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-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
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Senior Director, Program Management, Post Diagnosis ApplicationsGrail Jun 2022 - PresentMenlo 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 applications -
Senior Director, Alliance ManagementDascena Jan 2022 - Apr 2022San 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 program management capabilities to align with company’s needs -
Director, Project Management, Precision MedicineBiora Therapeutics Mar 2019 - Jan 2022San 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, timelines, and milestones for all development programs-Managed external vendors/collaborators/consultants to ensure proper tracking of all efforts and related progress-Managed alliances with external major pharmaceutical partners on internal drug delivery platform -
Director, Special Projects (Ngs Oncology Program Management And Alliance Management)Invivoscribe, Inc. Jul 2015 - Mar 2019San 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 ensure alignment-Led sPMA approval of FLT3 companion diagnostic -Worked with senior management on product strategies, portfolio planning, and launch preparations-Led the formation and management of team of project managers to align with company growth -
Project Manager, Companion DiagnosticsAgilent Technologies Mar 2012 - Jul 2015Santa 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 objectives-Led cross functional teams including marketing, R&D, Regulatory, Clinical, and Quality for class III medical device development -Devised and maintained project budgets, milestones, resources, and strategy -
Project Manager, New ProductsQuest Diagnostics Dec 2006 - Mar 2012Secaucus, 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 to commercialization-Served successfully as the main product development contact during various regulatory and quality audits -
Associate ScientistLife Technologies Nov 2002 - Dec 2006Waltham, Ma, Us -
Graduate Research InternAllergan Jun 2001 - Oct 2002Dublin, Coolock, Ie
Sam An Skills
Sam An Education Details
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Ucla Anderson School Of ManagementMaster Of Business Administration (Mba) -
Uc IrvineBiotechnology
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Uc IrvineBiological Sciences
Frequently Asked Questions about Sam An
What company does Sam An work for?
Sam An works for Grail
What is Sam An's role at the current company?
Sam An's current role is Senior Director, Program Management.
What is Sam An's email address?
Sam An's email address is ss****@****ail.com
What is Sam An's direct phone number?
Sam An's direct phone number is +194998*****
What schools did Sam An attend?
Sam An attended Ucla Anderson School Of Management, Uc Irvine, Uc Irvine.
What skills is Sam An known for?
Sam An has skills like Biotechnology, Medical Devices, R&d, Product Launch, Strategy, Product Development, Cross Functional Team Leadership, Commercialization, Assay Development, Management, Design Control, Product Management.
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