Senior Clinical Trial Manager

Senior Clinical Trial Manager

Hybrid

Stoke Therapeutics is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary TANGO approach, Stoke is developing antisense oligonucleotides to selectively restore naturally-occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke's initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke's proprietary approach. Stoke is headquartered in Bedford, Massachusetts.

The Sr. Clinical Trial Manager must have experience as a Global Study Lead in an outsourced model (i.e. providing oversight to CROs and vendors), as well as managing vendors, with a focus on study start up and study execution to ensure vendor/system/and cross functional integration throughout the study. The Sr. CTM is responsible for the successful execution of a clinical trial from protocol concept through clinical study report, ensuring completion of all study deliverables, including proactive risk/issue identification and mitigations. Ideally, the candidate has rare disease and pediatric experience (preferable, not required), as well as dose escalating/dose finding study experience that includes Safety Monitoring Committee (SMC).

Key Responsibilities:

• Leading a cross-functional clinical study team and responsible for leading and managing all aspects of assigned clinical study(ies) with oversight to the partner CROs and vendors, by ensuring assigned studies are conducted according to the protocol, GCP and within timelines and budget per the Clinical Development Plan (CDP).
• Oversees and lead role in the identification process of conducting study feasibility, selecting sites/countries and ensuring that sites are activated in a timely manner
• Responsible for overseeing selection/qualification of vendors, set up of these vendors is done correctly. Ensures where necessary that UATs are completed effectively where needed
• Provides input into clinical study protocols, informed consent forms (ICFs) and other clinical study documents.
• Responsible for overseeing development of study operational plans to ensure study compliance and quality is maintained.
• Oversees the development of and adherence to clinical study timelines as per the Clinical Development Plan (CDP) and collaborates with internal functional stakeholders for alignment.
• Proactively identify study risks and coordinate risk identification and mitigations with the study team, CRO and vendors and escalate risks as needed.
• Provides effective vendor and CRO oversight and ensures that the study is being completed in compliance to the protocol and GCP
• Coordinates the relevant and timely exchange of study status with internal functional stakeholders to support clinical study delivery per the CDP.
• Coordinates with CMC regarding drug forecasting and supply of drug products to sites.
• Supports timely and efficient databases lock (including interim locks) by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts.
• Adheres to clinical study budgeting process and provides input to finance on budget accruals and forecasts.
• Participates in clinical study scenario planning by estimating timelines and cost. Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance.
• Demonstrates a high level of knowledge of clinical operations' methodologies, organizational, project management and study team leadership capabilities.
• Ensure Trial Master File (TMF) meets inspection readiness requirements.
• Provides and reviews study dashboards with cross functional team.
• Actively participates in the development of department initiatives, including the development /definition of SOPs and processes.

Required Skills & Experience:

• Bachelor's degree or higher in a scientific or healthcare discipline preferred.
• Minimum of 8 (Sr. CTM) years of progressive experience leading global pivotal clinical trials within biotech, pharmaceutical, CRO industry or equivalent clinical research experience.
• Experience in managing and providing oversight to CRO and vendors and ensuring they are delivering on time, with quality and within budget
• Experience in providing oversight review of PSVs, SIVs, IMVs, and COVs required.
• Pediatric rare disease and Neurology clinical study experience are highly desirable.
• Strong knowledge of ICH-GCP guidelines and regulations.
• Strong knowledge of Drug Development process
• Proficiency in Microsoft Word, Excel, and Outlook, PowerPoint, and MS Project
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Location(s): Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is remote, with on site work approximately 1 day a week, and the flexibility to be in the office when needed, currently based in Bedford and will later be based in Waltham.

Travel: This position will require approximately 15% travel.

Culture & Values: At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.