SVP, Head of Technical Operations

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 is deeply committed to bringing hope and new options to patients suffering from rare hematologic diseases, and is developing a pipeline of clinical and preclinical assets. Fulcrum’s lead clinical asset is Pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. Fulcrum’s preclinical pipeline includes a novel small molecule treatment for Inherited Bone Marrow Failure Syndromes, as well as novel approaches for the potential treatment of other rare hematologic diseases. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Technical Operations team.

Description

Reporting to the CSO, the Head of Technical Operations is responsible for leading and directing all chemistry, manufacturing, and controls (CMC) activities for our clinical stage products, as well as establishing our clinical and commercial supply chain infrastructure. The qualified individual will co-develop our CMC strategy with their team of direct reports, including establishing controls and supply chains suitable for a global launch. This individual will represent TechOps on cross-functional project teams, and routinely present to the Executive Team and Board of Directors.

Key Responsibilities

• Provide executive and strategic leadership of manufacturing and supply strategies
• Together with your team and with colleagues in Quality and Reg CMC, co-develop phase-appropriate CMC strategies and tactics for our development candidates, including Ph1/2 and Pivotal stage assets
• Implement tactical plans aligned with corporate strategies to ensure that immediate and longer-term drug substance and drug product deliverables are met
• Develop and manage approaches to forecasting to ensure product supplies are on time and in location, and meet the needs of Clinical Operations
• Hire, lead and develop employees to successfully meet our objectives while balancing a highly externalized model.
• Develop strategies for commercial supply that are appropriate for a global launch in major markets, and that take into consideration a dynamic geopolitical climate
• Together with team, work closely with external manufacturing partners to ensure reliable, compliant execution against production schedules; monitor, and report performance indicators to highlight progress, risks, and mitigation strategies.
• Together with your team and colleagues, ensure performance of manufacturing sites in process validation and inspection readiness activities.
• Communicate operational status regularly to senior management and program teams

Qualifications

• M.S. or PhD in pharmaceutics preferred, or in engineering, chemistry, or analytical chemistry; MBA desirable
• Proven track record of developing phase-appropriate and timely control strategies for DS and DP, including the establishment of commercial supply chains with serialization and 3PL (or at minimum highly conversant in packaging and distribution strategies through commercial launch)
• Prior experience leading small molecule CMC activities within an emerging pharma environment
• Skilled in strategy, planning, and execution, and in the clear communication of CMC strategy and tactics to diverse audiences, including project teams and senior management
• Can serve as a thought partner/resource with colleagues in Quality and Reg CMC
• Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment; responds to stress with humor and professionalism
• Some travel required