Director Clinical Pharmacology
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.
The position will be reporting to the Executive Director, Clinical Pharmacology. In this position, s/he is expected to provide technical leadership in clinical pharmacology and pharmacometrics and work closely with colleagues across functional areas in collaboration with non-clinical development and multidisciplinary program strategy teams. This role requires strong strategic thinking, excellent communication skills, time management skills, in-depth PK/PD and clinical pharmacology knowledge, and application of model informed drug development (MIDD) approaches.Essential Duties and Responsibilities
- Develop regulatory clinical pharmacology, MIDD strategy, and optimization of dosing regimen for assigned programs from FIH to Phase III.
- Lead study design, execution and reporting of clinical pharmacology studies and pharmacometrics analyses and reports.
- Oversee relevant data analyses: non-compartmental PK, PK/PD analyses, population PK and PK/PD, and other modeling and simulation activities as appropriate for the project.
- Develop high quality clinical pharmacology and pharmacometrics plans and content for protocols, CSRs, global regulatory submissions, including INDs, CTAs, IBs, NDAs, MAAs and
- Collaborate with discovery research teams and non-clinical toxicology group in planning of non-clinical studies.
- Provide input to overall product development strategy including biomarker development, design of natural history studies, clinical development plans, pediatric plans, and regulatory strategy.
- Doctorate degree in pharmacology, pharmacokinetics, pharmacometrics or related field.
- At least 10 years of clinical pharmacology and pharmacometrics experience in pharmaceutical industry or regulatory agency.
- In-depth knowledge of clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
- Good understanding of PK/PD modeling and analysis tools like R, Phoenix, NONMEM, Monolix
- Demonstrated experience writing clinical pharmacology and pharmacometrics sections of IND, CTA, NDA/MAA and interacting with regulatory agencies.
- Ability to proactively identify issues and solve problems.
- Previous experience successfully working in a clinical development team/matrix team.
- Prior experience in mAb and oligonucleotides development is desirable.