Preclinical Principal Scientist

Location
Menlo Park, California
Posted
Mar 08, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Adverum is a gene therapy company committed to discovering and developing novel medicines that can offer life-changing benefits to patients living with alpha-1 antitrypsin deficiency (A1AT), hereditary angioedema, Friedreich’s ataxia or wet age-related macular degeneration (wAMD) who currently have limited or burdensome treatment options. The successful candidate will perform preclinical development activities (pharmacology and toxicology) for IND-enablement of gene therapy products in addition to facilitating and executing preclinical development plans for future pipeline products. The candidate must possess integrity, proven systematic drug development thinking, exceptional writing and strong communication skills with the ability to work independently in a dynamic and cross-functional company. Position reports to the Vice President, Preclinical Development.

 Essential duties and responsibilities include but are not limited to the following:

  • Write and edit preclinical study reports
  • Work closely with the members of Preclinical Development to evaluate therapeutic candidates in normal and ocular diseased models
  • Design and manage preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacology, toxicology, and biodistribution/shedding studies
  • Monitor conduct of preclinical study with CROs
  • Write preclinical sections for preclinical submissions
  • Work closely with other functional areas and colleagues to insure that all studies are performed in a quality, timely and scientific manner
  • Collaborate with project team members on development strategy
  • Develop, and write, position papers on safety, pharmacology and mode of action to support product development
  • Develop safety-related issue mitigation or resolution plans and coordinate execution of the experimental plan as required
  • Prepare and edit non-clinical documents for regulatory submission (e.g. IBs, and regulatory briefing documents)
  • Maintains a current understanding of pharmacology and toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects
  • The Scientist will report directly to the Head ofPreclinical Development

 Position Requirements and Experience:

  • Ph.D. in Biological Sciences, Toxicology, Pharmacology
  • 6-8 years drug development experience, with minimum 3 years working in industrial pharmaceutical toxicology/safety assessment drug development
  • Proven experience in design, coordination, analysis and documentation of preclinical studies
  • Ability to synthesize and interpret diverse, multidisciplinary data sets
  • Extensive knowledge/understanding of pharmacology pathways and MoAs relating to the IND-enablement of biologic programs with preference given to gene therapy programs
  • Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in medical or scientific writing
  • The ability to work independently and to collaborate with a multi-disciplined group in a goal- and team- oriented setting is required
  • Proficiency with MS Office and common laboratory software (GraphPad Prism, etc.).