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Research And Development Scientist

2 months ago

Minneapolis, United States Humanetics Corporation Full time

This is an exciting opportunity to join a strong and entrepreneurial team with an ability to have an immediate impact on the development of new pharmaceutical drugs.  You will become exposed to all aspects of early and late stage drug development including pharmacology, toxicology, clinical studies, regulatory affairs and chemistry, manufacturing and controls.


Humanetics is a privately held, clinical-stage pharmaceutical company engaged in the discovery and development of proprietary pharmaceutical candidates.  The Company is currently focused on the development of its leading drug candidate BIO 300 as a first-in-class medical countermeasure with applications in biodefense, oncology and inflammatory diseases. 


Position Overview: This is a cross-disciplinary position that will be responsible for the development, execution and management of research and development (R&D) activities for indications in biodefense. This position involves R&D project management and does not directly involve hands-on benchwork. Position will work directly with the Program Manager to oversee nonclinical studies, clinical trials and manufacturing R&D activities. Additional responsibilities include drafting and submission of government grants and contracts and providing support for regulatory submissions. This position is of immediate need and will be integrated into the Company’s cross-functional government contract team. Position reports to the Program Manager for Medical Countermeasures.


Position Responsibilities:

  • Manage and coordinate research activities with external contract partners and academic collaborators.
  • Maintain project documentation including meeting agendas, minutes, timelines, and presentations.
  • Conduct nonclinical and clinical data analyses (pharmacokinetic, pharmacodynamic, efficacy, safety, analytical)
  • Provide written and oral communication of project status, goals and milestones to senior management.
  • Provide written scientific or technical content for nonclinical and clinical research protocols and study reports.
  • Participate in intellectual property evaluations and submission of patent applications.
  • Participate in the writing and submission of scientific articles to peer-reviewed journals.
  • Submission of abstracts to scientific conferences and representation of the Company at scientific conferences. 
  • Prepare and submit grant and contract proposals to government agencies and other appropriate organizations.
  • Support written communications with government agencies, including NIH, DOD, and FDA.
  • Ensure that all R&D activities are compliant with current regulatory and quality guidelines (FDA, GMP, ICH, etc.).


Basic Qualifications:

BS/MS degree in Pharmacology, Molecular Biology, Physiology, Chemistry, Biochemistry or related scientific field.

  • Relevant experience: 5 years with BS degree or 3 years with MS degree.
  • Experience designing, managing or supporting clinical research
  • Ability to problem solve and demonstrated proficiency in written and verbal communication. 
  • Ability to manage a wide range of project activities and a willingness to accept new responsibilities.


Desired/Preferred Qualifications:

PhD in one of the disciplines listed above and 0-2+ years of experience, including:

  • Experience managing early or late phase clinical trials and/or analyzing clinical data.
  • Experience conducting research using animal models of radiation response
  • Experience conducting pharmacokinetic or toxicology studies in animal models
  • Bioinformatics, biostatistics or related experience
  • Experience in drug formulation development and analysis of pharmacodynamic/biomarker data.
  • Experience in commercial drug development and knowledge of FDA regulations governing drug approval.
  • Demonstrated track record in preparing and obtaining external research and development grants and/or contracts.


Salary/Benefits/Other:

  • High visibility/high impact position.
  • Salary commensurate with experience and expertise.
  • Participation in annual bonus and restricted stock programs.
  • 401(k) program.
  • Health and dental insurance.
  • Hybrid work.
  • Limited travel.