BlueRock Therapeutics

Compliance

• Providing regulatory leadership and guidance to CMC teams developing cell and gene therapy products
• Oversight and generation of quality dossiers to support Health Authority meetings, clinical trial applications and market applications in the U.S. and multiple international territories
• Working closely with technical CMC teams in USA and Canada, project teams
• Serving as point for interactions with global health authorities to achieve alignment on regulatory strategies
• Independently managing and prioritizing multiple complex projects
• Driving workflows related to Health Agency interactions (ie, briefing documents and responses to questions)
• Interfacing with the Health Authorities for CMC submissions and CMC-related issues
• Identifying regulatory opportunities and risks
• Anticipating and communicating possible regulatory paradigm shifts
• Reviewing and providing regulatory assessments on change controls
• Preparing and managing CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness
• Managing relationships with diverse teams in a collaborative manner
• Supporting departmental initiatives, including special projects, budgeting, and authoring departmental documents

Associate Director, Regulatory Affairs – CMC

Clinical Operations

• Provide strategic and operational leadership for one or more complex clinical programs, ensuring successful execution from early-phase through pivotal trials
• Develop and maintain clinical program planning and execution timelines. Model a data driven mindset to planning and oversight of studies.
• Maintain a comprehensive overview of program status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
• Drive operational planning, including feasibility assessments, country/site selection, and resource allocation.
• Oversee all aspects of clinical trial management, including protocol development, study start-up, enrollment, monitoring, data collection, and close-out.
• Ensure adherence to timelines, budgets, and quality standards across all studies within the program.
• Collaborate with internal teams (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators) to ensure seamless trial execution.
• Implement and track key performance indicators (KPIs) and operational dashboards to monitor program health.
• Lead the selection, qualification, and management of CROs and vendors, ensuring high-quality deliverables and contract compliance.
• Serve as the primary point of escalation for operational issues at the program level.
• Build and maintain strong relationships with clinical trial sites, investigators, and key opinion leaders.
• Ensure all clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines.
• Support audit readiness and lead risk mitigation initiatives.
• Contribute to the advancement of department and organizational initiatives.
• Provide line management, coaching, and mentorship to clinical operations staff.
• Foster a culture of accountability, innovation, and professional growth.
• Champion the development and implementation of novel clinical operations activities and methods in cell therapy.

Senior Director – Clinical Operations Program Leader, Ophthalmology

Manager

• Own CSI hub scheduling and forecast alignment based on trial enrollment and treatment center surgical capacity
• Lead the monthly rolling forecast process with Clinical Operations, including demand/supply reconciliation, assumptions, constraints, and action planning
• Partner with Clinical Ops to translate enrollment updates, protocol changes, and planning scenarios into hub plans and supply readiness actions
• Serve as PM and lead facilitator for the Clinical Supply Integrated Planning (CSIP) forum, including agenda setting, pre-reads, decision capture, action tracking, and risk escalation
• Lead cross-functional planning standups across Supply Chain to ensure readiness, alignment on constraints, and clear inter-functional commitments
• Represent Tech Ops / Clinical Supply as the primary planning interface in Clinical Operations meetings and program forums
• Build, maintain, and improve integrated planning dashboards, KPIs, and leadership reporting
• Lead scenario planning and tradeoff analysis, and provide recommendations to support leadership decision-making
• Consolidate clinical and non-clinical CSI hub demand, including engineering runs, tech transfer, and training activities, into one integrated planning view
• Standardize and continuously improve integrated planning processes, governance, and documentation, while supporting scalable operating models and providing backup coverage for critical logistics operations as needed

Manager, Clinical Supply

Financial Planning and Analysis

• Serve as a finance advisor to Executive Leadership, shaping BlueRock’s capital allocation and portfolio strategy through data-driven insights.
• Define and articulate the enterprise financial narrative, connecting corporate strategy, operational milestones, long-range plans, and external messaging.
• Act as a key thought partner to the Chief of Staff and senior program and functional leadership to ensure financial plans clearly reflect strategic priorities and trade-offs.
• Lead comprehensive scenario modeling and strategic initiative evaluations that guide investment decisions and risk-return assessments.
• Establish frameworks for financial decision-making that embed strategic discipline across the company.
• Lead the end-to-end annual SBP and long-range planning cycles, from strategic design through execution and communication.
• Oversee an agile forecasting model that identifies and manages value drivers, risks, and opportunities in real time.
• Ensure financial rigor and accountability by building strong partnerships with R&D, Program Management, and operational functions.
• Develop and deliver executive-level management reporting that supports timely and informed decision-making.
• Support the Bemdaneprocel Product Team (Bemda PT) as the key Finance lead to support decision making and go/no go decisions.
• Prepare and present high-quality financial materials for Executive Committee, including strategic deep dives.
• Provide clear, concise financial perspectives to support Board discussions on strategy, capital deployment, and long-term value creation.

Senior Director, Financial Planning and Analysis

Director

• Lead company-wise data management strategy and operating model, positioning data as a strategic asset and enabling high-quality, trusted, and usable data across the end-to-end data continuum.
• Build data management capability, including governance, data quality, metadata/lineage, stewardship, and standards adoption.
• Partner with internal and external collaborators (business, IT, analytics/product teams, clinical operations/strategy, and vendors) to align priorities and deliver interoperable data solutions.
• Translate strategy into actionable roadmaps with milestones, KPIs, and clear ownership; monitor performance and service levels to ensure timely, high-quality delivery.
• Lead, mentor, develop high-performing teams and build strong relationships with business partner/vendors; conduct vendor qualifications and manage partner performance to meet quality and timeline expectations.
• Oversee standards governance and lifecycle management, including evaluation of enhancements, managing deviations, and driving continuous improvement through automation and process optimization.
• Ensure compliance with applicable regulatory expectations and internal SOPs; support inspection readiness and respond to regulator questions related to data and standards.
• Represent the organization in relevant industry standards forums and professional groups; communicate evolving guidance, standards, and best practices to internal stakeholders.

Senior Director, Data Management

Business Operations

• Utilize business process modeling to analyze existing business operations and supply chain processes and identify areas for workflow efficiencies and automation.
• Collaborate with cross-functional teams to understand project, goals and KPI tracking workflows and reporting systems.
• Support the design and development of a resource planning tool, forecasting and tracking FTE allocations.
• Work closely with project managers and stakeholders to gather requirements and ensure alignment with business objectives.
• Develop comprehensive documentation and visual representations outlining current processes, proposed process improvements and workflow optimizations.
• Visual models may be in the form of flowcharts, diagrams, or other formats that illustrate the sequence of activities, decision points, and flow of information.
• Create reports and dashboards in PowerBI and Smartsheet. Support data modeling enhancements.
• Develop and implement automations leveraging Microsoft applications (i.e. PowerAutomate, PowerApps, Copilot Studio, SharePoint and Excel) as well as Smartsheet.
• Assist in the implementation and testing of new processes, tools and application of AI.
• Generate regular reports and presentations to communicate progress and findings to the leadership team.

Business Operations Analyst

Accounting Manager

• Assist with the preparation and analysis of General Ledger accounting and accounts payable reports
• Support month-end close by performing account analysis, reconciliations and documentation of supporting schedules with timely follow up
• Process and review company expenses in Concur for multiple legal entities and ensure complete and correct GL coding in a timely manner
• Provide adhoc reporting and analysis as needed
• Assist with building, maintaining and documentation of a strong internal control environment
• Assist with documenting and building presentations for finance processes

Accounting Intern

Data Engineer

• Contribute to the development, testing, and refinement of the cell bank knowledge base, including user‑facing query features and human‑in‑the‑loop data validation.
• Support data workflows connected to the Electronic Lab Notebook (ELN), enabling efficient data ingestion and retrieval for downstream analysis.
• Assist with foundational AWS data engineering tasks such as dataset preparation, pipeline setup, and cloud‑based storage maintenance.
• Apply emerging data engineering and analytical skills to real projects, gaining hands‑on experience with industry‑standard tools, platforms, and practices.

Co-Op, Data Engineering

• Support the development, maintenance, and improvement of financial models/systems used for forecasting, budgeting, and long-range planning.
• Assist in preparing monthly and quarterly reporting packages, including variance analysis and performance decks for leadership review.
• Analyze financial and operational data to identify trends, risks, and opportunities.
• Contribute to the preparation of materials for senior leadership, including presentations for budget and board reviews.
• Partner with accounting during month-end to ensure accuracy of accruals and overall results.
• Support ad-hoc analysis and requests from business partners.

Intern, Financial Planning & Analytics

Medical Director

• Provide expert scientific and medical support and leadership to both preclinical and clinical stage BlueRock programs
• Support development and progression of a robust BlueRock neurology pipeline
• Medical monitoring and clinical review of active programs and studies
• Establish strong relationships with thought leaders in the field
• Represent the company in the neurology space both internally at meetings and externally, including global conferences.
• Support the neurology pipeline by contributing to the assessment of potential new products or programs
• Work with cross-functional teams, and contribute to strong, collaborative efforts to strengthen internal capabilities
• Lead, contribute to, and provide oversight to development of clinical documents
• Contribute to the analysis, interpretation and reporting of preclinical and clinical data
• Provide clinical and scientific content and detailed review for regulatory documents, and contribute to the overall strategy in regulatory submissions and interactions
• Provide strategic programmatic input through interaction with the development leadership team
• Provide mentorship and support to more junior team members

Associate Medical Director, Neurology

Medical Director, Neurology

Operations

• Support Program Toxicologists in the design of nonclinical studies
• Lead Nonclinical Study Team(s) for multiple studies and assets
• Lead nonclinical study start-up, execution, and timely reporting of results and ensure organizational awareness around study progress
• Partner with CRO to plan and manage study timelines
• Act as the internal lead to ensure smooth transfer of study materials to CRO in support of study plans
• Partner with Research, CMC, Device, and other cross-functional teams to ensure awareness around study timelines, upcoming milestones, and study reporting
• Manage all associated tasks in the planning, initiation, monitoring, and compliance of nonclinical studies
• Develop a relationship with key leaders at CRO, including Study Directors and Business Development
• Travel regularly to CRO to oversee study execution
• Travel to audit CROs/labs as needed
• Ensure raw data and study reports are archived appropriately
• Ensure clinical and nonclinical samples are archived appropriately
• Collaborate within TMND to ensure broad awareness around nonclinical strategy and input into forward looking plans

Associate Director, Toxicology Operations

Content Writer

• Provide strategic and operational leadership for all Medical Writing activities to support BlueRock’s portfolio, from early development through product registration.
• Establish and oversee a cohesive, scalable Medical Writing function that delivers high-quality regulatory documents that are aligned with BlueRock’s global strategy, development timelines, and corporate priorities.
• Develop and lead an internal medical writing team, oversee vendor partnerships.
• Serve as a key strategic partner to Regulatory Affairs, Pharmacovigilance, Clinical Development, Clinical Operations, Biometrics, Translational Science, and Technical Operations.
• Help shape future-state capabilities, including AI-enabled medical writing, platform-based content reuse, and collaboration models with Bayer colleagues.