BlueRock Therapeutics

Compliance

• Develop overall regulatory strategy for assigned programs, working closely with the nonclinical and clinical teams, in conjunction with the Regulatory CMC and Device leads
• Provide regulatory leadership as the Global Regulatory Lead to program teams and subteams as the go to point of contact for regulatory strategy on assigned program(s)
• Lead the Regulatory Strategy Subteam(s) in the development of global regulatory plans to support assigned program(s)
• Collaboratively identify regulatory risks to product development and design risk mitigation strategies as aligned with cross-functional SMEs
• Provide regulatory support and contribute to the development and implementation of regulatory strategies to support the approval and commercialization of assigned products in compliance with applicable Health Authority requirements, including the identification of gaps or risks and opportunities to expedite development through innovative pathways
• Collaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout the product lifecycle and to prepare regulatory submissions (eg, meeting requests, briefing documents, IND/CTA filings, marketing applications, designation requests, etc…)
• Lead content development, organization, and coordination of cross functional regulatory submissions (e.g., INDs, CTAs, BLA, etc…)
• Author, coordinate, review, and execute submissions and responses to regulatory authorities related to INDs, CTAs, amendments, Information Requests, within appropriate timelines and in accordance with regulations and guidelines.
• Maintain detailed knowledge of the evolving global regulatory landscape relevant for advanced therapies including accelerated review programs. Assess the impact of new regulations/guidance on internal programs and communicate relevant changes to internal stakeholders
• Contribute to regulatory department initiatives to develop procedures and working practices

Director, Regulatory Affairs Strategy

Vice President

• Provide strategic and operational leadership for BlueRock’s neurology pipeline, including bemdaneprocel (DA01), DA02, MG0X, and future programs targeting Parkinson’s disease and other neurodegenerative disorders.
• Serve as the primary clinical expert and thought leader internally and externally for neurology clinical development.
• Design and oversee execution of clinical studies, including protocol development, study reports, and regulatory submissions (IND, BLA).
• Lead the translation of preclinical findings into clinical strategy and execution.
• Build, inspire, and lead high-performing, cross-functional teams (research, regulatory, CMC, clinical operations, IP, etc.) in a dynamic, matrixed environment.
• Foster a culture of innovation, collaboration, and scientific excellence.
• Establish and maintain relationships with leading academic collaborators, investigators, and thought leaders in neurology, cell and gene therapy, and translational medicine.
• Lead clinical content and contribute to overall strategy for regulatory interactions and submissions, ensuring alignment with global standards and regulatory authorities (FDA, EMA, PMDA, etc.).
• Mentor and develop Medical Directors and Clinical Development Scientists, fostering innovation, teamwork, and excellence.
• Provide clinical perspective to overall business strategy, integrating commercial, competitive, and scientific viewpoints.
• Champion the development and implementation of novel clinical trial designs and methods in neurology and cell therapy.

Vice President, Clinical Development – Neurology

Manager

• Prepare, review, and negotiate a variety of contracts including CTAs, MCTAs, CDAs, and consulting agreements in compliance with company policies and industry standards.
• Oversee the end-to-end regional/global site contracting process—from intake and drafting through execution and renewal—ensuring timely delivery and alignment with project and business objectives, with a focus on implementing effective and sustainable processes, templates, and tools.
• Accountable as the primary BlueRock communication conduit for all site contracting matters.
• Identify contractual risks and provide guidance to stakeholders to mitigate exposure while supporting company goals.
• Work closely with Legal, Clinical Operations, Procurement, Finance, and R & D to ensure contracts reflect appropriate business and risk positions.
• Create and maintain investigational grants financial benchmarks for assigned clinical trials.
• Drive alignment for financial negotiation parameters and manage financial escalations when applicable to ensure compliance adherence.
• Work closely with Finance and Operations stakeholders to establish study/project forecasts and manage relevant financial tracking and accruals/review invoices.
• Ensure adherence to time-based site payment disbursement goals.
• Support Purchase Order generation and management.
• Support/manage process improvement efforts, including but not limited to ensure 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.

Manager, Clinical Site Contracts

Director

• Serve as the PV lead for assigned programs, accountable for end-to-end safety deliverables including signal detection, aggregate reporting, and risk management planning.
• Represent PV on program-level governance committees and cross-functional teams, ensuring clear role delineation between PV and Clinical Development.
• Lead the preparation and PV input into protocols, Investigator Brochures, ICFs, SAPs, CSRs, regulatory submissions, and labeling documents for assigned programs.
• Develop and maintain program-level PV strategies aligned with global regulatory requirements and company objectives.
• Lead PV contributions to regulatory authority interactions and inspection readiness activities for assigned programs.
• Partner with CROs and vendors to ensure timely and compliant PV deliverables; monitor performance and escalate issues as needed.
• Contribute to departmental process improvement and knowledge-sharing initiatives.
• Mentor junior staff or consultants supporting PV deliverables.

Director, Pharmacovigilance Scientist

Translator

• The Associate Director of Bioanalysis, Translational Medicine and Nonclinical Development, will be expected to take on a highly visible role with internal and external stakeholders through the management of clinical and preclinical biomarker analysis for BlueRock’s development programs.
• The Associate Director will leverage their bioanalytical biomarker expertise to advance the company’s pipeline. As part of the Translational Medicine and Nonclinical Development team, this role provides unique opportunity to impact the development of novel cell therapies in multiple therapeutic areas including neurology and ophthalmology.

Associate Director – Bioanalytical Sciences, Translational Medicine, Nonclinical Development

Operations

• Lead, contribute to, and track activities on product-specific and above-brand programs to ensure strategic focus and timely execution of deliverables, including coordination of internal and external timelines and deliverables and leadership of team efforts.
• Provide operational efficiencies by implementing process improvements, providing guidance and support to team members, quickly identifying resolutions to issues, and developing communication plans to engage key stakeholders.
• Optimize achievement of overarching program strategy by identifying process improvements, instituting best practices, supporting development of tools, templates and reports, and implementing feedback from team members.
• Manage the medical affairs SharePoint and Team site and project tracking tools to maximize communication updates and ensure content maintenance.
• Support medical conference planning and execution including compliance submissions, booth registrations/logistics, medical materials delivery, and pre/post meeting activity tracking and reports.
• Oversee medical education grant proposals from intake through compliance submission and contracting.
• Project manage specific medical plan deliverables, including coordinating strategy/scope development, logistics and vendor management, and coordinating logistics and content development for events and trainings.
• Provide contract support with external vendors including defining project scope, negotiation, and execution.
• Lead planning and execution of ad hoc projects ensuring alignment with corporate objectives and executive leadership support.
• Lead metrics tracking and reporting, contracts, software implementation, and product launch/integration related activities.
• Deliver advisory board support from venue logistics through compliance documentation and HCP contracting/payment.
• Contribute to RWE programs including planning, contracting, technical execution, and study reports (abstracts, posters, manuscripts).
• Contribute to development of processes and tools that continuously improve resource utilization and quality of clinical study activities and deliverables.
• Contribute to general operational MA activities including budget management, vendor oversight, external meeting coordination, Medical Information and Pharmacovigilance operational activities.

Associate Director, Medical Affairs Operations

Communications

• Lead the creation and execution of the global medical communication strategy across BRTx pipeline development programs in neurology and ophthalmology.
• Develop high-quality, scientifically accurate medical content including slide decks, FAQs, publications, abstracts, posters, and manuscripts
• Partner with Clinical Development, Early commercialization, Regulatory, Program Management, and Corporate Development to ensure consistency and alignment across all external communications
• Lead the development and management of Scientific Communication Platforms (SCPs) and Lexicon/Glossary documents for bemdaneprocel and OPCT-001
• Lead strategic publication planning and execution in alignment with GPP and ICMJE guidelines, corporate goals and goals of the Medical Affairs team
• Support advisory boards
• Lead strategic planning and execution of medical and scientific congresses, including abstract submissions, symposia, medical booth activities and KOL engagement
• Support the development and maintenance of a dynamic KOL profiling strategy to identify, segment, and prioritize key external experts
• Collaborate with internal stakeholders to develop training materials for field medical and commercial teams
• Ensure all content is compliant with regulatory requirements and company standards
• Manage external vendors and medical writers as needed
• Report directly to the Vice President of Medical affairs.

Director, Medical Communications

• Manage asset life cycles for GMP manufacturing equipment, utilities, facility and HVAC.
• Provide the necessary technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment; collect, analyze and report equipment downtime information; ensure resolution of critical equipment items. Perform Risk Assessments and resolution of risk analysis.
• Understand and maintain the CMMS, EMS & BMS. Develop and monitor alarms as appropriate.
• Resolve Quality action items and write Engineering Assessments as Subject Matter Expert (SME).
• Coordinate maintenance activities and shutdown requirements for production equipment and facilities.
• Develop, review and implement recommendations to improve reliability of infrastructure and production systems. Maintain the Calibration, Maintenance and Safety procedures in defined area of responsibility.
• Direct and supervise the BlueRock facilities team. Manage employees, contractors and consultants as required to maintain safe and operational facilities.
• Engineering lead in support for audits conducted by internal and external agencies.
• Support a proactive EHS culture by ensuring timely closure of EHS actions and maintaining alignment with regulatory and internal standards.
• Partner with EHS to create Job Safety Analysis workflow for non-routine work and for contractor management strategies to identify and mitigate hazards.
• Schedule and execute maintenance activities including plant shutdowns; plan/execution of both OPEX & CAPEX projects and supporting technology transfer.
• Serve as technical system owner of BlueRock’s Computerized Maintenance Management System (CMMS), Environmental Monitor Solution and Building Management System; maintain GMP compliance, execute remediation, perform routine system data reviews, alarm response & notifications and stakeholder management of impacted users.
• Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees and team members, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
• Report to the VP Engineering & MSAT and be a member of the Engineering & MSAT leadership team.
• Act as anchor/on-site leader and provide leadership to License to Operate (LTO) topics within the facility (Safety and Quality).

Associate Director, GMP Facilities

Research Analyst

• Independently design and execute in vitro experiments to assess and develop novel assays/biomarkers, techniques and technologies to characterize cell therapy development processes
• Identify and determine appropriate ranges of (critical) assay process parameters to ensure robust, repeatable and accurate results with minimal supervision
• Ensure that experiments, analytical methods, and data meet the requirements for the intended use of assays, which includes characterization, lot release and comparability
• Perform flow cytometry, ELISA, analytical, cell-based, PCR-based and other assays as required
• Collect and analyze data from various assays, track and trend data, and establish specifications for critical process controls
• Author, review and approve SOPs, study protocols, reports and other scientific and quality documents
• Identify and evaluate new technologies and incorporate them into product quality assessments as appropriate
• Perform technology transfer of assays to the Quality Unit through training of personnel and support of further qualification/validation efforts
• Conduct hands-on laboratory work
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications)
• Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned

Principal Research Associate, Discovery Analytics

• This position will provide statistical strategic leadership in one or more therapeutic areas, including contribution to clinical development plans, protocol designs, statistical simulations, and regulatory interactions.
• Reporting to the Head of Biometrics, this position will also provide guidance to data management and statistical programming in data collection and analysis to support clinical programs within BlueRock, participate in the SOP development as well as oversee the activities of external vendor biostatistics teams to ensure deliverables are met with quality.
• Biostatistics representative in the Clinical Study Team
• Provides key contributions to the clinical development strategy and plan including but not limited to dose-finding strategy, design options, simulations to evaluate operating characteristics of study designs, and Go/No Go decisions.
• Provides technical leadership in the design, execution of clinical trials and statistical analysis plans.
• Plan and execute of exploratory analysis and statistical consultation within cross-functional teams.
• Generates and/or verifies sample size calculations and randomization schedules as needed
• Propose and implement innovative designs and methods to optimize drug development.
• Authors statistical sections of the clinical trial protocols
• Provides statistical support and oversight of Data Monitoring Committees and Independent Statistical Analysis Centers.
• Contributes to clinical study reports and regulatory documents
• Lead statistical oversight of CROs to ensure timely, high-quality deliverables aligned with regulatory standards and clinical development objectives
• Effective partnership with other functions to ensure integrated quantitative input into project
• Participates in other activities and meetings to support Biometrics as necessary

Associate Director, Biostatistics

Chief of Staff

• The Chief of Staff to the CEO enables the CEO to work effectively with internal and external stakeholders, drive strategic priorities, and ensure alignment across teams
• This is a highly strategic and facilitative role that requires a combination of focus and flexibility, as well as a willingness to play an active, behind-the-scenes role
• As the CEO’s trusted counsel, the COS must be a highly resourceful individual with strong emotional intelligence, self-motivation, excellent analytical and communication skills, and demonstrated strategic planning experience is a must
• The role is ideal for someone who thrives in complex environments, connects the dots quickly, and is energized by helping a team deliver results through thoughtful planning, coordination, and execution