Associate Director/director, Clinical Operations

Associate Director/Director, Clinical Operations

Fulcrum Therapeutics, Inc. ("Fulcrum") 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).

The Associate Director/Director, Clinical Operations is a key member within Clinical Operations responsible for leading and managing clinical trials in alignment with corporate objectives and governing regulatory guidelines. This individual will play a key role in the strategic planning, development and implementation strategies of clinical trials to ensure successful and timely execution. The AD/Director will oversee CROs and vendors, and drive their successful delivery ensuring adherence to timelines, budgets, regulatory standards, and quality control. This position will report to the Head of Clinical Operations and will contribute directly to the development of a growing Clinical Operations function.

On a day-to-day basis and as the team grows you will lead and execute day-to-day clinical trial operations while working closely with the Head of Clinical Operations and Clinical Study Team to develop streamlined processes to grow and support the function and team.

The ideal candidate is an adaptable and resilient Clinical Operations leader who is interested in working in a fast-paced, dynamic, and collaborative biotech environment with a willingness and ability to contribute to the growth of the function and take on new challenges successfully. The candidate will work among a cross-functional Study Team from feasibility through study close-out. Experience in building and leading a team and processes such as Risk-Based Quality Management and Operational excellence is a plus.

You must have experience within a start-up biotech environment and be comfortable with both leading and executing all operational aspects of clinical trials while the team grows. Strong problem solving and analytical skills are necessary. As this is a lean team, you may be exposed across multiple programs at various stages of development.

In keeping with the Fulcrum culture, this position will be hybrid requiring minimum 2-day per week presence in the Fulcrum office in Cambridge, MA.

Primary Responsibilities

• Accountable for delivery of assigned clinical program/studies budget, timelines and resource management including making decisions regarding operational strategies to support study and/or program objectives
• Manage the day-to-day clinical trial operations and execution of assigned programs/studies while partnering with cross-functional teams to inform and support the broader clinical development strategy across all phases of the clinical program(s).
• Provide end-to-end oversight of trials, ensuring timely progression through all phases including initiation, enrollment, monitoring, and study closeout.
• Develop and maintain strong working relationships with internal and external stakeholders (cross-functional team members, Contract Research Organizations (CROs), external experts, and investigators), ensuring high-quality services are executed in a timely and cost-effective manner.
• Develops and drives granular Clinical Study timelines and enrollment projections and contributes to the development of Key Performance Metrics and risk mitigation strategies.
• Monitor and manage vendor and site performance, trial progress and quality through evaluation of defined study performance metrics.
• Proactively identifies risks and issues, and works with the Study Team to assess impact, devise strategies to implement corrective actions or preventive measures to mitigate risk.
• Collaborates with CRO, study vendors and cross-functional team to define and operationalize study specifications (e.g., CRO performance metrics, Central/Specialty Labs, IRT/drug supply, EDC, TMF etc.)
• Oversee and participate in the development of study documents and tools, including study protocols, consent forms, and project plans.
• Obtains and maintains an in-depth understanding of the study protocol and related procedures to contribute strongly to Study Team knowledge by sharing best practices, making recommendations for continuous improvement, and training/mentoring as appropriate.
• Assists in creating a culture of compliance by contributing to the development of practices always ensuring inspection readiness.
• Leads and/or supports Risk-Based Quality Management and Operational Excellence initiatives.
• Provides study status updates, including presentations and reports to senior management ensuring appropriate communication of risks, impact and mitigation strategies.
• Contributes to the development of the Clin Ops function; SOPs, best practices, and facilitates implementation.
• Collaborates/leads initiatives for continuous improvement projects and activities that support the development of the Clinical Team.
• Fosters an environment of continuous improvement and actively participates in the recruitment, training, and professional development of clinical operations team members.

Experience & Qualifications

Education and Certification:

• 8-10+ years of experience managing global clinical trials and study teams across all stages (startup-closeout) of phase I-III studies and a strong working knowledge of GCP/ICH and other applicable regulations/guidelines required.
• BA/BS preferably in a scientific or health-related discipline; Advanced scientific or business degree or equivalent experience desirable.

Work Experience:

• Minimum of 8-10 years of progressive experience in clinical research and drug development in the pharmaceutical industry; experience includes 7+ years of direct experience in clinical operations trial management/leadership in global trials at a sponsor company.
• Significant experience with responsible roles in the conduct or management of Phase I-III clinical trials, including but not limited to pivotal trials, first-in-human pharmacokinetic/safety trials in healthy volunteers, bioequivalence, and food effect trials.
• Experience managing a clinical program comprised of one or more clinical trials and sitting at the Global Program Team level.
• Solid experience and understanding of the challenges of navigating global study startup including the oversight of site startup processes and timelines.
• Experience across several complex therapeutic areas. Experience with rare disease therapeutic areas is required.
• Prior experience building and leading a team and processes such as Risk-Based Quality Management and Operational Excellence is a plus.
• Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
• Understand clinical study budgets, accruals and forecasting with experience liaising with Finance as required.
• Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously.
• Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships.
• Experience in vendor selection and overseeing studies being managed by a CRO.
• Strong interpersonal and relationship-building skills; ability to influence and collaborate across functions and levels.
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality).
• Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage timelines and budget.
• Detail-oriented, a self-starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment wherein all clinical trials are outsourced.
• Ability to travel to meet with potential partners and internal and external stakeholders, or to attend national and international scientific meetings and congresses. Travel will be not more than 25%.
• Ability to work in a hybrid office model.
• We offer a hybrid work environment. Team members are expected to be onsite about half of the time (50%) to support collaboration and connection.