BlueRock Therapeutics

Manager

• Own the relationship with assigned ExP(s) and act as key point of contact for BlueRock.
• Responsible for overall ExP performance and project execution including budget and timeline adherence.
• Responsible for leading and actioning issue resolution to a mutually beneficial outcome.
• Own annual forecasting, planning, and resource allocation with ExPs in collaboration with BlueRock functional groups.
• Lead cross-functional operational meetings with assigned ExP(s) to drive improvements in ExP collaboration, quality, and performance.
• Act as escalation contact for performance remediation.
• Negotiate and manage ExP related contracts (MSA, SOWs, QAAs).
• Own risk management and continuous improvement activities within ExP network in collaboration with BlueRock QA and operational teams.
• Work closely with BlueRock workstream leads to identify ExP-specific constraints and negotiate resource allocation with ExPs to reduce risk.
• Own marketplace evaluation efforts (RFI, RFP) to ensure BlueRock’s ExP network is either aligned or leading industry standards for performance and efficiency.
• Maintain strong network awareness in all 3 categories (analytical QC, contract manufacturing, device development) to enable pivots when necessary and build network robustness.
• Process purchase requisitions, review open purchase orders, and follow up on status of placed orders as required.
• Support the Annual Budget process for all categories by aligning functional needs with ExP pricing and timing.

Senior Manager, External Manufacturing – Development Services

Medical Director

• Serve as the medical safety lead and subject matter expert across BlueRock’s clinical trial portfolio, providing hands-on safety review and medical oversight of all ongoing studies
• Lead SAE/SUSAR medical assessment, causality determinations, and benefit-risk evaluation in close partnership with Clinical Development and Regulatory Affairs
• Own safety signal detection and management, including aggregate safety review and signal tracking across programs
• Drive preparation and medical review of safety sections for protocols, statistical analysis plans, clinical study reports, IND/CTA submissions, and periodic aggregate reports (DSURs, PBRERs)
• Develop and maintain BlueRock’s Core Safety Information and reference safety information
• Oversee safety vendor selection, management, and deliverable quality for PV operations
• Ensure global safety reporting compliance and maintain inspection readiness
• Contribute to the evolution and growth of BlueRock’s Safety and PV organization as the pipeline expands
• Collaborate with our parent company Bayer and be the point of contact for the Safety/Pharmacovigilance team within Bayer
• Oversee safety operations and safety scientists on the BlueRock team

Senior Medical Director, Clinical Safety

Director

• Lead data management efforts to coordinate study from start-up activities, interim data cuts to support various activities, to close out activities
• Represent data management function at cross-functional meetings
• Lead regular data review meetings in a cross-functional team environment.
• Responsible for data cleaning, query and resolutions, review of medical coding
• Oversee or responsible for external lab data reconciliation, manage and reconcile external data, authoring data transfer agreements
• Lead or oversee database lock activities and ultimate archiving of study data
• Supervise and mentor supporting data managers to ensure data management activities are conducted as expected
• Lead eCRF development and facilitate cross-functional reviews of specification
• Oversee and direct database building activities, including review of edit check specifications, lead and perform the user acceptance testing
• Monitor data collection, data cuts, coding, and cleaning by CROs through tracking of study metrics and targeted data reviews
• Review data management plans, CRF completion guidelines, external data transfer specifications and other study documentation, ensuring all data management documents are completed and to be filed in the study eTMF and are ready for regulatory inspection
• Using data visualization tools to perform data review or quality check data with cross function teams
• Review clinical study protocols and statistical analysis plans
• Participates in other activities and meetings to support Data Management/Biometrics as necessary
• Support in the SOP’s, working instruction, templates development for data management head of the Data Management

Associate Director, Data Management

Translator

• Develop translational strategies designed to support clinical development plans, the regulatory path, and product commercialization.
• Lead the development and implementation of translational imaging strategies in support of clinical proof-of-mechanism, patient stratification, dose selection.
• Serve as the neuroimaging lead on cross-functional program teams.
• Partner with Research to discover and characterize novel imaging biomarkers in preclinical studies.
• Develop imaging methods and analytically validate imaging tools for clinical use.
• Implement clinical biomarkers and ensure biomarker-driven decision-making across all phases of drug development.
• Lead cross-functional imaging governance (e.g., Imaging Steering Committee) advancing the use of imaging biomarkers to enable demonstration of disease-modifying effects.
• Deliver subject matter expertise with respect to clinically advanced techniques in MRI, PET, SPECT, HRCT and other modalities as needed.
• Oversee CRO vendor/partners ensuring that they optimally execute clinical and preclinical imaging projects in the US, Canada, and other regions of interest.
• Provide support for the Business Development organizations as needed on diligence efforts.

Director, Translational Medicine, Imaging

Data Engineer

• Participating in developing and implementing an overall organizational data strategy. The strategy includes data architecture, data management standards, implementation and management of data warehouses, and data analytics systems.
• Creating data architecture within the organization, applying architectural principles to ensure the IT solutions are secure, reliable, scalable, and sustainable, and developing a cohesive technical vision with IT standards.
• Collaborating closely with IT Infrastructure, Bioinformatics, and BlueRock functional groups to ensure business needs are actively being aligned with our solution, and both business and technical requirements are understood and documented by all stakeholders.
• Architecting, creating, managing, and optimizing data pipelines, designing compute workflows and storage solutions for a variety of data assets, and developing integrated data solutions to drive success in analytics workflows.
• Designing and implementing comprehensive solutions for transferring, storing, delivering, and optimizing R&D, TechOps, and MFG data, and associated data specification, documentation, SOP, WIs etc., using public cloud technology (AWS). Design, implement, and maintain data pipelines, ETL workflows, analytical solutions, and respective cloud and computing environments; or implement and configure third-party solutions.
• Working closely with IT teams and vendors to design, implement, and/or improve data integration capabilities that are scalable and maintainable and deliver optimal value based on agreed-upon requirements.
• Implementing and owning data integration across our application stack that keeps data fresh and FAIR.
• Creating reference diagrams, charts, and documentation for the architecture.
• Ensuring quality, availability, and integrity of code, solutions, and respective systems and integrating proactive strategies and best practices regarding data integrity, security, scalability.
• Actively identifying new technologies and practices in the domain through internal and external network. Telecommuting permitted.

Senior Data Architect

Clinical Operations

• Serve as business lead for one or more systems owned by Clinical Operations. Provide business support for multiple systems and applications used by Clinical operations.
• Work closely with the business owner/lead, IT systems owner/team, and relevant vendor partners. Contribute to or lead vendor management, where appropriate, dependent on owning department for vendor relationship.
• Work closely with business stakeholders inside and outside of Clinical Operations, where applicable, to understand current processes, needs, gaps, and value potential. Draft business requirements that are clear and actionable by IT/vendor partners.
• Oversee business requirements to successful implementation, including communication to IT/vendor partners and business stakeholders, perform business testing, develop processes/trainings, and where needed, refine requirements.
• Oversee use and accuracy post go-live by monitoring data/metrics, hosting office hours, and managing user inquiries (mailbox). Utilize a proactive approach to assessing accuracy, troubleshooting, and seeking user feedback.
• Maintain a repository of standard terms, definitions, and calculations utilized in respective systems (the “lexicon”). Collaborate with stakeholders on business needs, create a common understanding, and build alignment across systems.
• Serve as a system Subject Matter Expert (SME) and provide support to users and teams on various use cases. This could include providing initial training or guidance ahead of an activity; providing routine support throughout an activity; assisting in vendor management for a subset of data-focused activities or of a vendor-owned system; or, where appropriate, leading the business team on a particular activity e.g., a one-time deep-dive analysis.
• Support department-level system, data or process needs for Clinical Operations. This will include, but not limited to, management of the department SharePoint page and support on the clinical trials mailbox.
• Support Core Capabilities and broader Clinical Operations team members on system and data-related needs. This could include SME support for a particular system, compilation of information, or broader input from the system/data/process perspective based on expertise.
• Support/manage process improvement efforts, ensuring adherence to BRT standards, and all applicable regulations and guidelines.
• Review/develop business terms, BRT Working Practices, Standard Operating Procedures (SOPs), templates, training, platforms and systems to drive improvements that are advantageous to BRT.
• Represent values-based leadership consistent with BRT Core Values: courage, urgency, integrity and community.

Senior Manager, Systems and Metrics – Clinical Operations

• Provides strategic and operational leadership for one or more complex clinical studies, ensuring successful delivery through the study lifecycle (planning to execution) ensuring adherence to timelines, budgets, and quality standards.
• Develops executable study plans and milestones. Establishes and maintains clinical study timelines.
• Utilizes operational data and metrics to drive high-quality planning processes and operational execution. Monitors the same to drive overall performance and risk management.
• Maintains a comprehensive overview of study status, proactively communicating progress, risks, and mitigation strategies to stakeholders.
• Leads/partners in the development and/or QC review of key study documentation (e.g, study protocols, informed consents, monitoring plans, operational manuals)
• Drives operational initiatives key to successful study execution including but not limited to site identification/qualification, site activation strategy, site performance management, overall enrollment success (including mitigation/rescue actions as needed).
• Ensures clinical activities are conducted in accordance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines and internal quality standards.
• Supports or leads aspects of audit and inspection readiness and risk mitigation initiatives, including root cause analysis and CAPA development/closure for operational findings on assigned studies.
• Actively contributes to the advancement of department and organizational initiatives and processes.
• Leads study and/or project team(s), including effectively partnering with colleagues from other disciplines. (Clinical Development, Regulatory, Data Management, Safety, Quality) and external partners (CROs, vendors, academic collaborators, alliance partners) to ensure seamless trial execution.
• Participate in the mentorship of clinical operations staff.
• Contributes to the development and implementation of novel clinical operations activities and methods in cell therapy.