New · posted Nov 11
Dyne Therapeutics · Biotechnology
Director, Clinical Scientist
- Waltham, MA
- On-site
- Full-time
- Director
The role
The Director, Clinical Scientist serves as a scientific and clinical development leader responsible for supporting the strategy, design, execution, interpretation, and communication of Dyne’s clinical studies. This role partners closely with the Clinical Development Lead and cross-functional teams to advance high-quality clinical programs for people living with rare, genetically driven neuromuscular diseases.
This Director-level role requires strong clinical development expertise, scientific judgment, and the ability to translate emerging clinical data into actionable insights that inform study conduct, program strategy, regulatory interactions, and external scientific communications. The Director contributes to clinical development plans, protocol strategy, study execution, data review, regulatory deliverables, investigator engagement, and internal and external data presentations.
The ideal candidate brings a collaborative, patient-focused mindset and can lead complex clinical science workstreams with independence, accountability, and cross-functional influence in a fast-paced, growing biotechnology environment.
This role is based in Waltham, MA.
What you need
Education and Skills Requirements
- Advanced degree in life sciences, healthcare, pharmacy, medicine, nursing, or a clinically relevant discipline required; PhD, PharmD, MD, or equivalent advanced degree preferred.
- 8+ years of relevant experience in clinical development, clinical science, clinical research, or related roles within the pharmaceutical or biotechnology industry.
- Experience supporting or leading interventional clinical trials across multiple phases of development; experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas strongly preferred.
- Experience supporting global, late-stage clinical trials and submissions.
- Demonstrated understanding of clinical development strategy, study design, protocol development, regulatory documentation, data review, clinical trial execution, and study reporting.
- Strong knowledge and experience with GCP, ICH guidelines, FDA, EMA, and other applicable global regulatory requirements for clinical trials.
- Experience developing or contributing to clinical and regulatory documents, including protocols, protocol amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, abstracts, posters, and manuscripts.
- Strong ability to interpret clinical, safety, biomarker, pharmacodynamic, efficacy, and endpoint data and translate findings into clear insights, recommendations, and communications.
- Experience with clinical data review tools and systems, including EDC systems, data listings, patient profiles, dashboards, Excel, PowerPoint, and other tools used to support clinical data review, analysis, and reporting.
- Demonstrated ability to lead complex clinical science workstreams, manage competing priorities, identify risks, resolve issues, and drive deliverables in a fast-paced, matrixed biotechnology environment.
- Strong cross-functional collaboration and influencing skills, with the ability to build alignment across Clinical Development, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Translational Medicine, Medical Affairs, external vendors, and study sites.
- Excellent written, verbal, and presentation skills, with the ability to communicate complex scientific and clinical information clearly to internal and external audiences.
- Strong scientific judgment, critical thinking, attention to detail, and problem-solving skills.
- Ability to operate with independence, sound judgment, accountability, urgency, and flexibility in a growing clinical-stage biotechnology company.
- Experience working with CROs, investigators, study sites, key opinion leaders, advisory boards, or external experts preferred.
- Ability to travel domestically and internationally for trial site visits, investigator meetings, advisory boards, scientific congresses, and internal meetings; approximately 20% travel.
MA Pay Range
$222,000—$258,000 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.
Skills named in this posting
What you'll do
Clinical Development Strategy & Study Leadership
- Serve as a clinical science lead or key clinical science contributor for assigned studies, partnering with the study medical director to support study strategy, design, execution, data interpretation, and reporting.
- Provide scientific input into study design, patient population, eligibility criteria, endpoints, biomarkers, assessments, visit schedules, and data collection strategies to ensure trials are scientifically sound, operationally feasible, and aligned with program objectives.
- Interpret emerging clinical data and translate findings into clear recommendations for study conduct, clinical development strategy, internal governance discussions, regulatory interactions, and external scientific communications.
- Maintain current knowledge of rare disease, neuromuscular disease, genetic medicine, oligonucleotide therapeutics, clinical trial innovation, regulatory expectations, competitive developments, and relevant scientific literature.
Clinical Trial Execution & Cross-Functional Collaboration
- Partner closely with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Translational Medicine, Medical Affairs, Quality, CROs, vendors, and other stakeholders to support high-quality study execution.
- Monitor study progress, identify scientific, clinical, operational, or data-related risks, and partner with cross-functional teams to define practical mitigation strategies that support quality, timelines, and patient safety.
- Collaborate with Clinical Operations on oversight of study milestones and overall study metrics.
- Represent Clinical Development on cross-functional study teams, workstreams, and governance discussions, as assigned providing clear scientific input and influencing alignment without direct authority.
- Collaborate with investigators, key opinion leaders, external experts, CROs, and vendors to support scientific exchange, study execution, issue resolution, and alignment with clinical development objectives.
- Support Study Medical Monitor in overseeing CRO Medical Monitoring team, including review of meeting minutes, meeting materials, and support for medical monitoring deliverables.
Clinical Data Review, Interpretation & Safety Oversight
- Support ongoing patient-level and aggregate clinical data review, including safety, efficacy, biomarker, pharmacodynamic, endpoint, and protocol compliance data, to identify trends, insights, risks, protocol deviations, safety trend review, patient profile review and other potential issues.
- Partner with Pharmacovigilance and Clinical Development colleagues to support safety surveillance, signal evaluation, benefit-risk assessment, safety narratives, and timely escalation of clinically meaningful findings.
Clinical and Regulatory Deliverables
- Lead or contribute to the development of clinical study concepts, protocol synopses, protocols, protocol amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, and other key clinical and regulatory deliverables.
- Contribute to regulatory submissions and interactions by preparing, reviewing, and interpreting clinical content for INDs, CTAs, briefing books, annual reports, DSURs, submission dossiers, and responses to regulatory questions.
- Support investigator meetings, site engagement, advisory boards, data monitoring committee materials, steering committee materials, and other internal or external scientific forums as needed.
- Contribute to internal and external presentations, abstracts, posters, manuscripts, publications, and other scientific communications that summarize clinical data clearly and accurately.
Pay
$222,000 – $258,000 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.
Leadership, Mentorship & Dyne Culture
- Mentor, coach, or provide guidance to clinical scientists, study team members, or cross-functional colleagues as appropriate, helping strengthen clinical science capabilities and quality of execution.
- Model Dyne’s core values and demonstrate accountability, collaboration, urgency, integrity, scientific excellence, and commitment to patients in all internal and external interactions.
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 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Massachusetts66 roles publishing pay
Director roles in the US224 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $222,000 | — | $258,000 |
| Massachusetts (middle half) | $253,500 | $298,500 | $322,625 |
| All US (middle half) | $255,000 | $300,000 | $335,500 |
This role: Dyne Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 296 open Clinical Development 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 40 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct22
- Collaboration and leadership19
- Investigations and CAPA8
- Documentation and SOPs7
- Data and digital systems3
- GMP and compliance2
- Regulatory submissions2
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
Company hiring pulse
Dyne Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Clinical3 60%
- Quality2 40%
By level
- Director5 100%
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Director, Clinical Scientist at Dyne Therapeutics
Open until filled. $222K–$258K a year, employer provided.