Principal Scientist, Toxicology
Description
Principal Scientist*– Toxicology, Development Sciences
*Title is open to be commensurate with relevant experience
Job Description
Avidity Biosciences is looking for an experienced scientist with a strong research background
and drug development experience with proven ability to plan and execute nonclinical
development strategy to advance programs from research to early and late clinical
development. Ability to collaborate with multidisciplinary teams to understand the
pharmacologic/toxicologic mechanism(s) of drug-induced responses is a key attribute. The best
candidate for this position has the ability to understand complex biologic pathways across
multiple programs and identify key preclinical research knowledge gaps to best inform the
pharmacology and safety profile of drug candidates.
Responsibilities
• Key contributor on multidisciplinary research and development teams to represent the
toxicology function to define and implement nonclinical safety strategy for novel candidate
molecules.
• Lead the evaluation of potential safety and toxicity liabilities of biologic pathways of
interest.
• Lead the regulatory toxicology strategy with design and conduct of experiments to help
inform the potential translatability and relevance of nonclinical safety findings to humans
and comply with ICH guidelines.
• Manage nonclinical development studies for pre-candidate and early and late
development programs in-house and at contract research organizations.
• Closely partner with Research Project Team leaders, Clinical pharmacology and Biomarkers
in the design and interpretation of nonclinical pharmacology and efficacy studies as they
relate to assessment of PKPD and human dose projection.
• Closely partner with Regulatory Affairs and Clinical Development to support key clinical
and regulatory milestones from candidate selection through marketing authorization.
• Responsible to draft and review nonclinical sections of regulatory documents (IND, IMPD,
CTA, IB, briefing packages) including nonclinical pharmacology, pharmacokinetics, and
toxicology.
• Ability to participate and present at health authority meetings.
• Ability to convey data and strategies clearly and concisely in slides presentations and oral
presentations (internal and external).
Salary Range: $170,000 - $190,000
Required Experience
• 8+ years of experience in the biotech/pharmaceutical industry in the area of nonclinical
drug discovery and development.
• PhD degree in toxicology, pathology, pharmacology, or related discipline
• Post-doctoral experience preferred.
• DABT certification preferred.
• Experience with RNAi therapeutics, monoclonal antibody therapeutics and conjugated
molecule therapeutics preferred.
• Experience with Investigational toxicology (in vitro and in vivo) and secondary off-target
pharmacology preferred.
• Excellent interpersonal skills, ability to work in a matrix environment and develop
relationships with key stakeholders.
• Excellent communication and presentation skills to efficiently relay information to project
teams, senior management team and with other key stakeholders.
• Proven ability to be responsible for multiple programs at various stages of drug
development.
• Proven ability to work independently and be self-motivated.