Sr. Scientist, CRO/Data Management

Location
Redwood City, CA
Posted
Jul 29, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Adverum is a clinical stage gene therapy company targeting unmet medical needs in ocular and rare diseases. Adverum is seeking a scientist to perform preclinical development activities (pharmacology and toxicology studies) for IND-enablement of gene therapy products and authoring study reports for regulatory submissions. Must possess skills with the ability to work independently in a dynamic and cross-functional company. Exceptional writing and strong communication skills are required. Given that this is a highly innovative field of drug development and that the regulatory and scientific landscape is evolving, this individual will be required to follow the literature on nonclinical development in the field of gene therapy.  
What You'll Do:
  • Contribute to design and manage preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions.
  • In coordination with the senior preclinical monitor supervise and conduct preclinical studies with CROs, ensure study compliance and propose mitigations if necessary.
  • Closely collaborate with research and analytical development teams on data analysis and interpretation.
  • Write and edit preclinical study protocols and study reports.
  • Prepare and edit non-clinical documents for regulatory submission.
  • Work closely with other functional areas and colleagues to ensure that all studies are performed in a high quality, timely and scientific manner.
  • Collaborate with project team members on development strategy.
  • Oversee outsourced bioanalytical studies to warrant the quality and data transfer generated by the CROs and compliance with internal and regulatory requirements.
  • Oversee and optimize sample and data flow and processing.
  • Contribute to manuscripts on safety, pharmacology, and efficacy in relevant animal models to support product development.

About You:
  • Ph.D. degree with the experience in gene therapy, ophthalmology, age-related diseases, neurodegeneration, inflammation or a related field with 3+ years of industrial experience or 7-8+ years of postdoctoral experience, working in one of these fields. Has excellent publishing record in peer-reviewed journals.
  • Demonstrated ability to independently propose, design, execute, and report research projects, conducted internally and externally.
  • Experience in preparation and editing of non-clinical study reports for regulatory submissions. Academic scientist with experience in contributing to regulatory submissions.
  • Occasional travel to the CROs may be required (less than 10% of time).
  • Prior experience of working at CROs or with CROs as a sponsor representative is a plus

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation