Generate:Biomedicines
Associate Director, TMF Management & SOP Development
Generate:Biomedicines, Somerville, Massachusetts, us, 02145
Overview
Associate Director, TMF Management & SOP Development Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. We pursue this audacious vision because we believe in the power of generative biology to transform lives. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us. The Role: The Associate Director of TMF is responsible for the strategic leadership, operational oversight, and quality governance of the Trial Master File (TMF) process across clinical development programs. This individual ensures that TMF systems, processes, and documentation comply with applicable regulations (ICH-GCP, 21 CFR Part 11), company SOPs, and industry best practices (e.g., DIA TMF Reference Model). They will serve as the subject matter expert (SME) for all TMF-related activities, guiding internal teams and CROs to maintain inspection-ready TMFs at all times. The role also includes leadership and management of Clinical Operations SOPs to ensure consistency, compliance, and operational efficiency throughout the lifecycle of a study from start through archival, with oversight of the eTMF system and related processes, maintaining KPIs such as Quality, Completeness, and Timeliness.
Responsibilities
Lead the TMF strategy, oversight of the eTMF system, and TMF governance across clinical programs. Ensure TMF systems remain validated through release cycles and configuration changes; manage system changes to optimize workflows. Manage user access and ensure TMF data accuracy according to study needs. Develop, implement, and maintain TMF-related processes, including SOPs, forms, templates, and work instructions. Own governance of the TMF structure and oversee TMF activities at required timepoints (e.g., periodic QC reviews, completeness checks, oversight reviews). Develop training materials for TMF processes for internal and external stakeholders. Develop and maintain TMF metrics and reports to monitor KPIs (Quality, Completeness, Timeliness); identify improvement opportunities and implement solutions. Oversee QC of TMF documents, ensure timely filing, and proper review and approval. Collaborate with cross-functional teams and external stakeholders for TMF requirements; manage CRO TMFs and TMF migrations as needed. Manage TMF migration, transfer, and archival activities; participate in audits and inspections; manage the TMF budget. SOPs
Lead the development, creation, and implementation of SOPs. Collaborate cross-functionally to standardize best practices and ensure SOPs meet regulatory requirements and organizational goals. The Ideal Candidate will have
BA/BS required 7+ years of TMF experience, SOP development, and/or operations leadership In-depth knowledge of relevant regulations and GCP (ICH-GCP, 21 CFR Part 11, TMF Reference Model, clinical trial lifecycle) Proficient knowledge of CDISC Reference Model Ability to handle multiple tasks to meet deadlines Effective leadership, organization, and interpersonal skills Strong working knowledge of clinical study documentation Proficiency in Veeva Vault eTMF and Microsoft Office Suite Extensive experience with eTMF systems and CRO oversight Education
Bachelor’s degree required; life sciences or related field preferred Nice to Have (Optional)
Experience in respiratory, immunology, or rare disease trials Familiarity with IND submissions and global study execution Knowledge of clinical systems (e.g., EDC, eTMF, CTMS) Why Join Us
Join a mission-driven company revolutionizing medicine with Generative Biology. This is an opportunity to lead impactful clinical programs and shape how we deliver innovative therapies to patients. Equal Opportunity Employer Statement
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.
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Associate Director, TMF Management & SOP Development Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. We pursue this audacious vision because we believe in the power of generative biology to transform lives. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us. The Role: The Associate Director of TMF is responsible for the strategic leadership, operational oversight, and quality governance of the Trial Master File (TMF) process across clinical development programs. This individual ensures that TMF systems, processes, and documentation comply with applicable regulations (ICH-GCP, 21 CFR Part 11), company SOPs, and industry best practices (e.g., DIA TMF Reference Model). They will serve as the subject matter expert (SME) for all TMF-related activities, guiding internal teams and CROs to maintain inspection-ready TMFs at all times. The role also includes leadership and management of Clinical Operations SOPs to ensure consistency, compliance, and operational efficiency throughout the lifecycle of a study from start through archival, with oversight of the eTMF system and related processes, maintaining KPIs such as Quality, Completeness, and Timeliness.
Responsibilities
Lead the TMF strategy, oversight of the eTMF system, and TMF governance across clinical programs. Ensure TMF systems remain validated through release cycles and configuration changes; manage system changes to optimize workflows. Manage user access and ensure TMF data accuracy according to study needs. Develop, implement, and maintain TMF-related processes, including SOPs, forms, templates, and work instructions. Own governance of the TMF structure and oversee TMF activities at required timepoints (e.g., periodic QC reviews, completeness checks, oversight reviews). Develop training materials for TMF processes for internal and external stakeholders. Develop and maintain TMF metrics and reports to monitor KPIs (Quality, Completeness, Timeliness); identify improvement opportunities and implement solutions. Oversee QC of TMF documents, ensure timely filing, and proper review and approval. Collaborate with cross-functional teams and external stakeholders for TMF requirements; manage CRO TMFs and TMF migrations as needed. Manage TMF migration, transfer, and archival activities; participate in audits and inspections; manage the TMF budget. SOPs
Lead the development, creation, and implementation of SOPs. Collaborate cross-functionally to standardize best practices and ensure SOPs meet regulatory requirements and organizational goals. The Ideal Candidate will have
BA/BS required 7+ years of TMF experience, SOP development, and/or operations leadership In-depth knowledge of relevant regulations and GCP (ICH-GCP, 21 CFR Part 11, TMF Reference Model, clinical trial lifecycle) Proficient knowledge of CDISC Reference Model Ability to handle multiple tasks to meet deadlines Effective leadership, organization, and interpersonal skills Strong working knowledge of clinical study documentation Proficiency in Veeva Vault eTMF and Microsoft Office Suite Extensive experience with eTMF systems and CRO oversight Education
Bachelor’s degree required; life sciences or related field preferred Nice to Have (Optional)
Experience in respiratory, immunology, or rare disease trials Familiarity with IND submissions and global study execution Knowledge of clinical systems (e.g., EDC, eTMF, CTMS) Why Join Us
Join a mission-driven company revolutionizing medicine with Generative Biology. This is an opportunity to lead impactful clinical programs and shape how we deliver innovative therapies to patients. Equal Opportunity Employer Statement
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.
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