Associate Director, Clinical Operations Study Lead

Role Summary:

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.

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.

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

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