Company Overview
Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).
Description
Description
Reporting to Vice President of Clinical Development, The Senior Director, Clinical Operations will be responsible for clinical operations strategy and execution at Fulcrum Therapeutics. The ideal candidate will be expected to lead and support the clinical operations team in the implementation and oversight of clinical studies, focusing on area of clinical operational strategy, study logistics, planning, and execution, as well as reporting of a complex clinical study and/or program. This role will be a critical interface between Fulcrum, vendors, and study sites.
Responsibilities
- Lead the Clinical Operations Study Team and serves as the point of contact for study(ies) execution
- Direct input into the clinical program development strategy
- Oversees/Manages CROs, vendors, and consultants involved with the clinical studies
- Establishes study timelines in line with company goals and ensures accurate tracking and reporting of study metrics and progress through completion of study dashboards
- Works cross-functionally to ensure clinical operations program timelines and goals are met and risks are appropriately escalated VP of Clinical Development
- Ensures study adherence to ICH/GCP/Federal and local regulations and company specific SOPs
- Develops, reviews and/or consults on reports and clinical study documents such as informed consent forms, clinical protocols, Investigator Brochure, routine updates to the regulatory authorities and Ethics Committees, and study status updates
- Responsible for communication and escalation of study related issues to the VP Clinical Development
- Provides enrollment forecasting to internal stakeholder agreed upon frequency
- Oversees or conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed
- Participates and responds to Quality Assurance and/or regulatory authority inspection audits
- In conjunction with CRO/vendors/consultants and appropriate internal stakeholders, facilitates the development and negotiation of trial budgets and execution of clinical trial agreements and other relevant documents
- Manages the clinical program trial budget and provides financial reporting and projections to Finance
- Leads creation of scope of work and budgets and escalates vendor performance issues to VP Clinical Development as necessary
- Participates in operational improvement initiatives (e.g., SOP development, training, etc.)
- Mentors junior team members and ensures alignment with any supporting study leads assigned to studies
- May have direct report(s)
Qualifications
Minimum 10+ years experience in global clinical trial management roles. Prior management of Ph. 2 and pivotal trials requiredIn-depth understanding and experience across clinical operations with a track record of success in study planning, execution, data cleaning, database locking, study report generation, and regulatory inspection preferredExperience with developing protocols, Clinical Study Reports, Informed Consent Forms, as well as other clinical, regulatory, and safety documents preferredUnderstanding and knowledge of current industry regulations and guidelinesStrong organizational/communication skills and attention to detail, with the ability to lead and motivate teams and collaborate effectively across functionsAbility to work independently and exercise critical thinkingExperience with EDC, IRT, and other study-related platformsMonitoring experience a plusWilling to perform other work-related duties as assigned.Bachelor’s Degree, in nursing, life sciences or related field preferredWilling to travel, domestically and internationally (
