• Senior Medical Director

    Astrix Technology (Boston, MA)
    …programs worldwide. + Ensure adherence to international clinical development and regulatory standards. **Qualifications:** + MD or MD/ PhD with specialization ... including RNA, genomic, proteomic, and imaging-based markers. + Contribute to global regulatory submissions (eg, INDs, CTAs) and provide medical input in alignment… more
    Astrix Technology (08/11/25)
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  • Senior Director, Translation Imaging Lead

    Bayer (Cambridge, MA)
    …and vendor relationships and that clinical and biomarker imaging activities adhere to regulatory and industry standards and ensures the regulatory acceptance of ... one of the following: a) Medical doctor (MD or MD/ PhD ) or imaging scientist ( PhD ) trained in...of imaging and clinical development in oncology; experiences with regulatory framework for biomarkers, and use of imaging for… more
    Bayer (08/15/25)
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  • Senior Principal Research Scientist

    AbbVie (Cambridge, MA)
    …drug substance and drug product development. + Experience developing global regulatory strategies including authoring regulatory submissions, and responding to ... position involves multi-disciplinary collaborations across Discovery, Development, Manufacturing, and Regulatory to execute and deliver material and information for… more
    AbbVie (05/30/25)
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  • Associate Vice President, Companion Diagnostics

    Merck (Boston, MA)
    …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... to stay up to date regarding industry trends and diagnostic regulatory requirements. **Essential Job Requirements:** + Develop end-to-end diagnostic strategy in… more
    Merck (08/19/25)
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  • Executive Director, Commercial Manufacturing

    Sumitomo Pharma (Boston, MA)
    …Team. + Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support ... company objectives. + Champion regulatory and technical documents for regulatory submissions...domestically and international if/when needed. **Education and Experience** + PhD or MS Chemistry, Biology, or related field is… more
    Sumitomo Pharma (08/02/25)
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  • Scientific Director, Cancer Immunology

    Bristol Myers Squibb (Cambridge, MA)
    …biology, immunology, biologics, translational research, and document preparation for regulatory health authorities. This includes an understanding of the impact ... of each of these areas on early and late-stage development. + **Track Record:** Proven track record of developing immune oncology assets from target concept to IND. Expertise in deploying relevant in vitro and in vivo biological assays to drive biologics… more
    Bristol Myers Squibb (08/22/25)
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  • Associate Director/Principal Medical Writer

    Sanofi Group (Cambridge, MA)
    …who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an ... in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to… more
    Sanofi Group (07/31/25)
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  • Process Development Senior Scientist - Synthetics…

    Amgen (Cambridge, MA)
    …technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. + May lead and develop a small group of scientists. ... 3 years of Scientific experience; Or + Doctorate degree PhD OR PharmD OR MD **Preferred Qualifications:** + ...to details in authoring methods, specifications, technical reports and regulatory filing documents **What you can expect from us**… more
    Amgen (07/20/25)
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  • Clinical Statistician, Associate Director

    Pfizer (Cambridge, MA)
    …manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful ... Provide scientifically rigorous statistical input into project development plans, regulatory submissions, interpretation of statistical results, study design, statistical… more
    Pfizer (08/08/25)
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  • Associate Director, Analytical Development…

    Takeda Pharmaceuticals (Lexington, MA)
    …lead a team to ensure analytical methods and strategies meet scientific, regulatory , and quality standards necessary for regulatory filings, commercial ... by Design (AQbD) principles, aligning with ICH Q14, ICH Q2(R2), and global regulatory expectations for biologics. + Lead technical assessments and risk analyses to… more
    Takeda Pharmaceuticals (07/02/25)
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