Associate Director, Quantitative Pharmacology Position Available In Middlesex, Massachusetts

Job Description:

Company Overview:

Dyne Therapeutics is discovering and advancinginnovative life-transforming therapeutics for people living withgenetically driven neuromuscular diseases. Leveraging themodularity of its FORCE™ platform, Dyne is developing targetedtherapeutics that deliver to muscle and the central nervous system(CNS). Dyne has a broad pipeline for neuromuscular diseases,including clinical programs for myotonic dystrophy type 1 (DM1) andDuchenne muscular dystrophy (DMD) and preclinical programs forfacioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Role Summary:

The Associate Director, Quantitative Pharmacology andModeling & Simulation (M&S) is responsible for providingstrategies, plans and deliverables on pharmacology and relatedquantitative analytics, for the advancement of programs across allstages of drug development at Dyne Therapeutics. Primaryresponsibilities include the strategic planning and execution ofpharmacology- and biomarker-related modeling & simulation (M&S)activities in seamless coordination and collaboration with otherinternal functions and subject matter experts (SMEs), and thefurther implementation of an internal quantitative data analytics &modeling infrastructure in coordination with internal and externalfunctional partners. The person in this role applies quantitativemodeling, including pharmacometrics, modeling based on firstprinciples (mechanistic PKPD, QSP, PBPK, etc), and data miningapproaches, in support of objectives and progression of drugdevelopment programs, from preclinical inception to drug regulatoryregistration and approval. The person in this role works seamlesslywith colleagues in the Translational Biomarkers & Pharmacologydepartment and, with SMEs in platform discovery, preclinicalresearch, clinical development, clinical operations, regulatory,CMC and program management, enabling IND submissions, initiation ofclinical development programs, late-stage development, andinteractions with Health Authorities. This role is based inWaltham, MA without the possibility of being a remote role.

PrimaryResponsibilities Include:

Provide strategies and plans forquantitative data analytics (pharmacometrics, population PK/PDanalyses, mechanistic drug-disease modeling, meta-analyses, datamining), in alignment with Regulatory requirements as well ascorporate and R D goals, thereby enabling the advancement ofDyne programs across all stages of drug development Provideexpertise and guidance on quantitative aspects, including dosingstrategies and PK/PD, to R D program teams working alongsidewith Clinical Pharmacology and Biomarker Leads and in closecollaboration with Medical, Biometrics, Pharmacovigilance,Preclinical Tox and

ADME/DMPK

SMEs. Provide hands-on quantitativedata analyses, including PK/PD modeling and related tools, insupport of program pipeline progression, from preclinical toclinical, and from early to late clinical development Lead thedepartment in establishing a fit-for-purpose, internal PK/PDmodeling workflow environment, from data inception to modelbuilding, model qualifying and model simulations, to enable PK/PDanalyses internally while also interfacing with external modelingCROs Identify and manage consultants and vendors to support M&Sactivities Author high quality regulatory documents Accountable foradherence to agreed timelines and budgets to ensure execution ofdeliverables from Clinical Pharmacology studies and programsCollaborate cross functionally with all relevant areas to supportcorporate objectives

Education and Skills Requirements:

PhD,PharmD, or equivalent training in Quantitative Pharmacology,Pharmaceutical Sciences, Engineering, Physics, Applied Mathematics,and/or Computational Sciences, with 8 years of bio/pharmaceuticalindustry drug development experience in Pharmacology- orBiomarker-related functions Strong understanding of ClinicalPharmacology principles, PK/PD modeling and simulation, the drugdevelopment process and regulatory guidance, particularly aroundoligonucleotides and biologics (including antibody-drugconjugates), molecular delivery systems, and rare diseases Hands-onskills in M&S and related infrastructure tools, including R,Monolix (or NONMEM), WinNonLin, data exploration & mining tools;experience in model-based meta-analyses desirable Experience withthe preparation of Clinical Pharmacology portions of regulatorydocuments such as pre-IND, IND, IB, briefing documents, clinicalstudy reports, CTA, and BLA Ability to devise innovative dosingstrategies in a data-driven manner for novel classes of drugmodalities Strong interpersonal and relationship building skillswith demonstrated experience to lead and influence within amatrixed environment Ability to work and communicate in an open andclear manner, listening effectively and inviting responses anddiscussions with internal and external partners Independent andhighly motivated, with the ability to multi-task, drive strategyand execution, in a fast-paced and fluid collaborative environmentLI-Onsite The statements contained herein reflect general detailsas necessary to describe the principles functions for this job, thelevel of knowledge and skill typically required, and the scope ofresponsibility, but should not be considered an all-inclusivelisting of work requirements. Individuals may perform other dutiesas assigned, including work in other functional areas to coverabsences or relief, to equalize peak work periods or otherwisebalance workload. This description is not intended to beconstructed as an exhaustive list of duties, responsibilities, orrequirements for the position. This position may change or assumeadditional duties at any time. The employee may be requested toperform different or additional duties as assigned. All Employeesare expected to adhere to all company policies and act as a rolemodel for company values. Dyne Therapeutics is an equal opportunityemployer and will not discriminate against any employee orapplicant on the basis of age, color, disability, gender, nationalorigin, race, religion, sexual orientation, veteran status, or anyclassification protected by federal, state, or local law.