New · posted Nov 6
Dyne Therapeutics · Biotechnology
Associate Director, Clinical Operations Study Lead
- Waltham, MA
- On-site
- Full-time
- Director
The role
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.
What you need
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
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.
What you'll do
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.
Pay
$165,000 – $200,000 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 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% below the US median for Clinical Operations roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US41 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $165,000 | — | $200,000 |
| Massachusetts (middle half) | $194,125 | $200,000 | $221,125 |
| All US (middle half) | $202,000 | $235,000 | $244,000 |
This role: Dyne Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 105 open Clinical Operations 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 38 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct17
- Collaboration and leadership8
- GMP and compliance6
- Documentation and SOPs6
- Investigations and CAPA3
- Quality systems and risk2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in biotechnology, led by the one 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 trials
- 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 E3(official source, opens in a new tab)Structure and content of clinical study reports
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- 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
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- 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
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
Company hiring pulse
Dyne Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 1
- Locations
By discipline
- Quality2 50%
- Clinical2 50%
By level
- Director4 100%
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Associate Director, Clinical Operations Study Lead at Dyne Therapeutics
Open until filled. $165K–$200K a year, employer provided.