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.
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
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.