About BBOT

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com. 

Who You Are

The Senior Director, Technical Product Lead (CMC) serves as the CMC leader for one or more development programs, responsible for defining and executing the CMC strategy across all technical disciplines, including process chemistry, analytical development, formulation, manufacturing, regulatory CMC, and supply. 

This individual will partner closely with functional leads to drive progress, ensure delivery of CMC milestones, and represent CMC on the global program team. The role combines strategic vision and hands-on operational oversight, ensuring all development and manufacturing activities are aligned with program goals, regulatory expectations, and company priorities. 

Responsibilities

Strategic & Program Leadership

• Serve as the CMC representative on the cross-functional program team, accountable for CMC strategy, planning, and execution. 
• Define and maintain a phase-appropriate CMC development plan that integrates process, analytical, and formulation strategies in alignment with clinical and regulatory milestones. 
• Translate overall program objectives into actionable CMC development plans with clear deliverables, budgets, and timelines. 
• Partner with the Head of CMC and functional leads to ensure alignment across programs and effective resource planning. 
• Anticipate program risks, identify critical path activities, proactively developing contingency plans to ensure uninterrupted supply and regulatory compliance. 

Cross-Functional Team Execution

• Partner with functional leads of Process Chemistry, Analytical Development, and Formulation to ensure all technical workstreams are progressing according to plan, with clear deliverables and interdependencies. 
• Lead regular cross-functional CMC team meetings to track activities, coordinate workstreams, review progress, identify risks, drive decision-making, and resolve technical or operational challenges. 
• Ensure timely communication of progress, issues, and mitigation strategies to the program team, governance committees, and senior management. 
• Collaborate closely with Regulatory Affairs and Quality to ensure CMC documentation supports filings and inspections. 

Technical & Operational Leadership

• Provide scientific and technical guidance across process, analytical, and formulation disciplines, ensuring sound scientific rationale and regulatory compliance. 
• Oversee external manufacturing and testing partner steering committees, ensuring quality, timelines, and cost targets are met. 
• Identify and mitigate CMC risks and implement proactive contingency plans. 

Leadership & Communication

• Lead the CMC team for assigned programs, fostering strong collaboration, accountability, and transparent communication. 
• Provide mentorship and guidance to CMC functional team members and project managers. 
• Actively contribute to CMC organizational strategy and continuous improvement initiatives.  
• Work with CMC Project Manager and functional leads to ensure appropriate resourcing and budget development by strategic assessment of milestones and corresponding resource requirements, while providing periodic review of forecasted expenditures. Communicate to assess and confirm appropriate allocation and use of resources. 
• Work with the CMC Project Manager and team to build and review monthly program updates to the Program Development Team and Quarterly Review Board to ensure transparency of progress and guide essential program decisions. 

Education and Qualifications

• Advanced degree (Ph.D. or M.S.) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline. 
• 12+ years of progressive CMC experience in the biopharmaceutical industry, with a strong record of leadership across multiple technical functions. 
• Proven experience leading cross-functional CMC teams from early development through late stage or commercial readiness. 
• Deep understanding of regulatory expectations (FDA, EMA, ICH) and global submission requirements. 
• Demonstrated ability to manage complex projects, multiple stakeholders, and external partners. 
• Excellent leadership, communication, and organizational skills with a proactive, solution-oriented mindset. 
• Ability to work in a fast-paced, matrixed, and externalized environment. 
• Successful participation in IND and NDA/BLA submissions. 
• Experience in a lean, cross-functional biotech environment balancing strategic and hands-on responsibilities.

Why Join Us?

Join a fast-paced, mission-driven biotech team focused on delivering transformational therapies 

Competitive salary, benefits, and meaningful equity participation in a company entering the public market 

Compensation

BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.  

Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.