---
title: 'Associate Director, Clinical Operations Study Lead at Dyne Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-clinical-operations-study-lead-dyne-therapeutics-waltham-evbyf6dxekgd'
type: 'job'
last_seen: '2026-09-14'
---

# Associate Director, Clinical Operations Study Lead at Dyne Therapeutics

- **Company:** Dyne Therapeutics
- **Location:** Waltham, MA
- **Compensation:** $165k–$200k
- **Posted:** 2026-09-11
- **Last confirmed live:** 2026-09-14
- **Apply:** https://job-boards.greenhouse.io/dynetherapeutics/jobs/6188445004

## Job description

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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0), and follow us on [X](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0), [LinkedIn](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0) and [Facebook](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0).

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
- Perform and document sponsor oversight activities for outsourced trial activities, including oversight of CRO performance, KPIs, KRIs, protocol deviations, quality events, risks, and CAPAs to ensure compliance with regulatory expectations and company standards.
- 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
- Contribute to clinical operations functional initiatives, including process improvement, inspection readiness, department standards, lessons learned, and implementation of operational best practices.

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-Onsite MA Pay Range $165,000—$200,000 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.

## About Dyne Therapeutics

## Company Overview
- **One-liner**: Dyne Therapeutics is a clinical-stage biotechnology company developing targeted nucleic acid therapies for genetically driven neuromuscular diseases using its proprietary FORCE™ platform.
- **Entity Type**: Public (NASDAQ: DYN)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: 2018
- **Founders**: Not publicly available (the company was co-founded by a team of scientists and entrepreneurs; individual names not surfaced in search results)

## Core Business
- **Primary industry**: Biotechnology / Biopharmaceuticals – rare neuromuscular disease therapeutics
- **Target customers**: B2B / B2G – regulatory agencies, healthcare providers, payers, and most importantly patients with Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), facioscapulohumeral muscular dystrophy (FSHD), and Pompe disease.
- **Mission / Purpose**: “Delivering functional improvement for people living with neuromuscular diseases.” [dyne-tx.com](https://www.dyne-tx.com/)

## Products & Services
Dyne’s pipeline is built around its FORCE™ platform, which uses an antigen-binding fragment (Fab) conjugated to transferrin receptor 1 (TfR1) to deliver therapeutic payloads to muscle and the central nervous system.

- **Z‑rostudirsen (DYNE‑251)** – An investigational therapeutic for DMD patients amenable to exon 51 skipping. Consists of a phosphorodiamidate morpholino oligomer (PMO) conjugated to an anti‑TfR1 Fab. Phase 1/2 DELIVER trial met primary endpoint; BLA submission for U.S. Accelerated Approval planned for Q2 2026 with potential launch in Q1 2027. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
- **Z‑basivarsen (DYNE‑101)** – Investigational therapeutic for DM1, using an antisense oligonucleotide (ASO) conjugated to anti‑TfR1 Fab. Phase 1/2 ACHIEVE trial fully enrolled; Phase 3 HARMONIA trial ongoing. [dyne-tx.com](https://www.dyne-tx.com/pipeline/)
- **DYNE‑302** – Preclinical candidate for FSHD, using an siRNA payload to suppress DUX4 expression. [dyne-tx.com](https://www.dyne-tx.com/pipeline/)
- **DMD Franchise Expansion** – Four additional development candidates (DYNE‑253, DYNE‑245, DYNE‑244, DYNE‑255) targeting exons 53, 45, 44, and 55 for DMD, entering IND‑enabling studies. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)

## Market Standing
- **Valuation / Market Cap**: Not disclosed in search results (public company; market cap fluctuates with stock price; current figure not provided in the sources).
- **Key Metric**: Cash, cash equivalents and marketable securities of **$1.1 billion** as of December 31, 2025, providing runway into Q1 2028. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
- **Notable Investors / Partners**: Not listed in provided search results (likely institutional investors; prior venture rounds not detailed here).
- **Growth Signals**:
  - Headcount grew **38.2% YoY** to **227 employees** (2025). [linkedin.com](https://www.linkedin.com/company/dynetx)
  - Positive topline results from DELIVER trial for z‑rostudirsen; potential first product launch in Q1 2027 if approved.
  - Advancing five distinct clinical/preclinical programs across multiple neuromuscular indications.

## Competitive Advantages
- **FORCE™ Platform**: Differentiated delivery technology that uses a TfR1‑binding Fab to enable broad and deep tissue penetration in both muscle and CNS – addressing one of the biggest hurdles in neuromuscular drug development.
- **Best‑in‑Class Potential**: Clinical data for z‑rostudirsen showed statistically significant dystrophin expression (5.46% of normal at 6 months, 7‑fold change) and preservation of lung function (FVC%p) compared to placebo, despite a small trial not powered for functional endpoints.
- **Broad Pipeline**: Covering multiple exon‑skipping opportunities in DMD as well as entirely different diseases (DM1, FSHD, Pompe) with the same core platform, reducing risk and enabling rapid expansion.

## Strategic Focus
- **Regulatory Submission**: File a Biologics License Application (BLA) for z‑rostudirsen in Q2 2026 under U.S. Accelerated Approval pathway.
- **Late‑Stage Trials**: Initiate two field‑defining Phase 3 confirmatory trials (FORZETTO for DMD and HARMONIA for DM1) in 2026 following FDA alignment on design.
- **Pipeline Expansion**: Move four additional DMD exon‑skipping candidates into IND‑enabling studies and advance preclinical DYNE‑302 (FSHD) toward the clinic.
- **Commercial Readiness**: Prepare for potential first‑ever company launch in Q1 2027 with a focus on U.S. market, while also pursuing ex‑U.S. approval pathways.

## Why Work Here
- **Mission‑Driven Culture**: The company’s “One Dyne community” ethos emphasizes accountability, transparency, fearlessness, and a relentless drive to deliver functional improvement for patients and families. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/)
- **Competitive Benefits**: Medical, dental, vision, 401(k), flexible vacation, paid holidays including a year‑end office closure, short‑ & long‑term disability, HSA/FSA accounts. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/)
- **Work Environment**: Office location in Waltham, MA (Boston area). Remote/hybrid policy not specified in search results; likely on‑site or hybrid for lab‑based roles. Career page lists roles such as Associate Director, Oligonucleotide Development; Scientist, RNA; Director of Training – reflecting a mix of research, clinical, and corporate functions. [job-boards.greenhouse.io](https://job-boards.greenhouse.io/dynetherapeutics)
- **Growth Opportunity**: Joining a late‑stage biotech with a validated platform, strong cash position, and a clear path to commercialization – offering employees exposure to both R&D and upcoming launch activities.
- **Recruitment Scam Warning**: Dyne posts an explicit notice on its careers page that it never requests financial details or payment during hiring; all legitimate emails come from @dyne‑tx.com addresses.

## Sources
1. [dyne-tx.com – Company Overview](https://www.dyne-tx.com/)
2. [dyne-tx.com – Careers & Culture](https://www.dyne-tx.com/careers-culture/)
3. [dyne-tx.com – Pipeline](https://www.dyne-tx.com/pipeline/)
4. [investors.dyne-tx.com – Q4/Full Year 2025 Results](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
5. [linkedin.com – Dyne Therapeutics Company Profile](https://www.linkedin.com/company/dynetx)
6. [job-boards.greenhouse.io – Dyne Careers Page](https://job-boards.greenhouse.io/dynetherapeutics)

## Other roles at Dyne Therapeutics

- [Associate Director, HCP Marketing - DMD](https://feeny.ai/job/associate-director-hcp-marketing-dmd-dyne-therapeutics-remote-r1dnck9gh1bz)
- [Executive Director, TechOps Alliance and Strategic Partnerships](https://feeny.ai/job/executive-director-techops-alliance-and-strategic-partnerships-dyne-wxv9qjfras07) — Waltham, MA
- [Senior Director, Quality Control](https://feeny.ai/job/senior-director-quality-control-dyne-therapeutics-waltham-0c14xebc380b) — Waltham, MA
- [Senior Director, Medical Affairs Learning & Development](https://feeny.ai/job/senior-director-medical-affairs-learning-development-dyne-therapeutics-waltham-mvej99ejr8y0) — Waltham, MA
- [Director, Clinical Scientist](https://feeny.ai/job/director-clinical-scientist-dyne-therapeutics-waltham-jw10cdn5v3ms) — Waltham, MA
- [Scientist, Bioconjugation](https://feeny.ai/job/scientist-bioconjugation-dyne-therapeutics-waltham-jg9q1pw4whag) — Waltham, MA
- [Principal Scientist,  Oligonucleotide (PMO, ASO) Development](https://feeny.ai/job/principal-scientist-oligonucleotide-pmo-aso-development-dyne-therapeutics-2x39whh9swds) — Waltham, MA
- [Director, Drug Safety & Pharmacovigilance Scientist](https://feeny.ai/job/director-drug-safety-pharmacovigilance-scientist-dyne-therapeutics-waltham-6e6cxz3bs5mx) — Waltham, MA
- [Director, People Operations](https://feeny.ai/job/director-people-operations-dyne-therapeutics-waltham-x79gkrh2bafa) — Waltham, MA
- [Associate Director, Talent Acquisition Operations & Programs](https://feeny.ai/job/associate-director-talent-acquisition-operations-programs-dyne-therapeutics-t369xmxga1xg) — Waltham, MA