BlueRock Therapeutics
Remote Jobs
3 Jobs
BlueRock is recruiting a key member of the Clinical Development group to support and direct preclinical, translational IND-enabling, and clinical development activities of the neurology programs. In this newly created role, the Medical Director Neurology will be charged with providing scientific and medical leadership and support for BlueRock’s neurology programs. 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
BlueRock is recruiting a key member of the Clinical Development group to support and direct preclinical, translational IND-enabling, and clinical development activities of the neurology programs. In this newly created role, the Associate Medical Director Neurology will be charged with providing scientific and medical leadership and support for BlueRock’s neurology programs. 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
The Head of Medical Writing will provide strategic and operational leadership for all Medical Writing activities to support BlueRock’s portfolio, from early development through product registration. Accountable for establishing and overseeing a cohesive, scalable Medical Writing function that delivers high-quality regulatory documents aligned with BlueRock’s global strategy, development timelines, and corporate priorities. Develop and lead an internal medical writing team, oversee vendor partnerships, and serve as a key strategic partner to various departments. Help shape future-state capabilities, including AI-enabled medical writing, platform-based content reuse, and collaboration models with Bayer colleagues. Define and own a Medical Writing strategy and roadmap aligned with BlueRock’s pipeline, regulatory milestones, and long-term growth. Establish standards, processes, and governance to ensure consistency, quality, and inspection readiness across all Medical Writing deliverables. Partner with Regulatory Affairs leadership to ensure integration of Medical Writing into regulatory strategy, Agency engagement, and submission planning. Drive a platform-based approach to document development for efficiencies and content reuse. Represent Medical Writing in cross-company forums as needed. Operational Excellence Provide oversight and accountability for all Medical Writing deliverables across BlueRock’s portfolio. Ensure delivery of documents that are on time, of high quality, and aligned with evolving global regulatory expectations. Identify opportunities to improve speed, quality, and scalability of document development. Lead resource planning (internal FTEs and external medical writing vendors) to support current and future program needs. Oversee and manage vendors and consultants to ensure consistent value, quality, and alignment. Serve as escalation point for complex document development challenges. Build, lead, and develop a high-performing internal Medical Writing team. Provide coaching, mentoring, and performance management to support professional growth and retention. Foster a culture of accountability, collaboration, and continuous improvement. Lead initiatives to modernize Medical Writing activities, including evaluation and pilot implementation of AI-enabled authoring, QC reviews, and content reuse tools. Define and manage collaboration models with Bayer, including potential shared services and/or AI-enabled pilots.