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Principal Scientific Advisor

Bedford, MA

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Our client is seeking a Remote Principal Scientific Advisor!

Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training, and promotes a teamwork-driven environment.

The Principal Scientific Advisor will focus in offering scientific guidance within project teams and across functional areas across the Safety Assessment group, but with an emphasis on providing scientific and innovative advice on nonclinical (pharmacology and toxicology) drug development programs.

Specific Responsibilities:

  • Ensures that clients’ business and scientific needs are understood and efficiently addressed
  • Works Client-facing to design nonclinical drug development programs
  • Performs gap analyses, supports due diligence procedures, and performs scientific review of discovery and/or safety assessment data or reports
  • Is recognized throughout the company as a subject matter expert in one or more therapeutic area(s) or for particular class(es) of therapeutic products, emphasis on cell/gene therapy and oligonucleotides (SiRNA, mRNA, ASOs)
  • Has thorough knowledge of domestic and international regulatory expectations and requirements
  • Provides intellectual input in determining the appropriate discovery strategy for complex and novel products including gene and cell therapies

Qualifications:

  • Master’s degree or Ph.D. in a relevant field (pharmacology, biology, immunology, toxicology, etc.)
  • Experience in developing nonclinical safety assessment programs for advanced and novel programs such as oligonucleotides, advanced medicines (gene and cell therapies) and may include viral and nonviral delivery products.
  • 10+ years of experience in the pharmaceutical or biotech sector
  • 5+ years of experience in nonclinical drug development
  • Understanding of regulatory requirements for the conduct of nonclinical studies
  • Understanding of regulatory GLP studies
  • Demonstrated leadership skills