It continues to be an exciting time for BlueRock Therapeutics as the company advances cutting edge cellular therapies to positively impact patients’ lives across multiple disease areas.

In this newly created and highly visible role, the Director/Senior Director of Clinical Pharmacology, Cell Therapy, will support developing internal and externally partnered programs in the novel cell therapy modalities. This role will provide clinical pharmacology strategy to teams from nonclinical development through early phase to late phase and regulatory submissions.  

This role will assess and build the required clinical pharmacology and related capabilities in this novel space of cell therapy modalities. This role is expected to contribute and partner with highly productive, cross-functional teams (such as research, nonclinical development, regulatory, genome engineering, CMC, clinical development and operations, and IP) within a dynamic matrixed environment. They will manage partnerships with BlueRock’s academic founders as well as internal and external research sites spanning company locations in Berlin, Toronto, New York, and Cambridge. The position will be based in Cambridge, MA.

Responsibilities:

• The overarching goal and all efforts are to direct advancing cell therapies into and through development with the ultimate objective of global regulatory approval.
• This role will be the primary point of accountability for all programs and will provide scientific input as the Clinical Pharmacology SME and will be responsible for assessing and building the required capabilities to execute on the rapidly growing pipeline.
• Partner with key stakeholders in discovery, preclinical, biostatistics, CMC, and clinical development to develop and apply models to understand targeted biological pathways and interactions of novel cell therapy modalities.
• Assess pharmacology data to address program questions and provide scenarios to the program team to guide decision making (e.g., translation of preclinical efficacy to clinical therapeutic dose, clinical dose range justification, biomarker identification, biodistribution of target cells, and efficacy/toxicity predictions).
• Conduct extensive literature review to identify suitable mechanistic elements, interactions, and sub-modules for incorporation into disease models.
• Identify areas where advanced modeling may add value and work with collaborators to ensure right approach and tools are used for novel cell therapy modalities.
• Stay abreast with emerging literature and science in the systems biology/pharmacology modeling and simulation sciences for cell therapies.
• Lead or oversee development of clinical pharmacology related sections for protocols, study reports, regulatory submissions/interactions, and other relevant documents.
• Provide strategic input into the research direction of programs by interacting with external academic collaborators and internal leadership teams.
• Contribute to strategic evaluation of diseases of interest to BlueRock and integration in the development vision and planning.
• Support target cell biodistribution assays in nonclinical models during research and development stages, review protocols and reports, interpret data, and compile biodistribution information in regulatory documents.  
• Establish, grow, and maintain key relationships with global leaders in clinical pharmacology for cell therapy, and translational medicine fields, including BlueRock Advisory Boards.
• Manage timelines and maintain department budget.
• Mentor clinical pharmacology scientists and develop innovative clinical pharmacology methods, teamwork and quality.
• Participate in establishment of efficient processes, standards and SOPs.
• Participate in writing publications and making scientific presentations consistent with development strategies and publication plan.

Minimum Requirements:

• PharmD or PhD in Clinical Pharmacology or related field, or degree commensurate with experience
• Pharmaceutical/biotechnology industry experience with a demonstrated track record of publications and scientific research
• Experience in cell and/or gene therapy is a plus
• Familiarity of regulatory guidance (e.g. ICH, FDA, EMA) and experience in GCP and GLP studies
• Proven ability to lead by example within a collaborative, dynamic, high growth culture, championing and advancing novel concepts within cross-functional matrixed teams
• An innovative, results-oriented, solutions focus and critical thinking skills
• The motivation to build a culture of pioneering science with aspirations to develop products that will change the lives of people with serious diseases
• Regulatory interactions experience
• Innovative focus and ability to champion and advance novel concepts

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