Associate Director, Clinical Site Liaison

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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and 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 https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.  Role Summary: The Clinical Site Liaison is responsible for developing and nurturing strong Dyne Therapeutics – Clinical Trial Site relationships while also optimizing site performance, particularly enrollment, and overseeing CRO site management and monitoring activities, using a risk-based approach. The primary goal of this role is to build/support site relationships while also ensuring quality monitoring oversight and delivery of data of high integrity. The individual in this role is responsible for working directly with the internal study teams, CRO partners and clinical trial sites.  Primary Responsibilities Include:  Site Relationship Management  Enhance the development and maintenance of Dyne’s relationships with clinical investigators and site staff   Provide an interface among study sites, Dyne Therapeutics and CRO partners to create an optimal environment for clinical trials, enabling timely and high-quality output  Coordinate regular, fit for purpose, communication with clinical sites to align interactions with CRO and relevant internal stakeholders to assure a harmonized approach to site relationship and optimize site performance and quality delivery  May attend SIVs and Motivational/Booster visits/calls in collaboration with CRO partner   Recruitment Support  Maintain an operational knowledge of the protocol(s), answer site/CRO questions as applicable and assist in the escalation process in connecting site/CRO to Dyne Therapeutics personnel  Leverage experience and deep insight from interactions with clinical sites to provide strategic input on effective recruitment, outreach, and optimization strategies.  Maintain and assist with the development of plans and tools to carry out these strategies, as appropriate  Monitoring Support  In collaboration with CRO partners and as approved by the Clinical Operations Study Lead (COSL), perform on-site visits in support of continued site engagement and data quality, identify and remove barriers to performance and to oversee on-site outsourced monitoring activities  Document and communicate observations from onsite monitoring activities (such as key areas of risks and noncompliance)  Provide ongoing risk assessment review of available data resources, review the site performance/CRO monitoring performance to identify trends, risks, and opportunities.  In collaboration with the COSL, perform review of monitoring visit reports (on-site and central review reports) completed by CRO partner  Contribute to process improvements and knowledge/ sharing of best practices  Education and Skills Requirements:  Bachelor’s Degree or international equivalent required; Life Sciences preferred.

Advanced degree highly desirable  Strong knowledge of ICH/GCP  At least 8 years of relevant clinical trial research experience  Onsite/central monitoring and/or clinical lead/study-management experience  Clinical site facing experience required  Monitoring experience in rare disease preferred  Biotech or pharma industry experience is required  Experience overseeing/managing outsourced site management and monitoring activities  Excellent verbal and written communication skills  Excellent attention to details  Ability to travel, 30% or more frequently at times   MA Pay Range$155,000—$190,000 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.

Dyne Therapeutics is a biotechnology company dedicated to advancing life-changing therapies for patients with serious muscle diseases. Leveraging its expertise in muscle biology, nucleic acid delivery, and gene therapy, Dyne is at the forefront of developing innovative treatments to address unmet medical needs and improve the lives of individuals affected by muscle disorders.