---
title: 'Medical Director, Clinical Development at Dyne Therapeutics'
canonical: 'https://feeny.ai/job/medical-director-clinical-development-dyne-therapeutics-waltham-bjcvm54mvn7y'
type: 'job'
last_seen: '2026-09-07'
---

# Medical Director, Clinical Development at Dyne Therapeutics

- **Company:** Dyne Therapeutics
- **Location:** Waltham, MA
- **Compensation:** $270k–$310k
- **Posted:** 2026-07-31
- **Last confirmed live:** 2026-09-07
- **Apply:** https://job-boards.greenhouse.io/dynetherapeutics/jobs/6131091004

## 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 Medical Director, Clinical Development serves as a key member of the DM1 clinical development team and has primary responsibility for the execution of critical study(s) in the DM1 clinical program, which will include supporting the integrated development strategy. This role is responsible for ensuring participant safety, supporting high-quality study execution, interpreting emerging clinical and safety data, and providing timely medical input to study teams, investigators, vendors, and cross-functional partners. This role serves as the medical monitor on their assigned study(s), partnering closely with Clinical Development leadership, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics, Data Management, Translational Medicine, and other key stakeholders to support study design, protocol execution, medical review, data analysis, and regulatory deliverables. This individual will serve as the medical monitor for assigned studies, provide medical guidance on study conduct and risk mitigation, support responses to regulatory agency queries, and help ensure that clinical trials are conducted in accordance with GCP, ICH guidelines, applicable regulations, Dyne SOPs, and the highest standards of patient safety and scientific integrity.

This role is based in Waltham, MA.

Primary Responsibilities Include:

Clinical Development Strategy and Study Design

- Contribute to the planning, design, development, and implementation of clinical trials for assigned drug candidates
- Apply knowledge of disease mechanisms to support selection and interpretation of biomarkers, pharmacodynamic and clinical endpoints, and patient stratification considerations
- Contribute to the development and implementation of effective, timely studies to establish the safety, tolerability, pharmacodynamic activity, and efficacy of assigned drug candidates
- Contribute to integrated product and clinical development plans, ensuring medical monitoring activities align with broader program objectives
- Provide medical input to Research, Translational Medicine, Biomarkers, and other cross-functional partners on decisions with clinical components and implications

Medical Monitoring, Safety, and Participant Oversight

- Serve as medical monitor for assigned studies, providing timely medical guidance to study teams, investigators, CROs, vendors, and advisors
- Review clinical and safety data, eligibility questions, protocol deviations, adverse events, serious adverse events, and other medically relevant information to support participant safety and study integrity
- Partner with Pharmacovigilance and Clinical Development leadership to support safety surveillance, signal detection, benefit-risk assessment, and timely escalation of emerging safety concerns
- Support study-level risk assessments, medical monitoring plans, data review plans, dose review discussions, and safety review meetings

Clinical Study Execution and Vendor Oversight

- Collaborate with Clinical Operations to ensure assigned study activities are completed in accordance with applicable regulations, GCP, ICH guidelines, Dyne SOPs, and study timelines
- Ensure compliance with applicable regulatory standards related to global clinical trials and interactions with physicians
- Support the development, implementation, and maintenance of SOPs for clinical trials and related activities, as required
- Support site engagement, investigator training, enrollment strategy, medical issue resolution, and inspection readiness for assigned studies
- Partner with Clinical Operations on outsourcing and in-house approaches for clinical development capabilities and implementation plans
- Manage relationships with CROs, vendors, and external collaborative partners supporting clinical development efforts

Data Review, Regulatory Support, and Scientific Deliverables

- Review and interpret emerging clinical, safety, biomarker, pharmacodynamic, and endpoint data to inform study conduct, program strategy, and regulatory interactions
- Contribute medical review and interpretation for protocols, investigator brochures, informed consent forms, clinical study reports, briefing materials, safety narratives, and regulatory responses
- Support regulatory submissions and interactions with health authorities by providing study-specific medical input and data interpretation
- Represent the company in interactions with regulatory agencies, as required
- Manage the writing, review, and accountability for key clinical and regulatory documents, including protocols, investigator brochures, informed consent forms, regulatory submissions, abstracts, peer-reviewed articles, presentations, and publications
- Support abstracts, presentations, publications, and other scientific communications, as appropriate

External Engagement and Relationship Management

- Identify, manage, and interface with external collaborators, investigators, advisors, and key opinion leaders to support clinical development strategies for a novel class of therapeutics
- Develop and maintain professional relationships with academic and community-based study sites
- Participate, as requested, in Business Development due diligence, advisory boards, investigator meetings, and presentations to external constituencies

Cross-Functional Leadership and Communication

- Maintain accountability for relevant timelines and deliverables in close partnership with functional counterparts and clinical development colleagues
- Coordinate and communicate with internal departments and external vendors to ensure study objectives, timelines, and deliverables are accomplished
- Manage, coordinate, and provide ongoing assessment, evaluation, and communication with internal departments and external vendors to support successful study execution
- Provide timely updates to Clinical Development leadership and cross-functional partners on study progress, medical issues, emerging risks, changes in scope, schedule, and resources
- Interface with functions within and outside of R&D, including Finance, Regulatory Affairs, Legal, Commercial, and Medical Affairs
- Provide leadership and mentorship to clinical development team members, including matrixed team members and potential direct reports

Education and Skills Requirements:

- Doctor of Medicine degree; board certification or advanced training in neurology, neuroscience, neuromuscular disease, pediatrics, internal medicine, or a related specialty preferred, or other relevant degree
- 5+ years of relevant experience, with 3+ years of clinical development, medical monitoring, pharmacovigilance, clinical research, or related roles within the pharmaceutical or biotechnology industry
- Experience serving as a medical monitor or providing medical oversight for interventional clinical trials
- Experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas preferred
- Strong understanding of clinical trial design, protocol execution, medical data review, safety monitoring, and clinical development processes
- Working knowledge of FDA, EMA, ICH, GCP, and other applicable regulatory requirements for clinical trials
- Regulatory experience with Pre-lNDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US
- Experience reviewing and contributing to clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, clinical study reports, safety narratives, briefing materials, and regulatory responses
- Ability to interpret clinical, safety, biomarker, pharmacodynamic, and efficacy data and translate findings into clear medical recommendations
- Strong clinical judgment and ability to assess participant safety, protocol eligibility, adverse events, and medically complex study questions
- Demonstrated ability to work effectively in a fast-paced, matrixed biotechnology environment with cross-functional partners and external vendors
- Strong collaboration skills with the ability to influence without authority, build alignment, and drive practical solutions across teams
- Excellent written, verbal, and presentation skills, with the ability to communicate complex medical and scientific information clearly to internal and external audiences
- Strong attention to detail, organizational skills, and ability to manage multiple priorities while maintaining high-quality execution
- Ability to operate with appropriate independence, sound judgment, urgency, and accountability
- Experience working with CROs, investigators, study sites, and external experts preferred
- Willingness to be hands-on and contribute across strategic and executional activities in a growing clinical-stage biotechnology company
- Ability to travel as needed for investigator meetings, site engagement, advisory boards, congresses, and internal meetings

#LI-Onsite MA Pay Range $270,000—$310,000 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)

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- [Director, Drug Safety & Pharmacovigilance Scientist](https://feeny.ai/job/director-drug-safety-pharmacovigilance-scientist-dyne-therapeutics-waltham-6e6cxz3bs5mx) — Waltham, MA
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