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Associate Director of Clinical Science

On-site Full-time $170K/yr - $195K/yr

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Experience Level

Senior Level Manager

Qualifications

Collaborate with the Medical Director to develop comprehensive clinical development strategies. Engage with patient advocacy groups, external investigators, and other key stakeholders on Natural History and biomarker studies. Contribute to the design of clinical trials and the writing/reviewing of essential study documents, including protocol concepts, full study protocols, Investigator Brochures, IND submissions, and Clinical Study Reports. Support the organization of expert panels and advisory board meetings to gather insights for the clinical plan, study design, or data interpretation. Lead action-oriented project team meetings and periodic project reviews, setting agendas and ensuring actionable minutes are documented. Proactively anticipate risks and collaborate with the Medical Director, Project Manager, and other team members to manage and mitigate these risks. Oversee the execution of clinical trials, ensuring all clinical activities are conducted in compliance with regulatory standards.

About the job

Fulcrum Therapeutics is an innovative clinical-stage biopharmaceutical organization dedicated to enhancing the quality of life for patients suffering from genetically defined rare diseases that exhibit a significant unmet medical need. Our proprietary product engine is adept at identifying drug targets capable of modulating gene expression to address the underlying causes of gene misexpression. We are currently advancing our flagship asset, FTX-6058 (pociredir), a small molecule engineered to elevate fetal hemoglobin expression for the treatment of sickle cell disease and beta thalassemia.

Position Summary

The Associate Director of Clinical Science will collaborate closely with the Executive Medical Director and VP of Clinical Development to provide critical support across one or more Clinical Project Teams at Fulcrum Therapeutics. This role is pivotal in ensuring the effective design and execution of Clinical Development Plans, focusing on crafting cost-efficient clinical trials that fulfill the needs of both internal and external stakeholders.

The successful candidate will assume responsibility for the scientific oversight of clinical studies, working in partnership with study program leadership and cross-functional team members. This includes the interpretation and communication of clinical trial data, which are crucial for high-quality regulatory submissions. Key responsibilities encompass contributing to the design and execution of company-sponsored clinical trials at all developmental phases, analyzing clinical trial data, and facilitating internal and external communications regarding project plans and progress. The Associate Director will also be involved in safety monitoring and mitigation strategies, as well as making significant contributions to regulatory submissions, publications, and communications of clinical data.

About Fulcrum Therapeutics

Fulcrum Therapeutics stands at the forefront of biopharmaceutical innovation, committed to addressing the needs of patients with rare genetic diseases. Our mission is to leverage our proprietary technology to transform the treatment landscape for these underserved patient populations, providing hope and improved outcomes through our advanced therapeutic solutions.

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