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Director/Sr. Director Clinical Operations at Fulcrum Therapeutics, Inc. in Cambridge, Massachusetts

Posted in Other 21 days ago.

Type: Full Time





Job Description:

Company OverviewFulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients in areas of high unmet medical need. Fulcrum's proprietary patient-focused product engine is designed to systematically identify and validate cellular drug targets that can modulate gene expression to treat the root cause of genetically defined rare diseases.DescriptionReporting to the Senior Vice President of Clinical Development, this position will provide dedicated operational expertise and organizational leadership and further building of the Clinical Operations group to support multiple programs in the clinic. The ideal candidate will be motivated to lead multiple clinical programs at an innovative drug discovery and development organization and contribute to the Clinical Development Organization and lead the clinical operations group strategically and for resourcing and execution and compliance.Responsibilities* Lead the clinical operations team and oversee the strategy, planning, resourcing, execution, and close out of clinical research activities and clinical trials, data collection activities and operations.* Manages the clinical operations team that includes employees and contractors, including hiring, goal setting, performance review, training and qualifications, and career development.* Implement study protocols, data management systems, data monitoring and quality systems, and enable data analysis and data reports/publications.* Oversees efficient and timely processing of documents to support clinical development activities such as confidentiality agreements, clinical trial agreements, and vendor contracts and scopes of work.* Oversees resourcing of and execution by clinical CROs and other clinical vendors contracted to conduct clinical trials.* Oversees adherence to protocols, clinical site monitoring and audits, and determines study completion.* Responsible for clinical trial files including contracts and ethics committees and maintains clinical inventory intended for distribution to investigational sites.* Oversees compliance of the clinical trials with privacy laws in the US, EU and other Countries.* Oversees the development, training, and updates to clinical operations standard operating procedures for the organization.* Establishes and manages clinical trial budgets and monitoring of expenses versus invoices and deliverables.* Interacts with investigational sites, clinical consultants, and other vendors and leads vendor selection for clinical trials.* Maintains or develops current therapeutic area knowledge and assesses impact of new information on operational strategies.* Partners across functional lines with Regulatory Affairs, Biometrics, Clinical Development, Medical Directors, Finance, and others as needed.Qualifications* Bachelor's Degree required, with degree in the sciences preferred.* Minimum 10 years of experience in the pharmaceutical industry* Able to successfully own, manage and prioritize complex trials* Experience in more than one therapeutic area and a proven track record of leadership and project management success at the director level.* Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.* Demonstrated attention to detail and follow-through on assigned activities.* Independence; organized and adaptable to address conflicting deadlines in a dynamic drug development environment.* Outstanding interpersonal and communication (written and verbal) skills; demonstrates calm, professional, diplomatic and positive behaviors.* Strong computer skills and highly proficient in MS Office applications and Adobe Acrobat.