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Sr. Manager/Associate Director, Medical Affairs

bridgebio · Remote - USA · Remote - USA
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<div class="content-intro"><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Mavericks Wanted</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></span></p> <p><span data-contrast="auto">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</span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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. </span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p></div><p><strong><span data-contrast="auto">What You'll Do</span></strong><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">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.</span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Responsibilities</span></strong><span data-ccp-props="{}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Support development and revision of Medical Information content in collaboration with the Medical Information lead and relevant subject-matter experts.</span><span data-ccp-props="{"201341983":0,"335559740":240}">&nbsp

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