Associate Director, Clinical Operations
Larimar Therapeutics, based in the Philadelphia area, is committed to discovering and developing treatments for complex rare diseases, with an initial focus on Friedreich's ataxia. Its proprietary protein replacement therapy platform is intended to deliver missing proteins inside the machinery of cells to treat devastating rare diseases that currently have ineffective or no treatments available.
This position reports to the Vice President, Clinical Operations and will be responsible for the execution and reporting of clinical trial activities, ensuring adherence to study timelines, budgets, quality plans, and relevant ICH/GCP Guidelines.
Will include but are not limited to:
• Writes and/or reviews protocols, protocol amendments, informed consent forms, annual reports, and submission documents.
• Participates in the development of outsourcing strategies, including the evaluation and selection of CRO's and vendors.
• Manages/monitors clinical study activities and execution by the CRO's/vendors through adherence to study timelines and established metrics.
• Participates in the review and/or generation of all relevant study documents, tools, plans, guidelines, and specifications, including but not limited to EDC, monitoring plans, study management and oversight plans, IWRS specifications, etc.
• Understands and tracks study monitoring/management metrics and understands core concepts of Risk Based Monitoring.
• Development and management of clinical trial finances including study budgets, service contracts, investigator grants, accruals, and forecasting.
• Accountable for ensuring that all studies are carried out according to the study protocol, SOPs and applicable ICH/GCP guidelines.
• Participates in inspection readiness activities and audit activities; works with the quality department to ensure that all corrective and preventative actions are implemented.
• Participates in quality and process improvement initiatives as necessary.
Education, Experience, Skills and Knowledge:
Requires a B.A./B.S. in life sciences or healthcare (advanced degree preferred) and a minimum of 7 years of relevant drug development experience in the pharmaceutical/biotechnology industry. Experience in clinical trials (Phase 1 through 3) required, with experience in rare diseases, oncology, or neuroscience drug development preferred. The successful candidate will have the ability to partner with Patient Advocacy Groups and thorough knowledge of ICH/GCP guidelines, clinical trial design, and regulatory processes. If you have demonstrated vendor and project management experience and are able to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions, this may be the opportunity for you!