Principal Scientist, Research - Chicago, IL

Seeking a Principal Scientist, Research with an MS or PHD in life sciences related field and 3-7 years of experience in development and execution of preclinical and/or clinical studies to support product development and regulatory registrations.

Responsibilities:

  • Develop preclinical/clinical product development strategies to support global registration of drug, device and combination products

  • Develop custom study protocols to evaluate safety and efficacy of products

  • Direct contract labs on preclinical/clinical study execution

  • Summarize study findings and evaluate relevance to product development path

  • Review regulatory submission documents for messaging and technical accuracy

  • Serve a cross-functional member of R&D project teams

  • Monitor technology landscape to identify potential technology leads

Qualifications:

  • MS/PhD in biology, microbiology, pharmacology or life-sciences field, PhD preferred.

  • MS 5-7 years, Ph.D. 3-5 years of experience effectively managing internal and contract research laboratories in clinical and nonclinical studies. 

  • Familiarity with GLP/GCP requirements for nonclinical and clinical studies.

  • Demonstrated success in development and execution of preclinical and clinical studies to support product development and registrations, ANDA/NDA and/or 510-K/PMA/CE mark/international product approval pathways.

  • Familiarity with global drug and device development processes.

  • Experience in the development of antimicrobials or topical drug products is desirable.

  • Ability to travel domestically and internationally as needed (10%-15%).

  • Demonstrated leadership capability.

  • Excellent communication and interpersonal skills.

  • Organized, and self-motivated.

Ideal Candidate Details:

  • MS (with 5-7 years industry experience) or PhD (with 3-5 years industry experience) in biology, microbiology, pharmacology or life-sciences-related field, PhD or equivalent preferred

  • Demonstrated success in development and execution of preclinical and/or clinical studies to support product development and regulatory registrations.

  • Familiarity with global drug and/or device development processes

  • Experience working in an environment controlled by Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and/or Good Documentation Practice (GDP) requirements.

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