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Vice President/Senior Vice President, Regulatory Affairs
1 month ago
Vice President or Senior Vice President, Regulatory Affairs & Quality AssuranceHybrid Role - San Francisco Bay AreaMeet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients. Our client is focused in the Heme/Onc space - you'll be reporting into C-Suite and will be heading up Reg and Quality for the organization. Additional details can be provided via phone call.Key ResponsibilitiesLead Regulatory Affairs and Quality Assurance functionsManage all aspects of Regulatory submissions (IND/CTA, NDA/BLA/MAA)Manage FDA (and ex-US Health Authority) interactionsKey Qualifications20+ years of industry experience, minimum 10 years of management/leadership experienceOncology experience requiredFull development cycle experience required (pre-IND through commercial)Startup experience highly preferredPlease reach out to Ryan Moran to setup a confidential conversation:: ryan.moran@peoplewithchemistry.com#J-18808-Ljbffr
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Vice President, Clinical Operations
1 week ago
Emeryville, United States 4D Molecular Therapeutics Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...
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Vice President, Clinical Operations
2 weeks ago
Emeryville, United States 4D Molecular Therapeutics Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...
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Vice President, Clinical Operations
3 weeks ago
Emeryville, California, United States 4D Molecular Therapeutics Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...
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Vice President, Clinical Operations
1 week ago
Emeryville, California, United States 4D Molecular Therapeutics Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...
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Regulatory Affairs Manager
3 weeks ago
Emeryville, United States Alameda Health System Full timeSummary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CDPH...
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Senior Director CMC
1 month ago
Emeryville, California, United States DermBiont Full timeOrganization:DermBiont's mission is to become the world's leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent skin diseases. The company aims to impact the root causes of skin diseases through the development of first-in-class targeted therapeutics with well-defined mechanisms of...
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Senior Director CMC
1 week ago
Emeryville, California, United States DermBiont Full timeOrganization:DermBiont's mission is to become the world's leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent skin diseases. The company aims to impact the root causes of skin diseases through the development of first-in-class targeted therapeutics with well-defined mechanisms of...
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VP of R&D
1 month ago
Emeryville, California, United States Fauna Bio Full timeFauna BioVP of Research and DevelopmentCompany Description:Fauna Bio is using computational and functional pipelines to develop therapeutics from the extreme physiology of mammals. Our expertise in translational medicine, hibernation biology and cross mammalian biology/bioinformatics make us uniquely positioned to take advantage of the wealth of genomic...
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Senior Director CMC
2 weeks ago
Emeryville, CA, United States DermBiont Full timeOrganization: DermBiont's mission is to become the world's leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent skin diseases. The company aims to impact the root causes of skin diseases through the development of first-in-class targeted therapeutics with well-defined...
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Senior Director, Global Regulatory Lead
1 week ago
Emeryville, United States BeiGene Full time**General Description** + The Senior Director, Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage...
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Emeryville, United States BeiGene Full time**General Description:** The Executive Director, Clinical Development will effectively lead BeiGene clinical assets through successful development of early and late phase clinical development strategies and deliverables in partnership with multiple functions across the organization, and with external academicians and collaboration partners. The candidate...
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Emeryville, United States BeiGene Full time**General Description:** The Executive Director, Clinical Development will effectively lead BeiGene clinical assets through successful development of early and late phase clinical development strategies and deliverables in partnership with multiple functions across the organization, and with external academicians and collaboration partners. The candidate...
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Emeryville, United States BeiGene Full time**General Description:** The Executive Director, Clinical Development will effectively lead BeiGene clinical assets through successful development of early and late phase clinical development strategies and deliverables in partnership with multiple functions across the organization, and with external academicians and collaboration partners. The candidate...
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Manager, Business Development
4 weeks ago
Emeryville, United States Dynavax Technologies Full timeThis position can be 100% remote. Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified...
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Director, Global Regulatory Lead
1 week ago
Emeryville, United States BeiGene Full time**General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage...
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Medical/Scientific Director, Medical Affairs
3 weeks ago
Emeryville, United States BeiGene Full time**General Description:** The **Scientific Director or Medical Director, Medical Affairs - Americas** will support BeiGene Clinical and Medical assets by successful execution of medical affairs programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. The candidate...
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Medical/Scientific Director, Medical Affairs
1 week ago
Emeryville, United States BeiGene Full time**General Description:** The **Scientific Director or Medical Director, Medical Affairs - Americas** will support BeiGene Clinical and Medical assets by successful execution of medical affairs programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. The candidate...
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Emeryville, United States Grifols Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Emeryville, United States BeiGene Full timeThe Senior Director, Strategic Corporate Communications, North America, will help to shape and execute strategic communications that advance BeiGene’s vision and mission, commercial priorities and public affairs activities in North America. The successful candidate will be able to create insight driven communication plans and surround sound campaigns that...
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Emeryville, United States BeiGene Full timeThe Senior Director, Strategic Corporate Communications, North America, will help to shape and execute strategic communications that advance BeiGene’s vision and mission, commercial priorities and public affairs activities in North America. The successful candidate will be able to create insight driven communication plans and surround sound campaigns that...