Associate Director Toxicology, Nonclinical Development

Location
San Diego, CA, United States
Posted
Dec 22, 2020
Ref
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Discipline
Science/R&D, Toxicology
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Company Overview

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Summary

Avidity Biosciences is looking for an experienced scientist with a strong research background and development experience with a proven ability to plan and execute a nonclinical development strategy to advance programs from research to early 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 immerse in the understanding of complex biologic pathways across multiple programs, and identify key preclinical research knowledge gaps to best inform the pharmacology and safety profile of drug candidates

Essential Duties and Responsibilities

  • Key member on multidisciplinary research and development teams to represent the toxicology function to define and implement nonclinical safety evaluation strategy for novel candidate molecules.
  • Lead the evaluation of potential safety and toxicity liabilities of biologic pathways of interest.
  • Lead the design and conduct of experiments to help inform the potential translatability and relevance of nonclinical safety findings to humans.
  • Manage nonclinical development studies in-house and at contract research organizations.
  • Closely partner with Research Project Team leaders in the design and interpretation of nonclinical pharmacology and efficacy studies as they relate to the assessment of PKPD and human dose projection.
  • Draft and review nonclinical sections of regulatory documents (IND, IMPD, CTA, IB, briefing packages) including nonclinical pharmacology, pharmacokinetics and toxicology.
  • Immerse in the understanding of complex biologic pathways and identify key research activities of importance
  • Represent the company with external vendors to manage budgets, timelines, monitoring, protocol design, reporting, and compliance
  • Implement organizational processes, identifying needs for additional resources, developing and implements standard operating procedures, providing training as needed, and ensuring adherence to company policies and quality requirements, as appropriate


Qualifications
  • PhD degree in toxicology, pathology, pharmacology, or related discipline; post-doctoral experience preferred
  • 5+ years of experience in the biotech/pharmaceutical industry in nonclinical drug discovery and development
  • 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
  • Experience with large molecule (monoclonal antibody) and/or oligonucleotide-based therapeutic modalities in drug discovery and development desired
  • Demonstrated experience as a company representative on out-sourced toxicology studies managing CRO selection, contracting, budgeting, evaluation, timelines, communication, monitoring, protocol design, study execution, reporting and regulatory compliance
  • Experience working in a regulated environment and knowledge of GLP regulations and relevant FDA, EMA, and ICH guidelines
  • Proven ability to work independently and be self-motivated