Jayant (Jay) Chonkar, Ms Email & Phone Number

Jersey City, Nj, Us

Basel, Baselstadt, Ch

Currently the operational lead for several Investigator Initiated Trials (IITs) in hematology for Scemblix® (ABL001, Asciminib), a product approved for third-line treatment of Ph+ CML. Also led the Managed Access Program (MAP) for Iptacopan in the US, whereby 7 patients were given the investigational product. Post-FDA approval of that product (Fabhalta®), I ensured a smooth transition of the patients of investigational to commercial supply.

Basel, Baselstadt, Ch

Worked in Oncology Medical taking on various responsibilities. Led Investigational Initiated Trials (IITs) for mature products like Promacta® and Adakveo®. This involves end-to-end management from concept stage to close-out: tracking milestones, maintaining eTMF & CTMS, drug supply / forecasting and budget activities. A key element of this is also cross-functional alignment with local and global colleagues, along with periodic engagement with investigators / sites. Previously managed IITs in the solid tumor space as well.An essential part of the job also revolved around managed access program (MAP), whereby Novartis provides access to investigational treatment for patients without alternative treatment options. Oversaw MAP requests - individual patient request (IPRs) & Cohort - for asciminib (ABL001). This involved approving requests, maintaining eTMF and shipping investigational product. Cohorts also involved reviewing site ICFs to ensure alignment with Novartis protocol. Through this process, more than 100 patients without treatment options were able to benefit from asciminib. Post-FDA approval and commercial availability, I ensured a smooth transition for those patients whose conditions fell under the FDA label. For those whose conditions did not fall under label, ensured that they were able to continue on the MAP program.I have conducted supporting activities for Novartis sponsored studies: reviewed ICFs, provided monthly updates with Newsletters, tracked enrollment, maintained eTMFs, raised queries in RAVE Medidata and distributed recruitment tools.

Basel, Switzerland, Ch

 Managed regulatory documents / milestone dates for 150 Managed Access Programs (MAPs) on an external data repository complying with a new working practice Reviewed medical profiles of 20 patients on a US-Sponsored trial, checked any discrepancies/deviations from protocol and sent to trial monitors for review Oversaw the transfer of 11 IITs to a small biopharmaceutical company for a divested compound; performed SAP reconciliation and transferred study documents Engaged in weekly cross-functional team meetings, ensuring the completion of tasks for an upcoming audit

Basel, Switzerland, Ch

 Conducted quality check of, uploaded and appropriately tagged over 200 missing regulatory documents from the main data repository, thereby resolving an audit issue Ensured the completion of SAE and SAP (financial) reconciliation for AML / CML trials, as well as for BCC trials; communicated with physicians in different trial sites for the same Coordinated with data management team to update milestone dates and key trial information in our internal dashboard, as well as for the material presented on clinicaltrials.gov Involved in cross-functional team meetings for kick-off of pipeline products and medical feasibility discussion of medical affairs concepts

Basel, Switzerland, Ch

 Led an online Site Initiation Visit, presenting to a physician, informing him about the protocol, design, and dosage of a clinical trial for patients with advanced breast cancer Achieved milestones in a critical trial, by reviewing informed consent forms, sending newsletters/emails reminding of enrollment, managing TMFs, resolving queries and shipping products Engaged in cross-functional teamwork across the company, and interacted with global counterparts to track milestones in designated trials and improve access to medicine Collaborated with fellow interns in researching on different aspects of cancer therapy and developed a PowerPoint presentation, which was presented to upper management

Miami, Fl, Us

Other; Hmx Fundamentals/Pro Online Certificate Program - Immuno-Oncology

Other; Hmx Fundamentals/Pro Online Certificate Program – Cancer Genomics And Precision Oncology

Ms, Clinical & Translational Research

Bachelor'S Degree, Chemistry

International Baccalaureate Diploma