Atlas Venture
Associate Director / Director, Study Trial Master File
Atlas Venture, Bala Cynwyd, Pennsylvania, United States, 19004
Associate Director / Director, Study Trial Master File
Company Address:
Three Bala Plaza East, Suite 506, Bala Cynwyd, PA 19004, US
Overview Larimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN) to patients with Friedreich’s ataxia.
We are a team with extensive pharmaceutical experience across discovery, non-clinical and clinical development, regulatory affairs, manufacturing, and CMC. We pursue a patient-focused strategy to lead in the treatment of rare diseases through our cell-penetrating technology platform, with an entrepreneurial and scientific leadership culture.
Position Details Job Title:
Associate Director / Director, Study Trial Master File (TMF)
Travel:
Approximately 10% (domestic/international)
Reports to:
Chief Development Officer (initially)
Location:
Onsite at least two days per week in Bala Cynwyd, PA (hybrid work model)
Responsibilities TMF Oversight & Compliance
Serve as the TMF lead for a global clinical trial, fully accountable for the accuracy, completeness, and regulatory compliance of the Trial Master File from study start-up through final archival.
Develop, update, and deliver TMF processes, procedures, and training in alignment with industry best practices and regulatory requirements.
Lead the TMF plan and build study eTMF and ensure completeness accordingly.
Ensure TMF documentation is consistent with specifications, internal SOPs, and applicable regulatory guidelines (ICH GCP, FDA, EMA, and other country-specific requirements).
Maintain TMF inspection- and submission-readiness throughout the trial lifecycle, monitoring quality and implementing corrective actions when necessary.
Act as the primary point of contact for all TMF-related activities, queries, and decisions for the trial.
Stay current with regulatory changes and translate them into actionable process improvements.
Process Management & Quality Control
Conduct ongoing quality control reviews of TMF content to ensure accuracy, timeliness, and compliance.
Establish and monitor TMF performance metrics, identify documentation gaps, and drive remediation and continuous improvement strategies to senior leadership.
Drive continuous improvement in TMF operations, including CAPAs and lessons learned.
Travel domestically and internationally (~10%) for vendor oversight, study team meetings, audits, or inspections.
Cross-Functional Collaboration
Work with clinical operations, regulatory affairs, quality assurance, and other stakeholders to support timely and accurate documentation filing.
Lead TMF-related communications with study teams, ensuring alignment on responsibilities, timelines, and expectations.
Support inspection readiness activities, including internal reviews, mock inspections, and audit preparation.
Manage external vendors, CROs, and internal stakeholders to ensure TMF standards and timely document flow.
Serve as the business owner of the eTMF system for the study, including configuration, access controls, and change management.
Oversee records management for the trial, including off-site storage and archival, ensuring compliant chain-of-custody practices.
Inspection Readiness & Regulatory Support
Ensure the TMF is prepared for regulatory inspection at any point during the trial.
Lead TMF reviews and remediation efforts in preparation for audits or inspections.
Assist with audit response and CAPA development as needed.
Other Responsibilities
Perform related duties as necessary or as assigned
Qualifications
Minimum of 15+ years of relevant industry experience with a Bachelor’s degree, or 10+ years with a postgraduate degree.
Experience managing TMF for global clinical trials including direct vendor oversight.
Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms.
Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and best practices for TMF operations.
Strong knowledge of the DIA TMF Reference Model and its application in operational settings.
Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities.
Exceptional communication skills and the ability to collaborate across cross-functional teams.
Highly skilled in project management, with the ability to oversee multiple initiatives, set priorities, and meet deadlines.
Proven problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment.
Ability and willingness to work onsite at least two days per week, in a hybrid work model.
Benefits & EEO Larimar Therapeutics offers a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.
We are committed to equal-employment principles and strive to recruit and employ highly qualified individuals representing diverse communities. Employment decisions are based on merit, qualifications, performance, and business needs, without discrimination.
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Company Address:
Three Bala Plaza East, Suite 506, Bala Cynwyd, PA 19004, US
Overview Larimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN) to patients with Friedreich’s ataxia.
We are a team with extensive pharmaceutical experience across discovery, non-clinical and clinical development, regulatory affairs, manufacturing, and CMC. We pursue a patient-focused strategy to lead in the treatment of rare diseases through our cell-penetrating technology platform, with an entrepreneurial and scientific leadership culture.
Position Details Job Title:
Associate Director / Director, Study Trial Master File (TMF)
Travel:
Approximately 10% (domestic/international)
Reports to:
Chief Development Officer (initially)
Location:
Onsite at least two days per week in Bala Cynwyd, PA (hybrid work model)
Responsibilities TMF Oversight & Compliance
Serve as the TMF lead for a global clinical trial, fully accountable for the accuracy, completeness, and regulatory compliance of the Trial Master File from study start-up through final archival.
Develop, update, and deliver TMF processes, procedures, and training in alignment with industry best practices and regulatory requirements.
Lead the TMF plan and build study eTMF and ensure completeness accordingly.
Ensure TMF documentation is consistent with specifications, internal SOPs, and applicable regulatory guidelines (ICH GCP, FDA, EMA, and other country-specific requirements).
Maintain TMF inspection- and submission-readiness throughout the trial lifecycle, monitoring quality and implementing corrective actions when necessary.
Act as the primary point of contact for all TMF-related activities, queries, and decisions for the trial.
Stay current with regulatory changes and translate them into actionable process improvements.
Process Management & Quality Control
Conduct ongoing quality control reviews of TMF content to ensure accuracy, timeliness, and compliance.
Establish and monitor TMF performance metrics, identify documentation gaps, and drive remediation and continuous improvement strategies to senior leadership.
Drive continuous improvement in TMF operations, including CAPAs and lessons learned.
Travel domestically and internationally (~10%) for vendor oversight, study team meetings, audits, or inspections.
Cross-Functional Collaboration
Work with clinical operations, regulatory affairs, quality assurance, and other stakeholders to support timely and accurate documentation filing.
Lead TMF-related communications with study teams, ensuring alignment on responsibilities, timelines, and expectations.
Support inspection readiness activities, including internal reviews, mock inspections, and audit preparation.
Manage external vendors, CROs, and internal stakeholders to ensure TMF standards and timely document flow.
Serve as the business owner of the eTMF system for the study, including configuration, access controls, and change management.
Oversee records management for the trial, including off-site storage and archival, ensuring compliant chain-of-custody practices.
Inspection Readiness & Regulatory Support
Ensure the TMF is prepared for regulatory inspection at any point during the trial.
Lead TMF reviews and remediation efforts in preparation for audits or inspections.
Assist with audit response and CAPA development as needed.
Other Responsibilities
Perform related duties as necessary or as assigned
Qualifications
Minimum of 15+ years of relevant industry experience with a Bachelor’s degree, or 10+ years with a postgraduate degree.
Experience managing TMF for global clinical trials including direct vendor oversight.
Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms.
Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and best practices for TMF operations.
Strong knowledge of the DIA TMF Reference Model and its application in operational settings.
Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities.
Exceptional communication skills and the ability to collaborate across cross-functional teams.
Highly skilled in project management, with the ability to oversee multiple initiatives, set priorities, and meet deadlines.
Proven problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment.
Ability and willingness to work onsite at least two days per week, in a hybrid work model.
Benefits & EEO Larimar Therapeutics offers a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.
We are committed to equal-employment principles and strive to recruit and employ highly qualified individuals representing diverse communities. Employment decisions are based on merit, qualifications, performance, and business needs, without discrimination.
#J-18808-Ljbffr