Bradley Katz

Experience

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  Cubist Pharmaceuticals

  Jun 2005 - Jun 2015

  Role Summary: Lead and manage all aspects of multiple global grant programs (investigator initiated research, medical education and medical affairs sponsorships) and company sponsored research activities across the product portfolio.Role Highlights:• Lead and manage multiple, cross functional review committees determining the scientific and medical benefits of supporting strategically aligned research (grants and company sponsored activities).• Oversee process development, improvement and integration projects related to grants and grant management systems.• Create policy and procedural documents (charters, work instructions and standard business practices).• Author all program related communications to external requestors and internal stakeholders.• Manage the electronic requests management system (Polaris) and additional study databases/tracking documents.• Track and manage program budgets (payments and accruals) and provided routine financial forecasts to relevant parties. • Manage and forecast study drug supplies for clinical and pre-clinical research.• Effectively communicate grant program status and individual study progress to senior leaders. • Develop and negotiate legal agreements for grants and company sponsored research studies.• Ensure compliance with relevant local and federal laws as well as industry guidelines including applicable safety and payment data reporting. Show less

  • Program Manager, External Research and Grants, Global Medical Affairs

    Jun 2012 - Jun 2015

  • Sr. Research Associate I and II, Clinical Microbiology

    Aug 2008 - Jun 2012

  • Research Associate II, Clinical Microbiology

    Jun 2005 - Aug 2008
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  Merck

  Jul 2015 - Oct 2015

  Operations Manager, Cubist-Legacy IIS Program, Global Center for Scientific Affairs

  Role Summary: Lead the transition of Cubist Pharmaceuticals legacy investigator initiated studies and company sponsored research activities to Merck & Co., Inc.• Identify cross-functional and cross-company interdependencies and develop solutions to effectively integrate legacy, multi-product, research projects with minimal interruptions to ongoing studies. • Areas of focus include: development and execution of communication plans for internal and external stakeholders, budget consolidation/integration, data migration and process migration. Show less

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  BioBridges

  Oct 2015 - Dec 2015

  Investigator Initiated Research Consultant at ARIAD Pharmaceuticals

  Role Summary: Overseeing and optimizing the the global Investigator Sponsored Trial (IST) program for ARIAD Pharmaceuticals. Staffed by BioBridges:BioBridges manages the careers of clinical development professionals across all functional areas for emerging and established pharmaceutical, biotechnology and medical device companies. Founded by industry veterans, BioBridges unmatched level of market insight successfully aligns exceptional life science professionals with the programs that need them. The company’s scalable consultant management model provides the experience that works, and delivers the contributions necessary to advance science and produce breakthrough therapies. Show less

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  Shire

  Dec 2015 - Jul 2019

  Role Summary: Lead the strategic and operational responsibilities for global R&D Grants, IIRs, Financial (Fee For Service) Engagements and Cap Management across all therapeutic areas.Role Highlights: • Design and manage processes to ensure effective and efficient operational support and SOP compliance from submission to processing of requests• Define, harmonize and manage the Grants, IIRs, Financial Engagements, and Cap Management processes, in close collaboration with Global Medical Affairs, Legal, Compliance, and other R&D and Commercial stakeholders as appropriate• Define and track performance against key metrics, and ensure all Grants, IIRs, Financial Engagements, and Cap Management activities are properly documented and aligned with relevant guidance• Manage and develop a team of project managers, specialists, and external consultants as needed in performing the operations functions Show less

  • Head, HCP/HCO Engagements

    Mar 2017 - Jul 2019

  • Group Lead, Investigator Initiated Research and Laboratory Services (Director)

    Nov 2016 - Mar 2017

  • HCP/HCO Engagements Team Lead, Global Medical Affairs Operations, R&D Shared Medical Services

    Dec 2015 - Nov 2016
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  Takeda

  Jul 2019 - now

  Head, Medical Affairs Laboratory Services

  Direct a team of professionals that manage Takeda's anti-drug antibody and biomarker (ADAB) testing program for our lysosomal storage disorder enzyme replacement therapies, globally.