Apogee Therapeutics

Director

• Provide leadership and act as a Subject Matter Expert (SME) for TMF operations and requirements across study team functions, CROs, and vendors to ensure TMF content is timely, complete, and of the highest quality for in-house and outsourced studies
• Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner
• Serve as an escalation point for study teams to drive resolution of issues, as appropriate
• Ensure compliance with TMF Management SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available), applicable regulations, GCP requirements, and industry standards
• Monitor and report KPIs to senior management, identifying trends across the portfolio, areas for improvement, and implementing changes as needed
• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required
• Responsible for the management and leadership of a team of direct reports that will support the eTMF platforms and each study TMF including recruitment, training, mentoring, career development, work assignments, performance evaluations, and ongoing feedback
• Assist with development and implementation of TMF processes, procedures, supporting tools, and TMF-related training materials that adhere to regulatory requirements and industry best practices
• Review external TMF-related SOPs and associated documentation as needed
• Author and review TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.), working with the cross functional study team to obtain necessary input
• Oversee study teams in TMF closeout activities, including collection of study records from all vendors, end of trial TMF QC, and migration activities, if applicable
• Oversee archiving activities to ensure adherence to processes and industry best practices
• Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with start-up activities, record collection and processing, QC, and/or archiving, as needed
• Collaborate on projects with Information Technology (IT) to ensure effective implementation and integration of eTMF clinical systems
• Lead and manage resolution of issues and remediation activities with stakeholders and the eTMF vendor
• Serve as eTMF Business Owner and Administrator
• Support integration of partnered or clinical information including TMF transfers in compliance with applicable regulations and best practice
• Provide eTMF system training and acts as a primary support for users and study teams
• Assist management with identifying areas of improvement and enhancements and obtains approval for system development projects

Associate Director, TMF Management

Procurement

• Develop and implement an enterprise-wide strategic sourcing and procurement framework that encompasses best in class processes for vendor sourcing, selection, qualification, risk assessment, onboarding, performance management, and lifecycle governance, ensuring alignment with business objectives, regulatory requirements, and quality standards
• Develop and implement end-to-end procurement strategies and processes, including aligning procurement activities with the overall business goals and objectives
• Oversee procurement operations, ensure efficiency, cost-effectiveness, and compliance with company policies and regulations and ensure that all procurement activities are conducted efficiently and effectively, from requisition to payment
• Manage the RFPs/RFQs/RFIs process, review materials in partnership with business stakeholders and legal
• Negotiate contracts to secure favorable terms and conditions for the company in partnership with functional business partners and legal
• Identify, evaluate, and select partners that are qualified to meet Apogee’s needs in terms of cost, quality, delivery, and innovation
• Develop criteria for and manage Apogee’s preferred vendor list
• Conduct spend analysis across functional areas to gain a comprehensive understanding of spending patterns, supplier performance, and potential cost-saving opportunities
• Build and maintain strong relationships with key suppliers, fostering collaboration and ensuring quality and reliability, manage performance and taking corrective action when necessary
• Monitor and analyze procurement performance, track key performance indicators (KPIs) to identify areas for improvement and drive continuous improvement
• Ensure that all procurement activities are conducted within functional budget constraints
• Ensure compliance with all relevant laws, regulations, and company policies
• Stay informed about the latest trends and technologies in the strategic sourcing and procurement industry and share knowledge across the company

Head of Strategic Sourcing – Procurement

Business Development Rep

• Track, analyze, and interpret competitive developments relevant to Apogee’s programs
• Attend key scientific and medical conferences
• Collaborate with other functions to support Apogee’s programs and business objectives
• Support the Executive Team to help develop and communicate the corporate strategy
• Execute strategic analyses on behalf of the Executive Team and Board of Directors
• Identify and conduct due diligence on new targets and in-licensing opportunities
• Support business development and partnering discussions

Associate Director, Business Development – Strategy

Payroll

• Support the payroll team with end-to-end payroll processing, including regular and off-cycle payrolls in accordance with SOX internal controls and company policies
• Work closely with the payroll and people team to ensure accurate and timely processing of new hires, terminations, and employee data changes
• Respond to employee payroll inquiries and provide timely issue resolution and service
• Perform payroll reconciliations and ad hoc reporting to support audits, management requests, and payroll-related projects
• Assist with year-end and month-end payroll activities, including W-2 preparation and reconciliation
• Maintain payroll documentation and ensure confidentiality and data integrity
• Assist with and reconcile equity compensation transactions into payroll and perform YTD wage reconciliations
• Help resolve payroll tax notices by researching discrepancies and coordinating any amendments and responses
• Other ad-hoc duties as assigned

Payroll Analyst

IT Support

• Propel effective delivery of IT Infrastructure services like Microsoft Entra, Intune, M365/Teams, Azure, Smartsheet, Zoom, IAM, and disaster recovery, through both your own technical ability and through working with others. Foster a collaborative and customer-service-focused culture within the team and with our MSP-based Helpdesk and SOC teams.
• Work closely with IT peers as well as business teams to understand their needs and develop solutions that support business goals. Facilitate communication and collaboration between IT and other teams.
• Ensure exceptional customer service and user experience by implementing best practices and continuous improvement processes. Address and resolve Infrastructure issues promptly and effectively.
• Design and implement solutions that enhance user experience and meet the evolving needs of the company. Continuously monitor and improve IT systems to ensure optimal performance.
• Provide strong project management leadership, prioritizing tasks and managing resources effectively to meet deadlines and objectives. Steer IT infrastructure projects from inception to completion, ensuring they are delivered on time, within scope, and with high quality. Utilize project management methodologies to manage resources and timelines.
• Build knowledge of how our business and industry operate, to build and deliver Infrastructure solutions that maximally boost company effectiveness.
• Partner with IT team members to execute the organization’s technology strategy, aligned with company goals, the biotech industry's best practices, and regulatory requirements. Stay informed of industry trends and emerging technologies to ensure the company's IT infrastructure remains competitive and innovative.
• Manage relationships with external vendors and service providers, ensuring they deliver high-quality services and support. Negotiate contracts and agreements to achieve the best value for the company. Ensure the delivery of superior results within the terms of various SOWs. Manage requirements and expectations within project constraints.

Associate Director, IT Infrastructure Operations

• Author internal raw materials testing specifications, specifically for non-compendial raw materials
• Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation
• Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites
• Review and assess impact of vendor change notifications related to GMP raw materials; partner with internal and external stakeholders to development plans for material changes with major impact
• Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing; may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management
• Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required
• Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing

Associate Director, QC Manufacturing Support

• Partner with Legal Department members to assist with the drafting, negotiation and management of a high volume of contracts for clinical, research, quality, manufacturing, commercial and other internal business partners, including clinical trial agreements, master services agreements, consulting agreements, confidentiality agreements, research agreements and other business agreements
• Act as a liaison between internal business partners, the Legal Department, external vendors and outside counsel as necessary to facilitate contract implementation, renewals, and terminations
• Continue to improve the internal contracting process, including assisting with the administration of our integrated contracts management system, developing internal training materials related to the contracting process and identifying steps to increase efficiency
• Help develop and implement new policies, procedures and contract templates and provide related education and training to internal clients
• Work closely with members of finance and other departments to help ensure compliance with cross-functional policies and procedures
• Develop reports, presentations, spreadsheets, memos and other documents for the Legal Department, internal clients and/or the senior management team
• Review clinical study informed consent forms and related documents as needed
• Assist with completion, review and validation of needs assessment forms in connection with HCP engagements, including to confirm alignment with fair market value and contractual terms
• Identify legal, documentation gaps and contractual risks and escalate matters in accordance with protocols and guidance
• Provide practical contracts support to internal clients during contract preparation and negotiation
• Complete special projects as requested, such as conducting research and collaborating on department-wide or company-wide initiatives

Associate Director, Contracts

Clinical Operations

• Manage and plan CTO resourcing for assigned programs
• Lead, build and mentor CTO team supporting assigned program(s)
• Serve as a member on Clinical Operations Leadership Team (COLT)
• Create and support implementation of Clinical Operations processes, platforms and/or systems
• Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs, ensuring clinical operations strategic and operational input to clinical development programs
• Clinical operations representative on Program Teams (PT)
• Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
• Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans, when necessary
• Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
• Strong collaboration and partnership with cross functional colleagues globally (e.g., Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc.) to ensure on-budget, timely, high-quality delivery of the programs
• Monitor the progress of projects and provide senior management with timely updates, changes in scope and resource requirements across the assigned clinical program(s)
• Work cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Serve as the central point of contact and contribute expertise for clinical trial execution on assigned protocols
• Ensure accurate tracking/reporting (dashboard) of study metrics and progress of study through completion
• Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Develop, review and/or consult on clinical trial documents, such as informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
• May be responsible for participating/presenting at Investigator Meetings, SIVs and other meetings
• Accountable for program level clinical operations budget forecasting, accrual management and quarterly review, ensuring tight control between study forecasts and actuals
• In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc
• Review and approve contracts, work orders and invoices prior to submission to Executive approval
• Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs) in partnership with Clinical Business Operations
• Demonstrate consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors
• Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others, as necessary, to assure alignment and achievement of study goals
• Draft and/or manage Governance charters/meetings/reports with CRO
• Responsible for managing relationships with CROs and other vendors for all study activities, including study start-up, close out, completion of Trial Master File and the following:
• Setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to oversee scope change negotiations
• Negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO
• Patient recruitment and retention plans
• Set-up of all third-party vendor specifications (i.e., IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables
• In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB//Ethics submission prior to study start-up
• Collaborate with Clinical Supply to assure sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study
• In conjunction with CRO, accountable for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study
• In conjunction with CRO, accountable for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.)
• Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Oversees routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files
• Partner with Quality organization to document Sponsor Oversight of all vendors, data integrity, and risk assessment requirements
• Participate and respond to Quality Assurance and/or regulatory authority inspection audits
• Ensure all assigned protocols are always inspection ready
• Accountable for working closely with Biometrics, Pharmacovigilance and the CRO to oversee data cleaning and review, and oversee adherence to study timelines and data quality.
• In conjunction with the CRO, oversee and drive the metrics on CRA source data verification

Executive Director – Global Clinical Operations

QA Engineer

• Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs
• Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision
• Act as CQA lead representative at clinical study team meetings and other study related meetings
• Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP
• Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence
• Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned
• Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization
• Assist in the development and/or delivery of GCP training topics and quality standards as directed
• Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals
• Collaborate with clinical functions to support inspection readiness activities
• Perform key activities during regulatory authority inspection and/or external audits as directed by Head of CQA

Associate Director, Clinical Quality Assurance

• Accountable for overall management of multiple clinical trials
• Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
• Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
• Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
• Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Responsible for preparing and/or presenting to executive management as delegated
• Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
• May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
• Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
• In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc
• Review and approve contracts, work orders and invoices prior to submission to senior management for approval
• Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs)
• Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors
• Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
• Draft and/or manage Governance charters/meetings/reports with CRO
• Co-lead Sponsor/CRO operational meetings with CRO to ensure deliverables are on track
• Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, completion of Trial Master File and the following:
• Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to oversee scope change negotiations
• Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO
• Responsible for patient recruitment and retention plans
• Responsible for the set-up of all third-party vendor specifications (i.e. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables
• In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB/Ethics submission prior to study start-up
• In conjunction with Clinical Supply, responsible for assuring sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study
• Responsible for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study
• In conjunction with CRO, responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.)
• Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files
• Partner with Quality organization to document Sponsor Oversight of all vendors, Data Integrity, and Risk Assessment requirements
• Participates and responds to Quality Assurance and/or regulatory authority inspection audits
• Ensures all assigned studies are always Inspection Ready
• Accountable for working closely with Biometrics, Pharmacovigilance, Medical, and the CRO to participate in data review, and oversee adherence to study timelines and data quality. Oversight includes the following activities: expedited query resolution, support creation of logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. Oversight of protocol deviations/variations
• In conjunction with the CRO, oversee and drive the metrics on CRA source data verification.

Associate Director, Clinical Operations

• Manage document control activities within the electronic document management system (EDMS) (i.e., Veeva Quality Suite)
• Maintain document control policies, procedures, and systems in accordance with GXP regulations
• Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training
• Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records
• Conduct regular audits (“data cleaning”) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and “system wellness.”
• Maintain robust quality control measures for all GXP documents
• Leverage experience with Veeva Systems to optimize document management processes and workflows
• Provide guidance and training to staff on using Veeva for document control and compliance purposes
• Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH)
• Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance
• Identify opportunities for improvements in GXP document and record control practices

QA Document Control Specialist

Supply Chain

• Oversee and execute global import and export activities in compliance with applicable trade regulations, including management of licenses, permits, and country-specific requirements.
• Act as Importer of Record (IoR) when required, ensuring full compliance with statutory obligations and recordkeeping requirements.
• Ensure internal procedures and broker practices remain aligned with evolving regulatory requirements.
• Prepare, review, and maintain shipping documentation, ensuring inspection-ready archiving and recordkeeping.
• Manage domestic and international logistics for cell banks, drug substance (DS), drug product (DP), and devices, ensuring timely and compliant delivery across the global clinical supply network.
• Ensure real-time shipment visibility and timely resolution of logistics deviations, including delays, temperature excursions, and customs issues.
• Establish, qualify, and maintain compliant logistics lanes, shipment models, and escalation pathways.
• Build and manage a network of freight forwarders, couriers, and customs brokers, including sourcing, evaluation, selection, onboarding, and performance management.
• Oversee GMP and Non-GMP inventory management, including tracking, reconciliation, and control across CMOs, depots, laboratories or other required sites.
• Establish and oversee periodic inventory verification and review activities to ensure inventory accuracy, compliance and destruction as appropriate.
• Investigate and resolve inventory discrepancies in partnership with Quality, CMOs, and internal partners.
• Ensure logistics and inventory activities comply with GMP, GDP, GxP, and internal SOPs; support audits and regulatory inspections.
• Partner with Quality on deviation investigations, root cause analysis, and CAPA implementation related to logistics, inventory, or trade compliance.
• Perform Clinical Supply Chain activities, such as, but not limited to, study level forecasting and planning, packaging and labeling and/or finished goods distribution.
• Develop and maintain SOPs, work instructions and reporting to support operational excellence and scalability.
• Maintain Supply Chain Management metrics and KPIs to support internal reporting and external reporting for vendor oversight/governance

Logistics & Inventory Manager, Supply Chain Management

Vice President

• Lead the strategic planning and execution of biomarker discovery and development programs for inflammatory and immunology diseases, focusing on atopic dermatitis, asthma, COPD and EOE and particularly late-stage clinical development
• Develop and articulate the late-stage clinical and post-launch strategic vision for the biomarker programs to internal and external stakeholders
• Collaborate with internal and external stakeholders to integrate our biomarker discovery and development efforts into our development programs, including clinical trials and BLAs
• Oversee the Biomarker Discovery and Development team to drive efforts through a combination of in vitro/in vivo and in silico data analyses, in house and in collaboration with external partners
• Together with the Senior Director-Biomarker Discovery and Development develop and implement biomarker strategies to demonstrate the clinical utility of novel biomarkers and the distinction of patient populations and responders as well as additional indications
• Stay current on emerging trends and technologies in biomarker discovery and development, and implement best practices to ensure the success of our programs
• Provide strategic input and leadership to cross-functional program and functional teams to drive the development of novel, innovative therapies for inflammatory and immunology diseases

Vice President – Inflammatory and Immune Disease Biomarker Development

• Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams
• Develop late-phase and commercial launch strategy for PFS development and manufacturing
• Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support
• Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members
• Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness
• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
• Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies
• Analyze manufacturing data and identify opportunities for process improvement and optimization
• Support formulation and co-formulation development for protein therapeutics, including antibodies
• Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
• Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Director, Drug Product Development

• Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations.
• Partner with global and cross-functional teams to ensure successful implementation of harmonized methods.
• Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements.
• Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues.
• Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines.
• Generate and review technical documents, including protocols, reports, and method lifecycle documents.