Live opening · Posted 14 hours ago
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About the role
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Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
What You'll Do
As the Senior Manager/Associate Director, Medical Affairs, reporting into the Executive Director, Skeletal Dysplasia, you will play a key role in the execution of Medical Affairs activities across the skeletal dysplasia portfolio. This role will have primary responsibility for medical review and MLR submissions, scientific content development, advisory board and company-sponsored symposium execution, Medical Information support, support for exploratory analyses of existing data and data generation opportunities, and management of external agency deliverables. You will independently drive assigned workstreams from development through approval and execution, while partnering closely with Medical Directors and functional leads on scientific and strategic decisions. This is a hands-on, individual-contributor role for someone who combines strong scientific judgment with disciplined project execution and can move complex Medical Affairs deliverables forward with limited oversight.
Responsibilities
Serve as a Medical Affairs reviewer for scientific and medical materials, ensuring scientific accuracy, appropriate interpretation of clinical data, consistency with source documentation, and alignment with approved scientific communications, and escalate questions of clinical interpretation or strategic positioning to the responsible Medical Director.
Initiate, submit, and independently manage Medical Affairs materials through the Medical, Legal, and Regulatory (MLR) review process, including submission preparation, reference documentation, incorporation of reviewer comments, version control, resubmission, and tracking through final approval.
Partner with the Medical Information lead to identify needs for new or updated response materials and review Medical Information letters for scientific accuracy, appropriate data interpretation, and consistency with current evidence.
Support development and revision of Medical Information content in collaboration with the Medical Information lead and relevant subject-matter experts.
Manage execution of Medical Affairs advisory boards, including advisor coordination, timelines, pre-read materials, meeting logistics, agency management, MLR review, and post-meeting deliverables, in partnership with Medical Operations and other internal teams.
Work closely with Medical Directors to support development of advisory board objectives, agendas, discussion questions, presentations, and scientific content.
Support development and execution of company-sponsored scientific symposia, working with Medical Directors, external faculty, and KOLs to develop presentations and scientific content and to coordinate faculty review, MLR submission, revisions, and finalization of materials.
Support Medical Directors and Clinical Development in exploring and conducting novel analyses of existing clinical trial, natural history, and real-world data (e.g., post hoc, subgroup, and descriptive analyses), including helping frame analysis questions, coordinating with Biostatistics and Data Management, and summarizing results for internal review and scientific communications.
Assist in identifying and evaluating data generation opportunities (e.g., investigator-initiated studies, registries, chart reviews, and real-world evidence collaborations
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