Bradley Katz Email & Phone Number

Lexington, Massachusetts, United States

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.

Lexington, Massachusetts

Lexington, Ma (Usa)

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

Greater Boston Area

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.

Lexington, Ma

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.

Lexington, Ma

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.

Lexington, Ma

Role Summary: Manage the microbiology aspects of Phase II-IV clinical trials for multiple anti-bacterial products and lead teams of cross-functional experts (internal and external) in microbiology related projects.

Lexington, Ma

Master Of Science (M.S.), Microbiology, Summa Cum Laude

Thesis: Inactivation of hepatitis A HM-175/18f, reovirus T1 Lang and MS2 during alkaline stabilization of human biosolids.

Bachelor Of Science (B.S.), Medical Laboratory Science, Summa Cum Laude

Activities and Societies: Golden Key National Honor Society Certified, Medical Technologist, "MT(ASCP)", trained in medical microbiology.