Cristcot

Operations

• Coordinating commercial workflows, maintaining operational documentation, supporting communications and training logistics, and assisting with financial tracking activities
• Supporting the day-to-day execution of commercial initiatives, operational projects, and cross-functional activities to ensure efficient business operations
• Coordinating meetings, launch activities, workflows, timelines, and deliverables while providing administrative and operational support to the commercial team
• Schedule, coordinate and support execution of commercial initiatives, meetings, launch activities, and ongoing operational projects
• Assist with management of commercial workflows, calendars, timelines, and cross-functional deliverables
• Support training logistics, distribution lists, and commercial communications
• Maintain commercial documentation including contracts, vendor records, pricing files, presentations, and SOPs
• Draft, format, maintain, and update commercial SOPs, work instructions, templates, and operational documentation to support scalable business processes
• Ensure consistency, accuracy, and professional formatting across commercial presentations, reports, policies, and internal/external documents
• Track purchase orders, invoices, expense reports, and budget-related activities in partnership with Finance
• Strong technical writing and document formatting capabilities with attention to detail and consistency
• Ability to create clear, professional, and compliant operational documentation
• Develop and edit PowerPoint presentations for internal and external use

Commercial Operations Coordinator

Procurement

• Oversee and track company-wide spend across all functions, including Commercial, Clinical, R&D, Technical Operations, and G&A
• Partner with functional leaders to develop, manage, and forecast budgets
• Monitor actuals vs. plan, identify variances, and provide actionable insights
• Drive financial discipline and accountability across the organization
• Lead the financial review and tracking of all Statements of Work (SOWs) and vendor contracts
• Partner with Legal and functional teams to ensure SOWs are aligned with budgets and timelines
• Track spend against SOWs and proactively flag risks, overruns, or inefficiencies
• Support vendor selection and cost negotiations with data-driven insights
• Develop and maintain KPIs to track financial performance, vendor efficiency, and program-level spend
• Build dashboards and reporting tools to provide real-time visibility to leadership
• Deliver regular reporting packages to Finance leadership and executive team
• Analyze trends and recommend improvements to optimize resource allocation
• Act as a key finance partner to Commercial, Clinical Operations, Research, CMC, and Corporate functions
• Translate financial data into clear insights for non-finance stakeholders
• Support program teams in understanding financial implications of decisions
• Support quarterly and annual planning cycles, including budget setting and reforecasting
• Assist in long-range financial planning and scenario modeling
• Ensure alignment between operational plans and financial forecasts
• Implement and improve processes for tracking spend, SOWs, and financial performance
• Create and optimize use of financial systems, and dashboards
• Drive standardization and scalability as the company grows

Senior Manager, Procurement, Program Spend

Director

• Hire, develop, and lead a team of Territory Business Managers (TBMs), driving performance above target through structured coaching and development
• Coach team members on consultative selling, account management, and territory planning to meet or exceed goals
• Develop and execute a regional sales strategy aligned with national objectives, focusing on high-value opportunities and target accounts
• Monitor and drive performance metrics including TRx, NRx, market share, and HCP engagement using CRM and analytics tools
• Provide regional insights on payer dynamics, customer needs, and competitive landscape to inform broader commercial strategy
• Foster a culture of accountability, setting clear expectations and managing performance effectively
• Adapt regional strategies based on market changes including competition, access challenges, and payer dynamics
• Lead cross-functional collaboration with Marketing, Medical Affairs, Market Access, and Commercial Operations
• Support adoption of digital and AI-enabled tools to enhance field effectiveness and customer engagement
• Build and maintain strong relationships with key customers, accounts, and healthcare stakeholders
• Ensure compliance with all regulatory, legal, and company policies
• Manage regional budgets and allocate resources effectively to maximize return on investment

Regional Business Director, Multiple

• Support Cristcot in its growth by leading the manufacturing operations of drug-device combination products.
• Manage contract manufacturers (CMOs) to ensure reliable, compliant, and cost-effective production of device components and finished combination products.
• Oversee production schedules, equipment readiness, resource allocation, and line performance metrics.
• Ensure compliance with GMP, FDA, ISO, and company quality standards in all device-related operations.
• Work closely with Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams to support product development, validations, launches and commercial product supply.
• Support technology transfer of device and combination product processes from development to manufacturing.
• Ensure timely delivery of devices for clinical trials and commercial products.
• Lead relationships with external manufacturing partners, ensuring adherence to quality, delivery, and cost objectives.
• Monitor supplier performance and conduct regular business and technical reviews.
• Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for device assembly and packaging.
• Lead validation efforts (equipment, process, packaging, and cleaning), ensuring compliance with regulatory standards.
• Ensure accurate and complete documentation including batch records, deviation reports, CAPAs, and change controls.
• Support audits and inspections by regulatory authorities and partners.

Director, Device Manufacturing

• Lead the development and execution of the commercial operations strategy aligned with corporate and commercial objectives.
• Build and operationalize launch readiness plans to support the company’s first and future product launches.
• Partner with Commercial leadership to support annual brand planning, strategic planning, and long-range commercial forecasting.
• Ensure operational readiness across sales, marketing, market access, patient services, and analytics functions.
• Establish scalable infrastructure, processes, governance, and KPIs to support commercial growth.
• Design and optimize field force infrastructure including territory alignment, targeting, call planning, deployment strategy, and performance management.
• Lead incentive compensation design and administration while ensuring compliance and alignment with business objectives.
• Oversee CRM systems, commercial platforms, dashboards, and reporting tools to support field execution and customer engagement.
• Develop sales enablement capabilities and operational processes to maximize field effectiveness and customer experience.
• Build and lead commercial analytics capabilities including forecasting, market research, competitive intelligence, and performance reporting.
• Establish executive dashboards and reporting processes to support data-driven decision making.
• Oversee implementation and optimization of commercial systems and technologies, including CRM, data warehouses, analytics platforms, and digital engagement tools.
• Ensure strong data governance, operational efficiency, and business continuity across commercial systems and processes.
• Serve as a strategic partner to the Chief Commercial Officer and Commercial Leadership Team.

Vice President – Commercial Operations

• Lead the strategic planning, implementation, and management of all information technology systems and infrastructure.
• Interface with executives and SMEs across the organization.
• Work with outside vendors and partners to scope and implement platforms, technologies, and services.
• Develop and execute the company’s IT strategy aligned with business objectives and administrative priorities.
• Build, lead, and mentor a high-performing internal IT team.
• Develop strategy and identify use cases for standalone AI tools.
• Oversee day-to-day IT operations, ensuring reliable delivery of services across all business functions.
• Lead IT systems readiness for product launch.
• Ensure all systems meet regulatory requirements and maintain audit/inspection readiness.
• Oversee IT infrastructure and implement robust cybersecurity frameworks.
• Manage relationships with IT vendors and oversee outsourced partners.

Director, Information Technology

Manager

• Lead and manage the Quality department, including hiring, training, and performance management
• Ensure compliance with cGMP, FDA, EMA, ISO 13485 and other global regulatory requirements
• Oversee quality systems including CAPA, deviations, change control, and document management
• Function as the primary quality interface with CDMOs and testing labs.
• Drive inspection readiness and lead internal audits
• Review and approve batch records, SOPs, change controls, methods, specifications, protocols and reports, and quality-related documentation
• Collaborate with cross-functional teams to support product development and commercialization
• Manage supplier quality and oversee vendor qualification processes
• Identify and implement continuous improvement initiatives within the quality system
• Monitor key quality metrics and report trends to senior leadership
• Ensure proper investigation and resolution of quality issues and complaints

Senior Quality Manager

• Manage the lifecycle of controlled documents including SOPs, work instructions, policies, and templates.
• Administer and optimize the electronic document management system (eDMS) on an ongoing basis, as needed.
• Ensure proper version control, archival, retrieval, and distribution of documents
• Establish and maintain document control procedures aligned with GxP requirements
• Ensure all documentation complies with FDA, EMA, ISO 13485, and ICH guidelines (e.g., 21 CFR Part 11, 210, 211, 820)
• Support internal and external audits, inspections, and regulatory submissions
• Maintain audit-ready documentation and ensure inspection readiness at all times
• Partner with QA to enforce document control policies and best practices
• Develop and implement scalable document control processes to support company growth
• Identify gaps and drive continuous improvement initiatives
• Lead implementation or upgrades of document management systems
• Work closely with Quality, Regulatory, Clinical, CMC, Medical Device, Commercial, and Manufacturing teams
• Train employees on document control procedures and systems
• Serve as the subject matter expert (SME) for document control across the organization
• Hire, mentor, and manage document control staff as the organization grows
• Establish performance metrics and ensure high-quality output

Document Control Manager

Financial Planning and Analysis

• Generate financial reports and dashboards to analyze key performance indicators (KPIs) and financial metrics to provide insights into business performance
• Prepare comprehensive financial reports, highlighting key financial insights and trends
• Assist in the preparation of presentations and reports for executive leadership and board meetings
• Ensure the accuracy and integrity of financial data for reporting purposes
• Assist in the implementation of FP&A software tools
• Assist in the development, maintenance, and management of annual budgets, working closely with department leaders to establish financial goals and targets
• Prepare scenario planning for 3 statement financial models
• Contribute to the forecasting process by providing accurate and timely financial projections
• Conduct detailed expense and headcount variance analysis to assess budget versus actual performance
• Prepare presentations outlining and explaining reasonings for variances
• Monitor and analyze expenses, identifying opportunities for cost control and efficiency - improvements
• Support department leaders in managing budgets and achieving financial targets
• Own and update financial models and ROI analysis to support decision-making
• Assist in evaluating the financial impact of strategic initiatives and business strategies
• Own special projects and ad hoc analysis as directed by senior management
• Provide financial support for strategic initiatives and operational improvements

Senior Financial Analyst

Data Scientist

• Build the Data & Technology Ecosystem
• Design, develop and implement the company’s data architecture from the ground up (data ingestion, storage, transformation, and access layers)
• Evaluate and select appropriate tools and platforms (e.g., data warehouses, ETL pipelines, BI tools, CRM integrations)
• Establish scalable, compliant, and secure data infrastructure aligned with biotech/pharma regulations (HIPAA, GDPR where applicable)
• Define data governance frameworks, including data quality, stewardship, and access controls
• Identify, acquire, and integrate critical data sources to support commercial operations, including: Patient claims (medical & pharmacy), Prescription (Rx) data, Electronic health records (EHR), Provider-level data, Specialty pharmacy and hub services data, Payer and formulary data
• Translate commercial strategy into data requirements and analytics solutions
• Build datasets and data models tailored to key business questions (e.g., patient journey, targeting, segmentation)
• Develop and lead analytics to support: Launch planning and performance tracking, Sales force effectiveness and targeting, Patient identification and adherence patterns, Market access and payer strategy
• Create dashboards, KPIs, and reporting frameworks for executive and commercial stakeholders
• Apply advanced analytics (predictive modeling, segmentation, forecasting) to inform decision-making
• Act as a strategic partner to Commercial leadership to align analytics with brand objectives
• Collaborate with IT, Medical Affairs, Market Access, and Finance to ensure integrated data use
• Translate complex data insights into actionable business recommendations
• Manage external vendors (data providers, analytics partners, consultants)
• Operate both as a strategic leader and a hands-on contributor in a fast-paced environment

Director, Data Science – Commercial Analytics

Chief Marketing Officer

• Establish and direct the commercial vision, build the organization’s capabilities from the ground up, and ensure most effective launch readiness and execution.
• Develop, refine, and own Cristcot’s commercial launch strategy, ensuring alignment with clinical, regulatory, and corporate timelines.
• Build launch frameworks including positioning, branding, pricing, market access, sales deployment, and patient support programs.
• Lead cross-functional launch excellence initiatives and establish KPIs to measure launch performance.
• Oversee the build and scale of the commercial organization, developing core commercial capabilities—from forecasting and demand planning to data infrastructure and field force operations.
• Mentor and guide the divisional Vice Presidents and ensure the commercial division has the structure, resources, and strategic guidance needed for success.
• Establish the commercial vision for Cristcot’s current and future products, with a focus on disciplined execution and rapid market uptake.
• Work closely with R&D, Regulatory, Medical, Operations and Finance to ensure commercial insights inform critical decisions, lifecycle management, and portfolio planning.
• Lead commercial due diligence for strategic partnerships, co-promotion opportunities, or expansion into new therapeutic or geographic areas.
• Oversee payer strategy, pricing, contracting, and reimbursement to ensure optimal early access and adoption.
• Build relationships with key opinion leaders, healthcare systems, specialty pharmacies, distribution partners, and advocacy groups.
• Represent the Commercial Division to the Board, investors, and external stakeholders as needed.
• Manage and optimize the commercial budget, ensuring efficient resource allocation in a launch-stage environment.
• Drive revenue performance and growth goals across all products.
• Ensure commercial operations have the tools, analytics, and insights needed to guide decision-making.
• Foster a culture of agility, accountability, collaboration, and innovation consistent with Cristcot’s entrepreneurial environment.
• Build a diverse, high-performing team capable of executing at both strategic and tactical levels.
• Champion Cristcot’s mission and values internally and externally.

President / Chief Commercial Officer, Hydrocortisone Acetate Division

Artificial Intelligence

• Support Cristcot in identifying opportunities to automate business processes across all functions including Regulatory, Clinical, Commercial, Operations, and Administration.
• Collaborate closely with all functions within Cristcot and engage with external technology vendors and Managed Service Provider.
• Move the organization from 'AI curious' to 'AI native' by operationalizing ChatGPT Enterprise and building specialized, high-impact workflows.
• Develop and lead workshops for scientists and executives on advanced prompt engineering and the effective use of ChatGPT Enterprise.
• Build and maintain end-to-end automations using tools like LangChain, LlamaIndex, or Microsoft Power Automate.
• Automate the sifting of scientific literature for new targets and assist in drafting reports or clinical trial documentation.
• Ensure all AI solutions comply with HIPAA, GDPR, and data privacy standards by implementing robust security and controls.

AI Solutions – Digital Transformation Specialist, 3-6 Month Contract

Clinical Operations

• Support the Sponsor-side research team in clinical research activities including Phase 2 and Phase 3 studies
• Manage third-party vendors and internal study teams
• Oversee adherence to the Company’s Quality Management System (QMS)
• Track study schedules, deliverables, and execution monitoring
• Document and organize studies in compliance with regulations and SOPs
• Communicate with Senior Clinical Team about objectives, timelines, and deliverables
• Organize study operations documents and facilitate QA/QC checks.
• Support study start-up through closeout

Director, Clinical Operations – Sponsor Side

Executive Assistant

• Managing complex calendars, scheduling meetings, and ensuring priorities are maintained, conflicts are resolved, and follow-ups are completed across teams.
• Coordinating domestic and international travel arrangements for executives, including managing last-minute changes and handling urgent issues independently, ensuring alignment with business priorities.
• Preparing and editing correspondence, presentations, meeting agendas, and reports, ensuring accuracy and alignment with Cristcot’s brand and strategic objectives.
• Serving as a liaison between executives and internal/external stakeholders, prioritizing inquiries, and fostering effective communication and relationship management.
• Organizing and supporting high-impact meetings and launch-related events, with meticulous attention to detail.
• Maintaining a focus on continuous improvement by juggling multiple tasks, demands, and scenarios, listening carefully, assessing objectively, and evaluating quickly and accurately.
• Fostering and championing a company culture that encourages a positive work environment and teamwork.
• Handling confidential information with discretion and maintaining organized records to support decision-making and compliance.

Project Manager

• Lead product launch readiness and corporate strategic initiatives by overseeing cross-functional timelines, managing risks and dependencies, tracking KPIs, facilitating decision-making, and driving post-launch reviews to ensure successful execution and continuous improvement.
• Oversee launch plan timelines across the enterprise, focusing on critical path tactics and detailed functional deliverables.
• Actively track progress, risks, and dependencies, proactively identifying and resolving blockers to keep initiatives moving forward.
• Monitor and report on Key Performance Indicators (KPIs) for launch readiness and post-launch performance.
• Facilitate efficient meetings that drive decisions, clarity, and accountability through meeting materials and engagements with stakeholders.
• Coordinate launch readiness reviews and go/no-go decision gates across functions.
• Manage dependencies and ensure alignment of training, collateral, and operational deliverables.
• Lead post-launch reviews to capture lessons learned and drive continuous improvement.
• Develop and maintain comprehensive project plans for corporate strategic initiatives as assigned.
• Coordinate cross-functional teams to align objectives, deliverables, dependencies, and milestones.
• Proactively manage risks, issues, and cross-project dependencies across multiple projects at once.
• Communicate project status, risks, and decisions clearly to leadership and key stakeholders.
• Support change management and adoption of new tools, processes, and scalable ways of working.