Company Overview
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving 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 expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. The company's proprietary product engine identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.
Description
The Director, Clinical Quality will lead program-level Quality Assurance (QA) oversight of clinical studies within Research & Clinical Development. This role ensures that all clinical trial activities are compliant with FDA regulations, ICH guidelines, and relevant international standards. The position will oversee Contract Research Organization (CRO) qualification and monitoring, manage departmental activities with a high degree of independence, and develop strategies to support multiple complex projects aligned with corporate goals and regulatory requirements.
As a Subject Matter Expert (SME) in GCP compliance, the Director will partner with operational stakeholders to drive quality initiatives, support regulatory inspections, and enhance quality management systems across the clinical trial lifecycle. The Director will also provide GLP and GVP oversight, with guidance from the Vice President of QA.
Responsibilities
The Director, Clinical Quality Assurance will be responsible for:
* Providing quality oversight of GCP compliance, quality systems, and related activities, including Quality Risk Management, Data Integrity, audits, and inspections.
* Advising and guiding Clinical Trial Teams on GxP compliance, best practices, and regulatory interpretations.
* Leading preparation for and management of regulatory inspections and external audits, including development of CAPA plans and lessons learned.
* Reviewing clinical trial and regulatory submission documentation for completeness and compliance.
* Developing and maintaining study-specific audit plans; providing input for investigator site audit selection, managing GCP/GCLP audits, and supporting audit responses.
* Monitoring regulatory changes and communicating impacts to QA staff and Clinical Trial Teams.
* Resolving or delegating resolution of compliance issues at clinical suppliers/sites, assessing impact of deficiencies.
* Implementing GxP-compliant procedures to strengthen the quality management system for clinical studies.
* Driving continuous improvement initiatives based on audit findings, regulatory updates, and industry best practices.
* Partnering with cross-functional teams to develop, review, and implement SOPs.
* Delivering training sessions on GCP quality and global regulations.
* Negotiating, monitoring, and maintaining Quality Agreements with CROs, as applicable.
* Supporting clinical and product commercialization activities through quality oversight.
Qualifications
* Education & Background
* Bachelor's degree in a scientific or allied health field (or equivalent).
* Minimum 10 years' experience in Quality Assurance, including internal and external auditing.
* Extensive experience with global clinical trial conduct, ICH E6(R3) GCP Guidelines, FDA regulations, and EU requirements.
* Proven experience supporting Regulatory Authority inspections.
* Experience in developing and overseeing Quality Management Systems.
* At least 2 years in a management or leadership role.
* Skills & Competencies
* Strong leadership with the ability to work independently and manage large, complex projects.
* Ability to make decisions using a risk-based approach and act with urgency.
* Ability to lead cross-functional teams and influence decision-making.
* Skilled in root cause analysis, audit processes, and CAPA development.
* Expertise in Quality Risk Management (QRM) principles and applications.
* Strong interpersonal, communication, and mentoring skills.
* Proficiency in project management tools and methodologies.
* Advanced understanding of GxP requirements across the product lifecycle.
* We offer a hybrid work model, with employees expected to be onsite at least 50% of the time.
Base Salary Pay Range
$200,000-$225,000 USD