Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. Role Summary: The Clinical Operations Study Lead ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs).

This position is responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements.

This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne’s policies ad SOPs.   This individual may be responsible for one highly complex or multiple medium complexity clinical studies. This role is expected to require up to 20% travel, including international travel.    This role is based in Waltham, MA.  Primary Responsibilities Include:  Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations  Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP  Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities  Support the selection, oversight, and management of CROs and other vendors  Monitor and assess vendor performance against contractual operational deliverables.  Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors  Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track  Lead cross-functional teams and manage study team in partnership with the CRO  Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities  Responsible for planning and conducting investigator meetings together with the CRO  Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time  Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data  Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required  Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances  Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate  Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready”  Prepare high-quality reports (financial, project, etc.) for senior management on program status and issues as required  Provide management, oversight, coaching, mentoring, and development to team of indirect reports supporting the clinical trials team and cross-functional teams    Education and Skills Requirements:  Undergraduate degree in a scientific or health related discipline.

Advanced scientific or business degree or equivalent experience desirable  8+ years of clinical trial management experience in conducting Phase I-III global clinical trials, preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline and budget expectations.  Prior site and/or monitoring experience is advantageous  Experience across several complex therapeutic areas; neuromuscular or muscle disease experience preferred.  Experience with rare disease and/or pediatric trials also preferred  Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws  Understand clinical study budgets, accruals and forecasting  Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously  Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships  Experience in vendor selection and overseeing studies being managed by a CRO  Ability to successfully engage and work collaboratively with clinical operations team members/colleagues and other functions, including Medical Affairs and Commercial, as necessary  Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs  Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality)  Excellent communication skills   #LI-OnsiteMA Pay Range$159,000—$195,000 USD  The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting.

Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.