AD Clinical Pharmacology Pharmcometrics

 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.

In this position, s/he is responsible for clinical pharmacology and pharmacometrics deliverables for assigned clinical programs. You will be expected to be strategic hands-on modeler using mechanistic and/or statistical models to understand PK/PD relationships and disease-drug interactions to aid in 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 programs from FIH to Phase III.
• Independently conduct non-compartmental PK, exposure-response analyses, population PK and PK/PD, and other modeling and simulation activities as appropriate for the project.
• Accountable for timely execution and reporting of clinical pharmacology studies and pharmacometrics analyses and reports for assigned projects.

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

• As necessary, collaborate with Clinical, Regulatory, Biometrics, Bioanalytical, DMPK, and others in planning and execution of clinical studies.
• Contribute to clinical pharmacology and pharmacometrics infrastructure.  
• As required, manage modeling and clinical pharmacology CROs in planning and timely execution of program deliverables.

Qualifications:

• Doctorate degree in pharmacology, pharmacokinetics, pharmacometrics or related field.
• At least 5 years of clinical pharmacology and pharmacometrics experience in pharmaceutical
  industry or regulatory agency.
• Strong hands-on skills in R and PK/PD modeling skills in Phoenix, NONMEM, Monolix or others
• 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.