Jonathan Baden Email & Phone Number

Raritan, Nj, Us

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Responsible for the development and execution of companion/complementary biomarker diagnostic strategy for BMS product development and brand teams. Provides evaluation, strategy, development and delivery of diagnostic products that enhance value of the pharmaceutical product profile-Directs Pharmacodiagnostics on asset Development, Brand, and Translational Medicine teams for which companion, complementary, or other in vitro diagnostic development is within strategy.-Responsible for developing the overall Pharmacodiagnostic strategy and Leads Pharmacodiagnostics matrix subteams to enhance the value of the assets through incorporation of diagnostic biomarkers into exploratory, clinical, regulatory, and Medical/Commercial strategies.- Provides strategic direction to business development led search, evaluation and transactions for diagnostic partnering.- Coordinates all executable activities between the Development/Brand team and external diagnostic partners. -Responsible or delivery of diagnostic partner critical milestones, e.g. technical development and validation, clinical validation, and regulatory activities.- Participates in commercial planning and medical strategy as related to the diagnostic product.- Provides internal and external subject matter expertise for BMS pharmacodiagnostic and precision medicine activities:- Acquires and disseminates precision medicine knowledge for organizational learning and capability; Represents BMS PDx to external stakeholders including health authorities, medical customers and presentations at scientific meetings.

Raritan, New Jersey, Us

• Developed and led IVD strategies aligned with therapeutic disease areas for the development of molecular (NGS, PCR) and immuno (IHC, ELISA) diagnostics for stand-alone Dx and companion Dx.• Managed diagnostic partnerships and served as the single point of contact to execute on jointly defined deliverables, from assay development to launch.• Provided technical expertise and orchestrated cross functional alignment with biomarker leaders, clinical affairs and regulatory representatives on the successful implementation of diagnostic assays.• Established accurate development plans and budgets for the oversight of diagnostic development, clinical trials, and regulatory (FDA & CE) submissions. • Coordinated program decisions, tracked strategic risks, identified and captured action items, and communicated to management on behalf of the core team.• Managed a multi-site team of Ph.D and non-Ph.D scientists and engineers focused on and accountable for the Assay and System R&D commitments.• Executed landscape assessments and technical due diligence on emerging technologies and competitor activity.

• Managed a large team (15) of Ph.D and non-Ph.D scientists focused on and accountable for the Assay R&D commitments for molecular & immuno diagnostics• Proven accountability for management, execution and resolution of assay process for all stages of the product development life cycle, from prototype through commercialization.• Established collaborations and strong relationships with internal and external development partners, KOLs and academic leaders• Identified growth opportunities and assessed emerging technologies and competitor activity• Experience with clinical trial design, verification & validation programs, pre-IDE submission and FDA guidance documentation• Responsible for the programs plans and budgets for multiple track projects in Assay R&D

•Project lead for optimization, development and technology transfer of products under design control from assay development to operations for nucleic-acid-based IVD and CE kits•Responsible for prioritization, planning, resource allocation and analysis of studies for process optimization, transfer activities and preclinical trials.•Involved in the technical due diligence to assess potential acquisitions and partnerships•Develop and execute publication strategy to condition marketplace prior to regulatory submission

•Worked as a bench scientist, technical lead, and core team leader for the design, optimization and validation activities for IVD, CE and ASR assays utilizing both PCR and chip platforms.•Lead the evaluation of platforms and enabling technologies for incorporation into current and future assay needs.•Served as Assay Development representative at external supplier audits involving Quality Affairs•Responsible for the discovery and feasibility of various potential biomarkers for diagnostic and prognostic assays. •Designed, optimized, and validated nucleic-based assays utilizing both PCR and chip platforms and incorporated chosen sample preparation, amplification, and detection technologies into assay design. •Molecular profiling of rare circulating tumor cells captured via immunomagnetic selection.

Rochester, Ny, Us

Signal Transduction- Characterized protein/protein interactions and associated functions in human, avian and murine chondrocytes.- Established primary cell cultures from mouse, rat and chicken tissue to develop animal models of human disease- Cloning, stable cell transfection and Immunoprecipitation of multiple constructs of engineered proteins.- Responsible for the discovery of signaling mechanisms and associated biomarkers involved in stem cell differentiation, bone formation, cartilage regeneration, and osteoarthritis.

Microbiology And Immunology

Biotechnology

Education record