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@grail.com
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2 phones found area 949
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LinkedIn matched
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Sam An is listed as Senior Director, Program Management at GRAIL, based in Camas, Washington, United States. AeroLeads shows a work email signal at grail.com, phone signal with area code 949, and a matched LinkedIn profile for Sam An.
Sam An previously worked as Senior Director, Program Management, Post Diagnosis Applications at Grail and Senior Director, Alliance Management at Dascena. Sam An holds Master Of Business Administration (Mba) from Ucla Anderson School Of Management.
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AeroLeads found 1 current-domain work email signal for Sam An. Compare company email patterns before reaching out.
-Proven track record in managing and developing medical device products for global launches (US, EU, Canada,Japan, South Korea, etc.)-Extensive experience managing partner alliances and contracting, including both industry and academic collaborators -Broad based knowledge encompassing product development, design control, regulatory submissions (510k, pre-submissions, IDE, IND, PMA, etc.), software development and risk management to properly guide successful product launches and updates-Experience managing several complex Class III Companion Diagnostic Assay Development to align with Drug Development, including full PMA submission/approval-Experience working under various perspectives (Diagnostic, Biotech, and Pharmaceutical) to really understand entire product concept from feasibility leading up to commercialization and regulatory submissions-Experience developing medical device/drug combination product, including early stage drug development and related nonclinical & CMC work-Experience with developing machine learning software algorithm as a SaMD (software as a medical device)-In depth knowledge of Quality System Regulation 21 CFR 820 and subpart C, Design Control and ISO 13485-Experience building up and managing program management teams to scale with company growth & needs
Listed skills include Biotechnology, Medical Devices, R&D, Product Launch, and 17 others.
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Menlo Park, CA, US
-Manage high profile companion diagnostics collaboration with a major pharmaceutical partner-Manage preparation and setup for pivotal global phase 3 clinical trials, including overseeing FDA and IVDR submissions-Oversee budget, timelines, milestones for the entire program-Manage earlier stage research collaborations with pharmaceutical partners on specific.
San Francisco, CA, US
-Managed high profile collaboration with co-developing a machine learning/artificial intelligence SaMD (software as a medical device) with a medical device partner in digital health-Led internal efforts to identify a candidate to take through the FDA with SaMD, including clinical validation design and regulatory strategy-Tasked with developing internal.
San Diego, CA, US
-Managed development of 4 separate programs encompassing 2 separate paired drug/device combination programs, IVD diagnostic coupled with medical device, and LIMS implementation for Precision Medicine unit-Collaborated with CMC and nonclinical leads to ensure internal drug development related activities are on track -Oversaw budgets, critical paths.
San Diego, California, US
-Managed development of entire portfolio of NGS (next-gen sequencing) based IVD diagnostic assays for hematological cancers on multiple platforms (Thermo Fisher and Illumina), includes timelines, budgeting, clinical trial planning, validation design, etc.-Managed external collaboration efforts and alliance management with high profile clients/partners to.
Santa Clara, CA, US
-Devised and compiled comprehensive work plans for collaborations with pharmaceutical clients-Managed development and launch of companion diagnostics assays for oncological drugs and/or candidates (2 successful PMA approvals tied to PD-L1 immunotherapy)-Managed client pharmaceutical partner relationships to ensure proper alignment of goals and.
Secaucus, NJ, US
-Managed launch of 6 molecular diagnostics products including 3 FDA 510k cleared products currently on the market-Led various product development teams under adherence to design control to deliver multiple products-Managed Core Teams consisting of representatives from R&D, Regulatory, QA/QC, Marketing, Operations, and Clinical Affairs from product concept.
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Sam An works for GRAIL.
Sam An is listed as Senior Director, Program Management at GRAIL.
AeroLeads has found 1 work email signal at @grail.com for Sam An at GRAIL.
AeroLeads has found 2 phone signal(s) with area code 949 for Sam An at GRAIL.
Sam An is based in Camas, Washington, United States while working with GRAIL.
Sam An has worked for Grail, Dascena, Biora Therapeutics, Invivoscribe, Inc., and Agilent Technologies.
You can use AeroLeads to view verified contact signals for Sam An at GRAIL, including work email, phone, and LinkedIn data when available.
Sam An holds Master Of Business Administration (Mba) from Ucla Anderson School Of Management.
Sam An is listed with skills including Biotechnology, Medical Devices, R&D, Product Launch, Strategy, Product Development, Cross Functional Team Leadership, and Commercialization.
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