Associate Director/Director, Clinical Operations

@ Fulcrum Therapeutics

About Fulcrum Therapeutics

Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Their lead program, pociredir, is aimed at increasing the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).

Role Overview: Associate Director/Director, Clinical Operations

This role is responsible for leading and managing clinical trials in alignment with corporate objectives and regulatory guidelines. The position plays a key role in strategic planning, development, and execution of clinical trials. It involves end-to-end oversight including CRO and vendor management, timeline and budget adherence, and quality control.

Primary Responsibilities

• Oversee delivery of clinical programs within budget and timeline.
• Manage day-to-day clinical trial operations from startup to closeout.
• Develop study timelines, enrollment projections and risk mitigation strategies.
• Collaborate with CROs, vendors, and cross-functional teams.
• Lead initiatives in Risk-Based Quality Management and Operational Excellence.

Experience & Qualifications

Candidates must have 8-10+ years managing global clinical trials, with at least 7 years in direct clinical operations leadership. Experience in startup biotech environments, understanding of GCP/ICH regulations, and familiarity with drug development processes are required. Experience in rare disease therapeutic areas and strong analytical and problem-solving skills are essential.

Work Arrangement

This is a hybrid role requiring a minimum of 2 days per week onsite at the Cambridge, MA office.

Key skills/competency

• Clinical Trials
• Operations
• Project Management
• Compliance
• Risk Management
• Vendor Management
• Cross-functional Collaboration
• Strategic Planning
• Quality Control
• Team Leadership