Dyne Therapeutics
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The Director, Drug Safety & Pharmacovigilance Scientist is responsible for monitoring drug safety, ensuring regulatory compliance, managing safety signals, and leading cross-functional teams at Dyne Therapeutics, focusing on innovative therapeutics for muscle diseases.
The Associate Director is responsible for strategies and execution of pharmacology data analytics and modeling for drug development at Dyne Therapeutics. This includes PK/PD modeling, collaboration across functions, and supporting regulatory submissions, while managing vendor interactions and leading a modeling workflow.
The Director of Procurement will manage sourcing and contract negotiations, establish a standard process, and improve overall procurement metrics. They will coordinate with internal stakeholders, oversee relationships with managed service providers, draft procurement policies, and provide training.
The VP Program Team Leader will oversee the development of innovative therapeutics at Dyne, leading cross-functional teams to ensure alignment with program strategy and goals. Responsibilities include managing complex decisions, budgeting, coaching team members, and maintaining communication with stakeholders while advocating for patients' needs in muscle disease therapeutics.
The Executive Director of Business Capabilities is responsible for developing strategies to enhance business capabilities in support of Dyne Therapeutics' objectives, overseeing project management and execution, collaborating with business stakeholders, and managing vendor relationships to drive organizational growth.
The Director of Statistical Programming leads statistical programming activities for clinical trials, ensuring high-quality deliverables and adherence to timelines. Responsibilities include developing analysis datasets, reviewing statistical analysis plans, performing complex analyses using SAS and R, managing junior programmers, and collaborating with cross-functional teams on regulatory submissions and innovative programming solutions.
The Senior Scientist will develop and validate bioanalytical assays for novel therapeutics, utilizing ligand binding techniques in various biological matrices. Responsibilities include assay optimization, performance evaluation, data interpretation, and cross-functional collaboration while ensuring compliance with bioanalytical guidance.
The Associate Director, Biostatistics will lead and guide clinical studies, ensuring statistical quality in the design and analysis of clinical trials. Responsibilities include interaction with multidisciplinary teams, development of statistical sections for protocols, contributing to analysis plans, and addressing regulatory queries, particularly in the context of rare diseases.
The Senior Director of Quality Management System is responsible for developing and implementing a fit-for-purpose QMS framework based on GXP standards, managing audits, leading quality teams, and ensuring compliance with industry regulations. The role requires strategic influence across the organization and oversight of quality policies and training programs.
The Senior Accountant supports the finance team with monthly closings, reconciliations, and journal entries while analyzing variances and ensuring compliance with internal controls. This role involves cross-department collaboration, support during audits, and the implementation of accounting policies and systems.