Research Scientist I, MID

Job Summary: Contribute and support to the MID group in all phases of clinical, regulatory development and medical writing projects. The Research Scientist will be responsible for supporting the development of services that achieve the objectives of a customer’s clinical development program mostly with focus on clinical pharmacology aspects.

What You'll Do:

• Assist in the development of models and services to fulfill client objectives with the highest standards of
• quality and innovation and/or act as a support resource in the clinical pharmacology or regulatory science
• area of expertise (e.g., Pharmacokinetics. Pharmacodynamics, Safety, Biopharmaceutics, etc.)
• Collaborate with project teams and assist with a broad spectrum of Regulatory, Development and Consulting projects:
  • Research: assist with development of background information for assigned projects
  • Writing: with direct supervision, assist in the writing and editing of regulatory and/or scientific documents such as protocols, clinical study reports, Investigator Brochures, briefing documents, etc.
  • Implementation: assist in the production and finalization of quality deliverables on time and on budget
• Assist in the interaction with clients to understand their objectives and meet their needs (i.e., pre-clinical
• and clinical as well as the regulatory client representatives).
• Assist in preparing information at internal or external meetings
• Interact and collaborate effectively with multidisciplinary departments
• Rely on instructions and pre-established guidelines to perform functions of the job under supervision
• Assist in the development and presentation of educational materials for staff
• Develop and maintain knowledge and expertise through ongoing awareness of updates to industry practices, and participation in professional activities

What You'll Bring:

• Master’s or Bachelor’s Degree in Pharmacokinetics/Pharmacodynamics (PK/PD), Pharmacometrics, Pharmacology, or a related field.
• 0 - 2 years of relevant experience in the pharmaceutical or biotechnology industry. Relevant experience can include internships, academic research, or industry positions related to pharmacometrics.
• Basic knowledge of software such as NONMEM, Monolix, Phoenix NLME, R, MATLAB, and other relevant modeling and simulation tools.
• Basic understanding of regulatory requirements and guidelines (e.g., FDA, EMA) related to pharmacometrics preferred.
• Experience contributing to regulatory submissions preferred.
• Understanding of population PK and/or PK/PD modeling, exposure-response modeling, and clinical trial simulation preferred.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process