Clinical Trial Manager at Dyno Therapeutics

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Based in Waltham, MA (no remote possibility)
Ensures study conduct adheres to ICH GCP guidelines, local regulatory requirements, and Dyne’s policies and SOPs
Manages one medium complexity or multiple lower complexity clinical studies, or supports certain aspects of one or more high complexity studies led by a Clinical Study Lead

Responsibilities

Manage, independently or in partnership with COSL, all operational aspects from start-up to close-out of studies to assure adherence to timelines, budget, milestones, 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 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

Skills

Key technologies and capabilities for this role

Clinical Trial ManagementCRO OversightVendor ManagementICH GCPRegulatory ComplianceSOP AdherenceStudy Start-upStudy Close-outBudget ManagementTimeline ManagementCross-functional Collaboration

Questions & Answers

Common questions about this position

Is this role remote or office-based?

This role is based in Waltham, MA without the possibility of being a remote role.

What are the main responsibilities of the Clinical Trial Manager?

The role involves managing operational aspects of clinical trials from start-up to close-out, overseeing CROs and vendors, ensuring compliance with regulations, and tracking budgets and timelines.

What skills or experience are needed for this position?

Experience leading clinical trials across phases, managing CROs and vendors, budget tracking, and ensuring compliance with ICH GCP guidelines and regulations is required.

What is the compensation or salary for this role?

This information is not specified in the job description.

What makes a strong candidate for this Clinical Trial Manager role?

Strong candidates will have experience independently managing medium complexity studies or supporting high complexity ones, with skills in cross-functional collaboration, vendor oversight, and site engagement.

Dyno Therapeutics

Develops AI-optimized gene therapy vectors

About Dyno Therapeutics

Dyno Therapeutics focuses on advancing gene therapy by utilizing Artificial Intelligence to create Adeno-associated virus (AAV) vectors. These vectors are essential tools for delivering genetic material into cells, which is crucial for effective gene therapy. The company's AI technology enables the design and optimization of these vectors, potentially enhancing the success of gene therapies. Dyno collaborates with major pharmaceutical and biotech companies, such as Astellas, Roche, Sarepta, and Novartis, to develop therapies for various diseases affecting the skeletal and cardiac muscles, central nervous system, liver, and eyes. Unlike many competitors, Dyno's unique approach leverages AI to improve the performance of AAV vectors, setting it apart in the biotech field. The company's goal is to improve gene therapy outcomes through its advanced vector technology, ultimately benefiting patients with serious health conditions.

Watertown, MassachusettsHeadquarters

2018Year Founded

$106MTotal Funding

SERIES_ACompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Remote Work Options

Risks

Gene therapy investment slowdown may impact Dyno's growth and innovation.

Manufacturing bottlenecks could hinder scaling of Dyno's operations.

Increased competition from companies like Form Bio challenges Dyno's market position.

Differentiation

Dyno uses AI to design optimized AAV vectors for gene therapy.

Their AI-driven CapsidMap platform enhances AAV vector development for muscle gene therapies.

Partnerships with major pharma companies like Astellas and Roche boost Dyno's market presence.

Upsides

AI-driven capsid design improves delivery efficiency and reduces manufacturing costs.

Collaboration with NVIDIA enhances biological sequence design for gene therapies.

Generative AI increases efficiency of eye and brain-targeted capsid delivery significantly.

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