Apogee Therapeutics

Clinical Operations

• Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team
• Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation
• Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CROs
• Collaborate with Apogee Process Excellence and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness
• Oversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization
• Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organization
• Develop, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globally
• Collaborate with cross functional Clinical Study Team members to develop end-to-end clinical operations process, tools and resources
• Collaborate with Clinical Study Team members and CRO to develop necessary standard practices to meet clinical trial country specific operational requirements
• Lead and participate in key process improvement initiatives to ensure continuous process improvement
• Lead any assigned departmental activities to support a highly functioning Clin Ops organization

Associate Director, Clinical Operations Standards – Planning

Supply Chain

• Manage the end-to-end clinical supply chain for multiple clinical programs, ensuring the timely and efficient delivery of investigational products, comparators, and ancillary supplies to support global clinical studies.
• Collaborate closely with cross-functional teams including Clinical Operations and Development, Regulatory Affairs, Manufacturing, Quality, and external partners to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards.
• Develop and implement clinical supply strategies to meet study timelines for complex programs that require multinational interactions by reviewing clinical trial synopsis’ and/or protocols to understand IMP supply and demand requirements.
• Prepare demand forecast(s) using simulation and/or forecasting tools, ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered.
• Partner with Clinical Operations and other stakeholders to determine demand assumptions, such as number of patients and clinical sites, countries/regions, enrollment rates, etc.
• Collaborate with manufacturing to develop drug product delivery schedules to meet demand.
• Optimize supply chain operations to minimize waste and ensure availability of investigational medicinal products (IMP) and materials while maintaining a low risk profile.
• Establish SOP’s and work instructions required to manage clinical supply.
• Oversee the procurement, packaging, labeling, distribution, and return of clinical trial materials, ensuring quality standards and regulatory compliance.
• Manage the label development process.
• Manage vendor relationships for outsourced supply chain services, including distribution centers, packaging vendors, and courier services.
• Develop IRT User Requirement Specifications and conduct User Acceptance Testing.
• Conduct supply chain risk assessments, proactively identifying and mitigating potential disruptions to supply continuity.
• Maintain inventory management systems to ensure accurate tracking and traceability of all clinical materials.
• Monitor inventory levels at depots and clinical sites through the life of a trial and coordinate resupply efforts to prevent stockouts or overages.
• Ensure timely and compliant distribution of IMP to clinical trial sites globally, adhering to country-specific regulations and customs requirements.
• Ensure compliance with all regulatory guidelines (e.g., FDA, EMA, ICH) and Good Distribution Practices (GDP) across all clinical supply chain activities.
• Support regulatory inspections and audits by maintaining thorough documentation of supply chain activities.
• Collaborate with Quality Assurance to manage deviations, CAPAs, and continuous improvement initiatives.
• Lead and mentor one or more clinical supply chain professionals, providing direction, training, and development opportunities.
• Serve as a key point of contact with multiple functional areas and act as a liaison between internal departments and external partners to ensure alignment on clinical supply chain goals and timelines.
• Participate in cross-functional project teams to drive supply chain efficiencies and resolve challenges as they arise.

Associate Director, Clinical Supply Chain Management

Director

• Serve as a lead statistical programmer on one or more clinical studies
• Provide statistical programming oversight to programming vendors
• Review and validate datasets and TFLs programmed by vendors
• Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion
• Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate
• Participate in developing and implementing statistical programming processes and standards
• Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective
• Build and mentor a team of programmers to support clinical trials and pipelines
• Generate ad hoc analyses on ongoing basis

Associate Director, Statistical Programming

• MSL Leadership and Development - lead, coach and manage a team of MSLs
• Provide strategic direction, professional development, and performance management in a timely and consistent manner, regularly recognize strong performance and address performance gaps decisively
• Consistent field observations to provide MSL coaching and development and build relationships with key opinion leaders (KOLs) and investigators
• Regional execution of Medical Affairs strategy and objectives, ensure MSLs are equipped to engage with healthcare professionals (HCPs), KOLs, and other external stakeholders, delivering scientific and medical information that aligns with corporate strategy
• Regional oversight of MSL territory planning to achieve Medical Affairs objectives/goals
• Ensure MSLs have resources, tools and training to maximize field performance and enhance the support of KOLs and investigators
• Responsible for MSL team compliance, monitor and evaluate MSL activities, ensuring compliance with regulatory guidelines and internal policies
• Collaborate closely with cross-functional teams
• Provide scientific expertise and insights to help guide strategy and internal decision-making

Regional Director, Field Medical Affairs – East

Operations

• Partner with Scientific Communications, Medical Affairs, and cross-functional stakeholders to track and ensure timely delivery of congress activities across medical affairs.
• Proactively manage timelines and status trackers for medical congress activities and maintain accurate and up-to-date congress and publication plans.
• Manage and administrate standard systems for review and tracking of publications and medical materials, including routing and tracking review and running reports.
• Operational execution of congress activities, including booth scheduling, vendor coordination, metrics and asset tracking, badge procurement, and meeting registration.

Senior Manager, Scientific Communications – Planning & Operations

Business Operations

• Maintain and communicate a current overview of Clinical Operations Program status and issues.
• Work with Clinical Operations team members to identify resource constraints, risks, and conflicts that could impact the team’s ability to deliver according to plans.
• Provide Project Management support for 1 or more Clinical programs, including building and maintaining the clinical study plans by interfacing with our external partners
• Collaborate closely with the cross-functional Program Management team to ensure integration of Clinical Operations activities into overall program plans, monitor project deliverables and ensure tasks are on track.
• Work collaboratively to create project planning guidelines/playbooks for use across projects.
• Establish and track key performance indicators (KPIs) and metrics to evaluate performance and identify areas for improvement
• Document, standardize and publish department processes and procedures while seeking to identify potential operating efficiencies
• Prepare reports, presentations, and other deliverables related to project updates, process improvements, or other business initiatives
• Participate in Work Order and Change Order negotiation, review, and approval.
• Submit purchase orders in NetSuite, review and approve vendor revenue recognition, accruals, and invoices
• Assist with tracking outsourced activities as needed.

Manager, Clinical Business Operations

• Work closely with Commercial Leadership Team in the development of a comprehensive commercial strategy and pre-launch plan for the Company’s lead asset in moderate-to-severe Atopic Dermatitis
• Oversee and maintain the execution of the 5-year U.S. commercialization roadmap across Operations, Marketing, Market Access and Sales through cross functional commercial projects and initiatives that will define the go-to-market strategy
• Partner with Commercial Leadership in the evaluation, assessment and implementation of commercial operating model which includes commercial processes, systems and capabilities as well as the organizational design & structure to support commercialization
• Partner closely with Marketing & Market Access organizations to understand the needs and operational support required by each organization pre and post launch and lead efforts to incorporate those into go-to-market planning
• Serve as a member of cross functional program team workstreams across various portfolio development programs to ensure Commercial perspective is accounted for in the plans of Clinical Development, Medical Affairs, and Regulatory functions
• Establish a market and commercial competitive intelligence process to help the organization stay up to date on the latest market changes and competitive dynamics that will shape asset positioning and target product profiles (TPPs)

Senior Director, Commercial Strategy

Financial Planning and Analysis

• Enhance and maintain reports, models, and data integrations within Adaptive Planning (Adaptive Insights)
• Serve as a hands-on contributor supporting annual budgeting and forecasting cycles with Adaptive Planning, ensuring data accuracy, modeling consistency, and reporting logic
• Help enhance and standardize FP&A processes, reporting packages, and financial analysis as the company scales
• Support month-end reporting activities, including preparation of actuals, cost trend analysis, variance analysis, and business partner reporting for G&A functional areas
• Collaborate across G&A functional teams to compile budgets, forecasts, and long-range plans
• Act as liaison between business partners and Accounting, supporting monthly and quarterly accruals in accordance with GAAP and SOX requirements
• Support broader organization through ad hoc projects and financial analyses, as needed

Senior Financial Analyst, Financial Planning & Analysis

• Provide operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
• Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
• Ensure the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks
• Work closely with CROs to prepare and ensure proper development and execution of data management activities
• Review protocols to ensure database feasibility
• Provide effective oversight of all CRO data management related deliverables
• Ensure that eCRFs, database interfaces, programmed edit checks and external data files, CRF completion guidelines are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submissions
• Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed
• Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion.
• Responsible for documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is in an audit-ready state
• Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
• Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.)
• Ensure that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements

Associate Director, Data Management

• 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