Dyne Therapeutics
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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
Role Summary: The Clinical Trial Manager 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 and SOPs. This individual may be responsible for one medium complexity or multiple lower complexity clinical studies. This role may also support management of certain aspects of one or more high complexity studies led by a Clinical Study Lead. This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities:
Manage, either independently or in partnership with COSL, all operational aspects from start‑up to close‑out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance with applicable SOPs, guidelines and regulations
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
Monitor and assess vendor performance against contractual operational deliverables
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
Participate in cross‑functional teams and manage study team in partnership with the CRO
Participate in a site engagement program to build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
Participate in 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 ensure the TMF and study is always "inspection ready"
Prepare high‑quality reports and dashboards (financial, project, etc.) for senior management on program status and issues as required
Education and Skills Requirements:
Minimum of a B.A. or B.S. degree in life science or related discipline is required; advanced degree desirable
Minimum of 3‑5 years of clinical trial management experience in conducting Phase I‑III international clinical trials in pharma/biotech organization
Scientifically and clinically astute with very strong project management skills
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
Experience with clinical studies in muscular dystrophies desirable
Demonstrated ability to lead teams in a fast‑paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
Understand technical, scientific and medical information, to plan, organize, project manage and analyze data
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
Excellent interpersonal and decision‑making skills
Demonstrated innovation, possesses drive, energy and enthusiasm to deliver the program objectives
Excellent planning, time management & coordination skills
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Experience in working in a small organization
Ability to travel for up to 20% is required (including overnight stays and international travel)
Excellent written and oral communication skills
Full competency in Microsoft Office programs
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.
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Role Summary: The Clinical Trial Manager 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 and SOPs. This individual may be responsible for one medium complexity or multiple lower complexity clinical studies. This role may also support management of certain aspects of one or more high complexity studies led by a Clinical Study Lead. This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities:
Manage, either independently or in partnership with COSL, all operational aspects from start‑up to close‑out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance with applicable SOPs, guidelines and regulations
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
Monitor and assess vendor performance against contractual operational deliverables
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
Participate in cross‑functional teams and manage study team in partnership with the CRO
Participate in a site engagement program to build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
Participate in 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 ensure the TMF and study is always "inspection ready"
Prepare high‑quality reports and dashboards (financial, project, etc.) for senior management on program status and issues as required
Education and Skills Requirements:
Minimum of a B.A. or B.S. degree in life science or related discipline is required; advanced degree desirable
Minimum of 3‑5 years of clinical trial management experience in conducting Phase I‑III international clinical trials in pharma/biotech organization
Scientifically and clinically astute with very strong project management skills
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
Experience with clinical studies in muscular dystrophies desirable
Demonstrated ability to lead teams in a fast‑paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
Understand technical, scientific and medical information, to plan, organize, project manage and analyze data
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
Excellent interpersonal and decision‑making skills
Demonstrated innovation, possesses drive, energy and enthusiasm to deliver the program objectives
Excellent planning, time management & coordination skills
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Experience in working in a small organization
Ability to travel for up to 20% is required (including overnight stays and international travel)
Excellent written and oral communication skills
Full competency in Microsoft Office programs
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.
#J-18808-Ljbffr