---
title: 'Director, Drug Safety & Pharmacovigilance Scientist at Dyne Therapeutics'
canonical: 'https://feeny.ai/job/director-drug-safety-pharmacovigilance-scientist-dyne-therapeutics-waltham-6e6cxz3bs5mx'
type: 'job'
last_seen: '2026-09-07'
---

# Director, Drug Safety & Pharmacovigilance Scientist at Dyne Therapeutics

- **Company:** Dyne Therapeutics
- **Location:** Waltham, MA
- **Compensation:** $220k–$240k
- **Posted:** 2026-08-20
- **Last confirmed live:** 2026-09-07
- **Apply:** https://job-boards.greenhouse.io/dynetherapeutics/jobs/6146957004

## 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 Director, Drug Safety & Pharmacovigilance Scientist provides strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management activities across Dyne’s development programs. This role characterizes and communicates the safety profiles of investigational therapies, contributes to regulatory safety strategies and submissions, and ensures pharmacovigilance activities are conducted in compliance with applicable global regulations and company procedures. The Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making. The role applies expert scientific judgment to complex safety data, drives continuous improvement of pharmacovigilance processes, and contributes to a culture focused on patient safety, scientific excellence, and operational rigor.

This position is based in Waltham, MA.

Primary Responsibilities Include:

Safety Surveillance, Signal Detection & Risk Management

- Conduct and lead safety surveillance activities for assigned clinical development programs, including ongoing review of aggregate safety data and identification of emerging safety trends.
- Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management activities across the product lifecycle.
- Review, analyze, and interpret safety information from clinical studies, individual case safety reports (ICSRs), nonclinical studies, scientific literature, and other relevant sources.
- Support medical and scientific review of ICSRs, including evaluation of case narratives, MedDRA coding, causality assessments, expectedness determinations, company comments, and follow-up activities.
- Develop safety monitoring strategies and risk mitigation plans that support effective benefit-risk evaluation.

Safety Reporting, Documentation & Regulatory Support

- Author and contribute to safety signal assessment reports, aggregate safety reports, and safety analyses, including DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.
- Contribute to safety-related sections of clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, reference safety information, clinical study reports, integrated safety summaries, briefing documents, and regulatory submissions.
- Prepare and present safety data, analyses, recommendations, and risk management strategies to cross-functional teams and governance committees.
- Maintain complete, accurate, and inspection-ready documentation of safety surveillance activities, safety decisions, and associated deliverables.

Cross-Functional Leadership & Safety Governance

- Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external vendors to integrate safety considerations into study conduct and program strategy.
- Participate in safety governance forums and cross-functional program teams, providing scientific insight and recommendations to support decision-making.
- Influence safety-related discussions across development programs through clear communication of complex safety data and benefit-risk considerations.
- Foster a culture of collaboration, accountability, scientific excellence, and continuous improvement across Drug Safety & Pharmacovigilance and the broader organization.

Pharmacovigilance Operations, Compliance & Continuous Improvement

- Develop, maintain, and enhance pharmacovigilance SOPs, work instructions, templates, and processes in alignment with global regulatory requirements and industry best practices.
- Provide pharmacovigilance training and guidance to internal colleagues and cross-functional partners on safety surveillance, reporting requirements, documentation practices, and inspection readiness.
- Support pharmacovigilance vendor oversight activities, including review of deliverables, quality assessments, issue escalation, and process improvements.
- Monitor evolving pharmacovigilance regulations, guidance, and industry standards and implement appropriate process enhancements to ensure continued compliance and operational effectiveness

Education and Skills Requirements:

- Advanced degree in life sciences, health sciences, pharmacy, medicine, nursing, or a related discipline required; MD, PharmD, PhD, or equivalent advanced degree preferred.
- 10+ years of relevant pharmacovigilance, drug safety, clinical development, or related biotechnology or pharmaceutical industry experience.
- Demonstrated expertise in safety surveillance, signal detection, signal evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage development programs.
- Experience authoring or contributing to DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and safety-related sections of clinical or regulatory documents.
- Deep knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GVP, GCP, and applicable safety reporting requirements.
- Experience reviewing, analyzing, and interpreting clinical and safety data, including ICSRs, aggregate datasets, safety listings, tables, figures, and data visualizations.
- Working knowledge of safety databases, MedDRA coding, ICSR workflows, safety management plans, and pharmacovigilance vendor oversight practices.
- Demonstrated ability to apply sound scientific and medical judgment to complex safety information and communicate implications effectively to diverse stakeholders.
- Strong analytical, problem-solving, technical writing, presentation, and project management skills.
- Ability to manage multiple priorities and deliver high-quality work in a dynamic, fast-paced environment.
- Proven success collaborating within matrixed organizations and influencing stakeholders without direct authority.
- Strong attention to detail, accountability, integrity, and commitment to patient safety.
- Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology is preferred.

#LI-Onsite

MA Pay Range $220,000—$240,000 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

- [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, 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
- [Senior Director, Business Strategy & Operations - Office of the CCO](https://feeny.ai/job/senior-director-business-strategy-operations-office-of-the-cco-dyne-bwjxcnnqeqed) — Waltham, MA
- [Global Medical Director, Medical Affairs](https://feeny.ai/job/global-medical-director-medical-affairs-dyne-therapeutics-waltham-aan9hnpaxh2q) — Waltham, MA
- [Medical Director, Clinical Development](https://feeny.ai/job/medical-director-clinical-development-dyne-therapeutics-waltham-bjcvm54mvn7y) — Waltham, MA
- [Associate Director, Financial Planning & Analysis (FP&A)](https://feeny.ai/job/associate-director-financial-planning-analysis-fp-a-dyne-therapeutics-waltham-ygd4zj2whn0z) — Waltham, MA