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Field: clinical monitoring & operations in oncology & immunotherapies, phase 1-3. Broad small molecule and antibody infusion treatments across many tumor types. Mr. Duran's other core skill areas include inspection-ready TMF maintenance (Veeva Vault), vendor & project management (RAVE EDC, imaging, labs, IRT), clinical supplies packaging & labeling, to CTA contracts & budgets, and clinical finance reconciliation (accruals, invoicing, payments). Past program experience includes a variety of therapeutic tx modes, such as rare disease enzyme replacement therapy, monoclonal antibodies & antibody-drug conjugates (ADC), and CpG-containing immunostimulatory DNA sequences (CpG-ISS). Outside the clinical setting, his other core experiences were within Technical Operations to coordinate end-to-end clinical CMO labeling and packaging in rare disease trials. Prior to that transition were 10 years in Immunologic R&D in protein technologies, optimizing and executing cell- and protein-based assays, from preclinical/toxicology sample analyses to high-throughput FACS screening. A California native, Mr. Duran is a clinical monitor covering the West Coast.
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IqviaUnited States -
Senior Cra 3Iqvia Oct 2022 - PresentDurham, North Carolina, UsPhase 1-3 Oncology Clinical Trial Monitoring from start-up to closeout -
Senior CraVera Therapeutics, Inc. Jun 2022 - Oct 2022Brisbane, California, UsPh.3 randomized, double-blinded, placebo-controlled trial evaluating efficacy and safety of atacicept in subjects with Lupus Nephritis (LN). Atacicept is an investigational recombinant fusion protein that binds to the cytokines B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to autoimmune diseases, including LN. -
Senior CraCalithera Biosciences Jan 2022 - Jul 2022South San Francisco, Ca, UsCX-228-301 study startup sapanisertib in r/r sqNSCLC in NFE2L2/KEAP1 mut NGS-screened subjects -
Clinical Research Associate IiCalithera Biosciences Jan 2021 - Dec 2021South San Francisco, Ca, UsStudies: ENTRATA, CANTATA, KEAPSAKE, CX-228-301 -
Clinical Research AssociateCalithera Biosciences Jun 2018 - Dec 2020South San Francisco, Ca, UsSupporting global operations for Calithera's Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial comparing CB-839 in Combination with Cabozantinib v. Placebo in Patients w. Advanced or Metastatic Renal Cell Carcinoma (RCC)Locations: US / UK / EU (ES, IT, FR, DE,) / AU / NZ -
Specialist, Clinical Packaging OperationsBiomarin Pharmaceutical Inc. Jun 2017 - Jun 2018San Rafael, Ca, UsManaged CMOs and clinical supply vendors, coordinating end-to-end clinical drug product labeling and packaging processes over all programs and protocols, adhering to foundational cGMP regulations, and communicating across internal teams and business sites, supporting joint Technical- and Clinical-Operations’ timelines. -
Coordinator, Clinical Packaging OperationsBiomarin Pharmaceutical Inc. Sep 2016 - Jun 2017San Rafael, Ca, UsManaged end-to-end primary and secondary labeling and packaging processes from initiating content-design requests with external vendors, and shepherding document approvals within QA and Regulatory, to coordinating delivery timelines among parallel Supply Chain and Manufacturing Fill/Finish activities. -
Senior Research AssociateAgensys, Inc. / Astellas Pharma Us, Inc. Jul 2012 - Aug 2016Negotiated an expanded scope developing individual contributions from R&D to within ClinOps, training in an inter-departmental role on ph. I/II oncology trials. Within R&D Scope: Designed bead-based, multiplex bioassays assessing M13 bacteriophage, and phage display-derived antibodies, as well as bi-specific antibody characterization under the internal Antibody Engineering Development Program. Collaborated with Chemistry to conduct cell viability/cytotoxicity assays on novel, in-house compounds, expanding a series of new microtubule-inhibitor in vivo ADC studies.
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Research Associate IAgensys, Inc. / Astellas Pharma Us, Inc. Oct 2008 - Jul 2012Developed HTS assays to characterize serum-, cell supernatant-, and purified-mAbs across protein(s)/protein families for nomination to product candidates for further drug development.
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Research Associate IDynavax Technologies Corp. Jun 2006 - Sep 2008Emeryville, Ca, UsDeveloped and conducted Preclinical assays for IND-enabling studies in the Toll-like Receptor (TLR)-based, immunomodulatory pipeline; served dual functionality in Preclinical R&D and Research QA. Supported preclinical data based on Immunostimulatory Sequences (ISS) of CpG Oligodeoxynucleotides (ODN) immunomod. platform, to advance programs in Ragweed allergy, Hepatitis B, and Non-Hodgkin's Lymphoma. (See www.aacrjournals.org link: Acknowledgements, p. 5633) -
Staff Research Associate IUniversity Of California, Berkeley Jan 2006 - May 2006Berkeley, Ca, UsStaff Research Associate for the Molecular and Cellular Biology Upper Division Lab in Immunology, generating cell lines, preparing class materials, managing lab supplies, improving operations manual, and optimizing core data results to directly support undergraduate study.
Nick Duran Education Details
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University Of California, BerkeleyMolecular And Cellular Biology - Immunology
Frequently Asked Questions about Nick Duran
What company does Nick Duran work for?
Nick Duran works for Iqvia
What is Nick Duran's role at the current company?
Nick Duran's current role is Senior CRA 3.
What is Nick Duran's email address?
Nick Duran's email address is nd****@****era.com
What is Nick Duran's direct phone number?
Nick Duran's direct phone number is 151087*****
What schools did Nick Duran attend?
Nick Duran attended University Of California, Berkeley.
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