Description

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

In this position, s/he is responsible for clinical pharmacology and pharmacometrics deliverables for assigned clinical programs. You will be expected to be a strategic leader that uses novel MIDD approaches and clinical pharmacology principles to aid in clinical trial designs and dose selection. You will also be expected to lead overall clinical pharmacology strategy and provide input to overall clinical development plans, pediatric plans, and regulatory strategy. This role requires strong quantitative skills, excellent communication and time management skills, and in-depth knowledge of model informed drug development (MIDD) approaches.

Responsibilities include:

• With guidance, develop MIDD and clinical pharmacology strategy for assigned clinical programs from FIH to Phase III.
• Independently derive non-compartmental PK and conduct PK/PD data analyses through software tools; interpret and report to project teams.
• Accountable for planning and execution of clinical pharmacology and pharmacometrics analyses.

• Independently author dose justification, clinical pharmacology content for protocols, CSRs, global regulatory submissions, including INDs, CTAs, IBs, BLAs, MAAs and pediatric plans.

• As necessary, collaborate with Clinical, Regulatory, Biometrics, Bioanalytical, DMPK, and others in planning and execution of clinical studies.

Qualifications:

• Doctorate degree in pharmacology, pharmacokinetics, pharmacometrics or related field; PharmD with appropriate post-doctoral experience.
• At least 4 years of clinical pharmacology and pharmacometrics experience in pharmaceutical
  industry or regulatory agency.
• Strong hands-on skills in R for data analysis.
• Hands on experience in PK/PD/disease progression modeling in relevant softwares and able to simulate from PK/PD models to aid in decision making.
• Knowledge of Health Authority perspective on utility of clinical pharmacology/modeling in clinical decision making.
• Prior experience in building PBPK models for mAb and/or oligonucleotides is desirable.