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Associate Director, Clinical Operations Study Lead
3 months ago
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The Clinical 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 and 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 without the possibility of being a remote role. Applicants must be able to relocate to the area.
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 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 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 teamsEducation and Skills Requirements:
Minimum of an undergraduate degree in life science or related discipline is required. Advanced scientific or business degree or equivalent experience desirable Minimum of 6-8 years of experience in clinical trial management in conducting Phase I-III global clinical trials, preferably in a clinical-stage biotechnology company managing outsourced clinical trials within quality, timeline and budget expectations Prior site and/or monitoring experience is advantageous Experience running a Phase 3 registrational trial end to end is highly preferred 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#LI-Onsite
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.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
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.
