systematic study evaluation and selection framework, ensuring effective governance and portfolio optimization.
• Conduct comprehensive medical literature reviews, maintaining a cutting-edge understanding of key therapeutic areas.
• Serve as a distinguished subject matter expert, engaging with external stakeholders at various management levels to guide study operations and optimize research scheduling.
• Cultivate and sustain a global network of Key Opinion Leaders (KOLs) and Investigators, fostering meaningful clinical research collaborations.
• Provide authoritative medical guidance to cross-functional teams, including biostatistics/data management, R&D, clinical affairs, regulatory affairs, market access, and marketing, driving strategic decision-making.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Experience

• PhD, PharmD, or MD in microbiology, infectious diseases, epidemiology, clinical/translational science or related field required
• 5+ years of professional related experience in medical affairs, clinical development, or a related function
  • Proven record of advancing science through evidence generation
  • Experience in clinical research, including KOL (Key Opinion Leader) engagement
  • Proven experience in generating clinical research questions, translating these questions into viable study designs and publishing the results of these studies in peer reviewed journals

Knowledge, Skills & Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Analyze data and make decisions/recommendations, using data to guide decision-making and provide suggestions for improvement.
• Effectively deal with ambiguity requiring adaptability, critical thinking, and proactive communication to navigate situations with limited details
• Planning objectives and strategies to achieve them within a set timeline
• Ability to influence others
• Priority setting that align with business objectives
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
  • Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently

The estimated salary range for this role is between $120,000 and $145,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. In addition, bioMérieux offers a competitive Total Rewards package that may include: · A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options · Company-Provided Life and Accidental Death Insurance · Short and Long-Term Disability Insurance · Retirement Plan including a generous non-discretionary employer contribution and employer match. · Adoption Assistance · Wellness Programs · Employee Assistance Program · Commuter Benefits · Various voluntary benefit offerings · Discount programs · Parental leaves

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