Sr. Manager, Preclinical Development (External Studies)

Bothell, WA

The Company:

AVI BioPharma is a drug development and commercialization company focused on novel RNA therapeutic drugs in two classes with clinical programs in Duchenne muscular dystrophy, a range of viral diseases including Ebola, Marburg, Junin and Dengue viruses and, through a partnership with Cook Medical, in the prevention of restenosis in patients receiving a drug-eluting arterial stent after angioplasty for arterial occlusion.  AVI BioPharma has pioneered the Phosphorodiamidate Morpholino Oligomer (PMO) with second generation chemistries of the Peptide conjugated PMO (PPMO) and the PMOplus which work by two different mechanisms: Translation Suppressing Oligomers (TSO - like the traditional antisense), and Splice Switching Oligomers (SSOs).

The Position:

AVI is currently seeking an experienced toxicologist/pharmacologist to oversee external preclinical study collaborations.

Job Description:

The candidate will oversee the design and implementation of formal (e.g., GLP) non-clinical studies to be conducted by commercial laboratories to support product development.  Experience is essential in toxicology and pharmacology, to support Clinical Development programs and regulatory filings. Additional responsibilities include: evaluation of facilities and methods to ensure suitability; analysis and interpretation of the results. The individual may also be expected to present data via publications.

Primary responsibilities include:

  • For all non-clinical programs:
    • Point of contact for collaborations/CROs in support of development teams and clinical and regulatory affairs
    • Implement appropriate Preclinical Development Plans
    • Preclinical toxicology support to Clinical Development and Regulatory teams (including budgeting, timing and reporting of all preclinical studies)
    • Ensure all completed reports are of high quality and on time
    • Ensure appropriate data interpretations
    • Prepare and submit abstracts and support development of manuscripts

 Education and Skills Requirements: 

  • Ph.D. or M.D./Ph.D. (or M.S. with 5+ years experience), preferably in Toxicology and/or Pharmacology.
  • A minimum of three years in preclinical development with emphasis in toxicology. Experience with design, conduct and interpretation of toxicity studies. Experience in NDA & IND applications. Experience in a research field related to Preclinical Development, Toxicology, and Preclinical Pharmacology.
  • Familiarity with GLP requirements and ICH guidelines, experienced in management of external academic collaborations and CROs. Proficient in scientific documentation supporting submissions to regulatory agencies. Experience on the design, conduct, analysis and interpretation of non-clinical studies. Training in Animal Use Protocols as PI, or sponsor.
  • An excellent scientific/clinical background as demonstrated through publications in basic medical science journals. Experience with designing, conducting, analyzing and interpreting non-clinical studies.
  • Proficient in various computer programs such as Win-Nonlin, Word, Powerpoint, and Excel
  • Able to manage/advance programs: 1) alone, as a team member or leader; 2) with consultants, and outside collaborators; 3) CROs with demonstrated success.
  • Proven ability to build productive relationships within internal or external teams

AVI offers a competitive compensation and benefit package.

AVI participates in e-Verify.

AVI is an Equal Opportunity/Affirmative Action employer.

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