Associate Director, IT - Development, Research, CMC Business Partner
Description:
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
BBOT is seeking an experienced Associate Director, IT to serve as a strategic business partner to our Clinical Development, Research, and CMC organizations. This role will lead the oversight, optimization, and compliance of enterprise and regulated systems that support clinical execution, scientific research, manufacturing, and data-driven decision-making.
The ideal candidate brings deep expertise in GxP-regulated systems, strong experience supporting validated environments, and a proven ability to balance scientific rigor, regulatory compliance, and operational efficiency in a fast-growing oncology biotech environment.
As the work environment is dynamic and matrixed, and the organization growing rapidly, the candidate should be highly self-motivated, and be a self-starter who understands and knows how to manage deliverables to completion. The ability to work independently, establish and maintain relationships with both business stakeholders and technology counterparts will be critical to the success of this role.
Responsibilities
Clinical Development, Research & CMC Systems Partnership
• Act as the primary business systems partner for Clinical Development, Research, and CMC teams, translating scientific, operational, and analytical needs into compliant, scalable system solutions.
• Provide strategic oversight of systems supporting clinical trials, research operations, manufacturing, quality, and clinical data analysis, ensuring data integrity, traceability, and inspection readiness.
• Partner with Clinical Operations, Biostatistics, Data Management, Research, Technical Operations, and Quality to define system roadmaps aligned with development milestones.
SAS & Analytics Environments
• Lead oversight and governance of SAS environments used for clinical data analysis.
• Partner with Biostatistics, Clinical Data Management, and external vendors to support the use of SAS for analysis and reporting.
Business & Regulated Systems Leadership
• Own the lifecycle management of regulated and enterprise systems, including selection, implementation, validation, integration, and ongoing optimization.
• Ensure effective system integrations and data flows between clinical, analytical, quality, and CMC systems.
• Serve as a subject matter expert on system controls, access management, and change management in regulated environments.
Compliance & Risk Management
• Lead GxP compliance for systems supporting GCP, GMP, and GLP activities as applicable.
• Partner closely with Quality to support regulatory inspections, audits, and system-related responses.
• Develop, maintain, and enforce policies, SOPs, and controls governing validated systems, data integrity, and compliance.
Cross-Functional Collaboration
• Serve as a trusted liaison between Clinical Development, Biostatistics, Data Management, Research, CMC, Quality, IT, and external vendors.
• Provide guidance, training, and best practices to stakeholders on compliant system use.
• Influence adoption of standardized, compliant solutions across Development and CMC teams.
Continuous Improvement & Scalability
• Proactively identify system gaps, compliance risks, and opportunities to improve efficiency across Development, analytics, and CMC operations.
• Stay current on evolving regulatory expectations and industry best practices related to validated analytics and clinical systems.
Requirements:
Experience
• 8+ years of experience in business systems, regulated systems, or IT compliance within biotech, pharmaceutical, or life sciences organizations.
• Demonstrated experience supporting Clinical Development, Research, and/or CMC functions.
• Strong hands-on experience with SAS environments supporting clinical data analysis.
• Deep understanding of GxP regulations, system validation, data integrity principles, and 21 CFR Part 11.
• Experience supporting clinical, quality, manufacturing, and analytics platforms in regulated environments.
Skills & Competencies
• Strong understanding of validated analytics workflows, clinical data analysis, and system governance.
• Ability to translate scientific and analytical requirements into compliant system solutions.
• Excellent cross-functional communication and stakeholder management skills.
• Highly organized, detail-oriented, and proactive in managing compliance risk.
• Comfortable operating in a fast-paced, evolving biotech environment.
Education and Qualifications
• Bachelor’s degree required; in Life Sciences, Statistics, Computer Science, Information Systems, or a related field.
• 8+ years of relevant IT experience
• At least 1 year in an IT leadership role (Associate Director or above) and 3 or more years in an IT management role
• Strong problem-solving skills and a commitment to continuous learning and development.
• Ability to excel in a highly-collaborative and innovative environment.
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.
Apply Now
Apply Now
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
BBOT is seeking an experienced Associate Director, IT to serve as a strategic business partner to our Clinical Development, Research, and CMC organizations. This role will lead the oversight, optimization, and compliance of enterprise and regulated systems that support clinical execution, scientific research, manufacturing, and data-driven decision-making.
The ideal candidate brings deep expertise in GxP-regulated systems, strong experience supporting validated environments, and a proven ability to balance scientific rigor, regulatory compliance, and operational efficiency in a fast-growing oncology biotech environment.
As the work environment is dynamic and matrixed, and the organization growing rapidly, the candidate should be highly self-motivated, and be a self-starter who understands and knows how to manage deliverables to completion. The ability to work independently, establish and maintain relationships with both business stakeholders and technology counterparts will be critical to the success of this role.
Responsibilities
Clinical Development, Research & CMC Systems Partnership
• Act as the primary business systems partner for Clinical Development, Research, and CMC teams, translating scientific, operational, and analytical needs into compliant, scalable system solutions.
• Provide strategic oversight of systems supporting clinical trials, research operations, manufacturing, quality, and clinical data analysis, ensuring data integrity, traceability, and inspection readiness.
• Partner with Clinical Operations, Biostatistics, Data Management, Research, Technical Operations, and Quality to define system roadmaps aligned with development milestones.
SAS & Analytics Environments
• Lead oversight and governance of SAS environments used for clinical data analysis.
• Partner with Biostatistics, Clinical Data Management, and external vendors to support the use of SAS for analysis and reporting.
Business & Regulated Systems Leadership
• Own the lifecycle management of regulated and enterprise systems, including selection, implementation, validation, integration, and ongoing optimization.
• Ensure effective system integrations and data flows between clinical, analytical, quality, and CMC systems.
• Serve as a subject matter expert on system controls, access management, and change management in regulated environments.
Compliance & Risk Management
• Lead GxP compliance for systems supporting GCP, GMP, and GLP activities as applicable.
• Partner closely with Quality to support regulatory inspections, audits, and system-related responses.
• Develop, maintain, and enforce policies, SOPs, and controls governing validated systems, data integrity, and compliance.
Cross-Functional Collaboration
• Serve as a trusted liaison between Clinical Development, Biostatistics, Data Management, Research, CMC, Quality, IT, and external vendors.
• Provide guidance, training, and best practices to stakeholders on compliant system use.
• Influence adoption of standardized, compliant solutions across Development and CMC teams.
Continuous Improvement & Scalability
• Proactively identify system gaps, compliance risks, and opportunities to improve efficiency across Development, analytics, and CMC operations.
• Stay current on evolving regulatory expectations and industry best practices related to validated analytics and clinical systems.
Requirements:
Experience
• 8+ years of experience in business systems, regulated systems, or IT compliance within biotech, pharmaceutical, or life sciences organizations.
• Demonstrated experience supporting Clinical Development, Research, and/or CMC functions.
• Strong hands-on experience with SAS environments supporting clinical data analysis.
• Deep understanding of GxP regulations, system validation, data integrity principles, and 21 CFR Part 11.
• Experience supporting clinical, quality, manufacturing, and analytics platforms in regulated environments.
Skills & Competencies
• Strong understanding of validated analytics workflows, clinical data analysis, and system governance.
• Ability to translate scientific and analytical requirements into compliant system solutions.
• Excellent cross-functional communication and stakeholder management skills.
• Highly organized, detail-oriented, and proactive in managing compliance risk.
• Comfortable operating in a fast-paced, evolving biotech environment.
Education and Qualifications
• Bachelor’s degree required; in Life Sciences, Statistics, Computer Science, Information Systems, or a related field.
• 8+ years of relevant IT experience
• At least 1 year in an IT leadership role (Associate Director or above) and 3 or more years in an IT management role
• Strong problem-solving skills and a commitment to continuous learning and development.
• Ability to excel in a highly-collaborative and innovative environment.
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.
Apply Now
Apply Now