New · posted Oct 31
Dyne Therapeutics · Biotechnology
Director, Drug Safety & Pharmacovigilance Scientist
- Waltham, MA
- On-site
- Full-time
- Director
The role
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.
What you need
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.
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.
What you'll do
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
Pay
$220,000 – $240,000 a year
Employer providedWhere you'll work
Waltham, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Waltham, MA
From the posting
About Dyne Therapeutics
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/, and follow us on X, LinkedIn and Facebook.
Equal opportunity, accessibility and legal noticesDyne Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Director roles in Massachusetts26 roles publishing pay
Director roles in the US87 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $220,000 | — | $240,000 |
| Massachusetts (middle half) | $212,500 | $229,000 | $291,000 |
| All US (middle half) | $221,250 | $263,500 | $279,250 |
This role: Dyne Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 161 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Dyne Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Documentation and SOPs9
- Clinical trial conduct9
- Quality systems and risk6
- GMP and compliance5
- Regulatory submissions3
- Investigations and CAPA2
- Data and digital systems2
- Lab testing and methods1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Dyne Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Quality2 40%
- Clinical2 40%
- Regulatory1 20%
By level
- Director5 100%
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Director, Drug Safety & Pharmacovigilance Scientist at Dyne Therapeutics
Open until filled. $220K–$240K a year, employer provided.