Associate Director, Clinical Scientist

Role Summary:

Reporting to the Clinical Development Lead, the Clinical Scientist, Associate Director is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. The successful candidate will work independently in collaboration with the Clinical Development Lead and other cross-functional team members in the execution of clinical trial protocols, analysis of clinical trial data, review of regulatory documents, and summary of key data for internal and external presentations.

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

Primary Responsibilities Include:

• In collaboration with the Clinical Development Lead, be accountable for the scientific aspects of the design, implementation, and conduct of clinical trials with both internal and external stakeholders (e.g., investigator meeting presentations, data reviews and summaries, protocol deviation reviews, etc.) 
• Contribute to the development and creation of clinical trial protocols and protocol amendments in close collaboration with the clinical development program lead and cross-functional team members.  
• Contribute to the creation and amendment of study-level documents, including drug handling and administration documents, clinical assessment manuals, informed consent forms, and preparation of clinical sections of key regulatory documents, including Investigator’s Brochures, briefing books, and submission dossiers.  
• Contribute to high quality clinical safety and efficacy data review and identify clinical data insights through ongoing patient-level review and trends analysis. 
• Contribute to high quality clinical study execution, including reviewing protocol deviations and trends analysis, addressing site queries, collaborating with Clinical Operations, and liaising with external vendors.
• Assist with review and interpretation of clinical study data and production of both internal and external facing data presentations. 
• Assist and collaborate with cross-functional team members to maintain clinical development plans to be aligned with key strategic goals of the company. 

Education and Skills Requirements:

• Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required such as a PharmD, PhD, or MD
• 8+ years of pharmaceutical industry experience preferred
• 1+ years as a Clinical Trial Scientist or comparable role 
• Strong familiarization with Good Clinical Practice (GCP) and drug development processes 
• Expertise in neuromuscular disease biology and rare disease experience strongly preferred 
• Good knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution
• Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, PowerPoint, Veeva CRM) for data collection, analysis and reporting
• Ability to effectively prioritize tasks and comfortable working highly independently in a cross-collaborative matrix environment 
• Experience working at a small company with tight timelines preferred 
• Lives in proximity to Waltham, MA office with ability to work in-office the majority of the time
• Flexibility for occasional travel both domestically and internationally for trial site visits, meetings, conferences, etc. 

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