Apogee Therapeutics
Senior Director, Head of Trial Master File (TMF)
Apogee Therapeutics, Jackson, Mississippi, United States,
Senior Director, Head of Trial Master File (TMF)
RemoteAbout Apogee TherapeuticsFounded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values:
C aring,
O riginal,
R esilient, and
E goless.If this sounds like you, keep reading!Role SummaryWe are seeking a Senior Director of TMF to serve as the Head of Trial Master File (TMF) Operations. This position is responsible for the oversight, creation, strategy, planning, resourcing, and execution of a TMF document management system for the clinical operations department. This position is responsible for cross-functional collaboration to ensure proper implementation, execution, and alignment with the company’s goals, culture, and vision. This role is accountable for developing document collection strategies and developing SOPs, training, and overall processes to ensure the TMF health and archival of clinical trial documents from both external and internal sources. The position is responsible for direct reports to manage the TMF and continue to work with IT in the evaluation and implementation of any additional technology and vendors to support documentation and training solutions for inspection readiness.Key ResponsibilitiesProvide leadership and strategic direction across Clinical Operations and study team functions to ensure the Trial Master File (TMF) processes and related documentation are of the highest quality for active in-house and outsourced studies by drawing experience with quality compliance processes and regulations such as Good Clinical & Documentation Practices.Adhere to ALCOA-CCEA principles (i.e., records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available).Develop standard reporting for ongoing compliance checks by study to be presented at the Clinical study team meetings and to management.Lead a team of direct reports that will support the TMF platforms and each study TMF.Author and review internal and external TMF-related SOPs, work instruction development, and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes, etc.) including working with the cross-functional study team to obtain necessary input.Manage the TMF processes to meet the goals and objectives of the department and maintain inspection readiness for all active studies.Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors.Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents.Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management.Support study teams in end-of-trial eTMF QC and migration activities, including study documents from all vendors.Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance.Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed.Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes.Ideal CandidateBachelor's Degree or higher.15+ years' experience leading TMF activities for clinical research/biotech/pharmaceutical.Leadership skills and experience managing employees and contractors.Experience with Veeva eTMF platform, strongly preferred.Experience with Trial Master File Reference model and good understanding of records management best practices.Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA, and EMA.Experience with Inspection readiness.Hands-on experience in a regulatory body inspection, strongly preferred.Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process.Behavioral CompetenciesExcellent attention to accuracy and detail.Effective written and verbal communication skills.Excellent presentation skills, providing information to a large audience.Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook).Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment.Ability to learn new technologies with ease.Solid analytical and proactive problem-solving skills.Strong operational skills and demonstrated ability to meet timelines.A team player with the ability to build relationships at all levels.Demonstrated self-starter with a high level of commitment.The anticipated salary range for candidates for this role will be $250,000-$280,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.What We OfferA great culture, grounded in our C.O.R.E. values:
C aring,
O riginal,
R esilient, and
E goless.Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly.Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.Flexible PTO.Two, one-week company-wide shutdowns each year.Commitment to growing you professionally and providing access to resources to further your development.Apogee offers regular all team, in-person meetings to build relationships and problem solve.
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RemoteAbout Apogee TherapeuticsFounded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values:
C aring,
O riginal,
R esilient, and
E goless.If this sounds like you, keep reading!Role SummaryWe are seeking a Senior Director of TMF to serve as the Head of Trial Master File (TMF) Operations. This position is responsible for the oversight, creation, strategy, planning, resourcing, and execution of a TMF document management system for the clinical operations department. This position is responsible for cross-functional collaboration to ensure proper implementation, execution, and alignment with the company’s goals, culture, and vision. This role is accountable for developing document collection strategies and developing SOPs, training, and overall processes to ensure the TMF health and archival of clinical trial documents from both external and internal sources. The position is responsible for direct reports to manage the TMF and continue to work with IT in the evaluation and implementation of any additional technology and vendors to support documentation and training solutions for inspection readiness.Key ResponsibilitiesProvide leadership and strategic direction across Clinical Operations and study team functions to ensure the Trial Master File (TMF) processes and related documentation are of the highest quality for active in-house and outsourced studies by drawing experience with quality compliance processes and regulations such as Good Clinical & Documentation Practices.Adhere to ALCOA-CCEA principles (i.e., records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available).Develop standard reporting for ongoing compliance checks by study to be presented at the Clinical study team meetings and to management.Lead a team of direct reports that will support the TMF platforms and each study TMF.Author and review internal and external TMF-related SOPs, work instruction development, and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes, etc.) including working with the cross-functional study team to obtain necessary input.Manage the TMF processes to meet the goals and objectives of the department and maintain inspection readiness for all active studies.Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors.Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents.Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management.Support study teams in end-of-trial eTMF QC and migration activities, including study documents from all vendors.Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance.Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed.Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes.Ideal CandidateBachelor's Degree or higher.15+ years' experience leading TMF activities for clinical research/biotech/pharmaceutical.Leadership skills and experience managing employees and contractors.Experience with Veeva eTMF platform, strongly preferred.Experience with Trial Master File Reference model and good understanding of records management best practices.Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA, and EMA.Experience with Inspection readiness.Hands-on experience in a regulatory body inspection, strongly preferred.Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process.Behavioral CompetenciesExcellent attention to accuracy and detail.Effective written and verbal communication skills.Excellent presentation skills, providing information to a large audience.Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook).Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment.Ability to learn new technologies with ease.Solid analytical and proactive problem-solving skills.Strong operational skills and demonstrated ability to meet timelines.A team player with the ability to build relationships at all levels.Demonstrated self-starter with a high level of commitment.The anticipated salary range for candidates for this role will be $250,000-$280,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.What We OfferA great culture, grounded in our C.O.R.E. values:
C aring,
O riginal,
R esilient, and
E goless.Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly.Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.Flexible PTO.Two, one-week company-wide shutdowns each year.Commitment to growing you professionally and providing access to resources to further your development.Apogee offers regular all team, in-person meetings to build relationships and problem solve.
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