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Job Description Aerovate (AVTE) is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of people with rare cardiopulmonary disease.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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8-10 years of commercial pharmaceutical experience, preferably in biopharmaceuticals & rare disease products. In addition, this role is responsible for cultivating a close relationship with cross functional team colleagues in Sales, Medical Affairs, Marketing, Market Access, Contracting, Customer Support & Operations.
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Maintain clinical, scientific, and technical expertise in rare disease therapeutic areas. 3+ years of related work experience (clinical, managed care, or industry experience) and prior rare disease experience preferred.
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Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. Non-oncology experience required, rare disease preferred.
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Oversee our relationship with the Rare Disease Company Coalition. This role will play a key role in the evolution of our organization and lead the patient affairs strategy throughout the continuum of preclinical and clinical development to commercialization for Astria’s pipeline of programs.
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Senior Medical Science Liaison, Rare Disease (San Francisco, Northern California) page is loaded Senior Medical Science Liaison, Rare Disease (San Francisco, Northern California) Apply remote type Field Worker locations US - California - San Francisco time type Full time posted on Posted Yesterday job requisition id R-177094 Career Category Medical Affairs Job Description HOW MIGHT YOU DEFY IMAGINATION.
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Successful product launches within oncology and rare disease, both US and ex-US. Prior experience in oncology and/or rare disease required. This person will be responsible for establishing the Medical Affairs vision, overseeing the organizational build including cross-functional integration, developing strategies and supporting tactical execution for a wide array of sub-functions (Strategy and Operations, Field Medical Affairs, Medical Communications, Evidence Generation and HEOR, Patient Advocacy), interacting with senior leadership, and taking a "hands-on" approach in a lean organization.
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Clinical or industry experience in sickle cell disease, thalassemia, gene therapy, bone marrow transplant, or rare diseases (blood disorders). bluebird bio is seeking an accomplished and adaptable Director Medical Affairs to join the medical affairs team, focused on our gene therapy programs for Sickle Cell, Beta Thalassemia, and CALD. You will be joining a passionate and committed flock, flying closely with medical birds as well as the cross functional teams.
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Medical Science Liaison, IgG4 - Rare Disease. Rare Disease therapeutic area expertise. JOB ID: R-185495 LOCATION: US - Ohio - Cleveland WORK LOCATION TYPE: Field Worker DATE POSTED: Mar. 27, 2024 CATEGORY: Medical Affairs SALARY RANGE: 162,414.00 USD - 185,108.00 USD.
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Advanced knowledge of sickle cell disease (SCD), rare disease, and/or healthcare policy. This is a leadership role and will work closely with the Co-Founder and President to develop and implement government affairs public policy work.
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Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus. You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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Experience with regulatory aspects of rare disease products. BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience and at least twenty (20) years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry, or equivalent.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity.
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Prior experience in rare disease is required. This role will collaborate across the Commercialization teams including (and not limited to) Marketing, Medical Affairs, Market Access and Commercial Operations.
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