Associate Director/Director, Clinical Operations

Third Rock Ventures • Cambridge, MA

76d • $180,000 - $230,000 • Hybrid

About The Position

Fulcrum Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. The Associate Director/Director, Clinical Operations is responsible for leading and managing clinical trials in alignment with corporate objectives and regulatory guidelines. This role involves strategic planning, development, and implementation of clinical trials to ensure successful execution. The position requires oversight of CROs and vendors, ensuring adherence to timelines, budgets, regulatory standards, and quality control. The individual will report to the Head of Clinical Operations and contribute to the growth of the Clinical Operations function. The ideal candidate is an adaptable leader interested in a fast-paced biotech environment, with experience in building and leading teams and processes such as Risk-Based Quality Management.

Requirements

• 8-10+ years of experience managing global clinical trials and study teams.
• BA/BS preferably in a scientific or health-related discipline.
• Minimum of 8-10 years of progressive experience in clinical research and drug development.
• Significant experience with responsible roles in the conduct or management of Phase I-III clinical trials.
• Experience managing a clinical program comprised of one or more clinical trials.
• Solid experience and understanding of global study startup challenges.
• Experience across several complex therapeutic areas, with a focus on rare diseases.
• Strong understanding of the drug development process, ICH guidelines/GCP.
• Demonstrated ability to lead teams in a fast-paced matrixed environment.
• Strong interpersonal and relationship-building skills.
• Excellent oral and written communication, organizational and planning skills.

Nice To Haves

• Experience in building and leading a team and processes such as Risk-Based Quality Management.
• Experience in vendor selection and overseeing studies managed by a CRO.
• Ability to travel to meet with potential partners and stakeholders.

Responsibilities

• Accountable for delivery of assigned clinical program/studies budget, timelines and resource management.
• Manage the day-to-day clinical trial operations and execution of assigned programs/studies.
• Provide end-to-end oversight of trials, ensuring timely progression through all phases.
• Develop and maintain strong working relationships with internal and external stakeholders.
• Develops and drives granular Clinical Study timelines and enrollment projections.
• Monitor and manage vendor and site performance, trial progress and quality.
• Proactively identifies risks and issues, and works with the Study Team to assess impact.
• Collaborates with CRO, study vendors and cross-functional team to define study specifications.
• Oversee and participate in the development of study documents and tools.
• Assists in creating a culture of compliance by contributing to the development of practices.
• Leads and/or supports Risk-Based Quality Management and Operational Excellence initiatives.
• Provides study status updates to senior management.
• Contributes to the development of the Clin Ops function; SOPs, best practices.
• Collaborates/leads initiatives for continuous improvement projects.
• Fosters an environment of continuous improvement and participates in recruitment and training.

Benefits

• Hybrid work environment with onsite presence expected about 50% of the time.
• Base Salary Pay Range: $180,000-$230,000 USD.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Securities, Commodity Contracts, and Other Financial Investments and Related Activities
• Education Level: Bachelor's degree