Served as the primary point of contact and lead for the operational management of clinical programsManaged KOLs, CROs and vendors in accordance with in house SOPsHelped in due diligence activities before acquisition by JNJPlayed a key role in developing strategy, feasibility, timelines and budget to start the FIH studyWorked with JNJ to transition the in house Proteologix clinical programs to the JNJ systemsPut in strategies to build efficiencies with in JNJ to get the study started in 50% of the usual JNJ time

Director, Clinical Operations: Program lead on all Clinical pharmacology studies for ESK-001 and Program lead on ESK-001 in Autoimmune disease (Systemic Lupus Erythematosus)Responsible for developing strategy, feasibility assessment, budget and resource allocation to meet program goalsProvided oversight and supported study execution team leads to execute studies at the highest standards per ICH/GCP guidelines. All studies were completed within timelines and budgetServed as a point of escalation and Subject matter expert on clinical operations for Clinpharm and SLEprograms Provided oversight and supported Study Leads in the CRO/Vendor selection process review ofScope of Work, budgets and helped contract negotiations and executionsStudy execution: Executed 9 Clinpharm studies in 1 year from RFI to CSR completion in addition to starting 20 countries 150 site phase 2 SLE trial and achieved site activations and FPFD to meet corporate goal.Hired and managed a team of 2 AD, 2 CTMs and 3 CTAs FTEs in addition to 4 consultants.Actively led CRO selection, budget negotiations, KOL identifications, PI outreach, CDAs and early discussionsProposed study timelines and facilitated timely preparation of essential documents for filing and assisted in responding to regulatory authorities in the US, EU, LATAM and APAC.Prepared reports on clinical program benchmark key performance indicators (KPIs) such as, but not exclusive to clinical synopsis development, finalization of clinical protocols, CRO contracting, patient screening, first patient enrolled, last patient enrolled, data lock, report finalizationWorked with KOLs and CROs to implement ePROs and eCOAs needed for primary and secondary endpointsHelped with BOD slides and updated project status to upper management,Managed coordination of Study team and Cross-functional team dependenciesWorked with the study lead and CRO to assess risk management and mitigation plan for study timelines and conduct

Autoimmune diseases including Lupus, Scleroderma, and Multiple Sclerosis: Led activities for CRO identification, selection, and Budget negotiation Proposed novel study design, prepared Pre IND-Briefing document and obtained no objection from FDA to move forward with the study Proposed study timelines and facilitated timely preparation of essential documents for filing, including study protocols, ICFs, pharmacy and lab manual Managed coordination of Study team and Cross-functional team dependencies with weekly study updates and leading study discussions Program lead on AML/MDS project: Significantly increased study enrollment by PI and site outreach and closed enrollment 6 months ahead of time. Instituted sound clinical practices to improve conduct of the study Planned on starting the Phase 3 study with RFI and CRO selection Worked on getting other studies (LR MDS) started by contributing to Program management, protocol development and early regulatory talks

• Study execution team lead on three phase 2 and one phase 1 global clinical programs from study strategy, initial study synopsis through CSR and final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.)• Manage aspects of a clinical trial from start-up through completion, including writing protocols, informed consent documents and CSR (2 protocols and 2 CSRs to date).• Manage on-time execution and conduct of clinical studies, including contributing and tracking the development of budget, milestones, and timelines. Maintain overall quality, safety, and compliance throughout the duration of the clinical studies and program (one RFP, several vendor contracts and scope change orders).• Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.• Provide recommendations in vendor identification/qualification/selection and oversight with proven track record of successful execution and study completion activities.• Contribute to or lead the systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eCOA, etc.)• Understanding of how to review, oversee and deliver the trial endgame, which is the data and statistical analyses by critically assessing data to detect trends and outliers to efficiently direct resources and attention to correct problems early.• Awareness of disease/ treatment landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications, as necessary. Modified existing LN strategy and study design to allow us to reach the NDA filing goal two and half year early.• Creatively approach challenges and problem resolution to optimize the conduct of clinical trials. In the face of COVID-19, updated protocols and conducted studies using remote monitoring and instituting remote visits using telehealth, home health nursing, etc.

• Managed four global studies in oncology two phase 1 and one phase 2 and a pivotal trial from startup through maintenance and closure activities; manage subject enrollment, selection and management of CROs and vendors; interface with Cross-functional leads to ensure clinical trial progress; and develop biomarkers that transition into companion diagnostics.• Executed clinical trial recruiting patients based on complex biomarkers to file for a companion diagnostic.• Authored sections of Investigator’s Brochures, clinical trial protocols, amendments, informed consent forms, annual progress reports, clinical study reports, and other required documents; develop and review Monitoring Plans, Case Report Forms, Protocol Deviation Management Plans.• Review monitoring visit reports to ensure clinical trial site performance, quality, and compliance; identify, troubleshoot, and resolve issues pertaining to site monitoring.• Conduct pre-study qualification, site initiation to ensure appropriate training, clinical quality, and data integrity; and perform clinical trial-specific tasks including contract negotiation and review of regulatory documents for site activation and investigational product release.• Review and evaluate clinical trial data on an ongoing basis to ensure subject safety and protocol compliance; review and approve vendor and clinical trial site invoices.• Ensure clinical trials are complying with relevant procedures and industry guidance, e.g., Code of Federal Regulations (CFTs, International Conference of Harmonization (ICH) Guidelines, and Good Clinical Practices (GCP), and appropriate industry standards.• Develop scientifically rigorous clinical translational research strategies that assess mechanism, establish early signs of efficacy and drive combinations for oncology programs.• Analyze, interpret, and report results of clinical biomarker analyses, including support of regulatory filings; present work at local and national scientific congresses.

Conducted validation, qualification and stability studies to establish new clinical biomarkers tosupport Durvalumab (anti-PDL1 Ab) in clinical studies; performed clinical sample testing in GLPenvironment; and, prepared validation protocols, SOPs, and qualification reports.

• Established pharmacology laboratory to enable preclinical antibody drug development activities for oncology, cardiovascular, metabolic diseases, and innovative antibody therapeutics. • Research team lead on evaluation and selection of novel targets and novel disease indications.• Project team lead on multiple Ab project teams from target discovery to IND, evaluating Ab drug candidates in in vivo efficacy of oncology, cardiovascular and metabolic disease models in preparation for IND filing; and prepared study reports used to file IND.• Managed outsourced CRO studies and assumed leadership role in IHC endpoint analysis and quantification using definiens for all in house and clinical programs.• Conducted PK/PD studies to understand drug metabolism, target engagement and biomarker discovery and development for clinical translation. Well versed in cell-based approaches that include IHC, image analysis, FACs and plate and bead-based immunoassays.

Role of mitotic kinesins in breast cancer• Established six breast cancer sub-cutaneous xenograft models in-house with receptor positive and receptor negative background• Determined in vitro activity of the compounds using 2-dimentional and soft agar assays• Employed siRNA and shRNA to study the mechanism of action of novel targets• Demonstrated single agent activity of Ispinesib, a small molecule in various xenograft models • Performed combination studies with standard of care including antibodies and other small molecules• Evaluated PD markers to understand in vivo target modulation

Small molecule drug development for hematological malignancies• Primary pharmacology researcher for the pre-clinical in vivo evaluation of SNS-032 (BMS-387032), a small molecule CDK inhibitor currently in phase I clinical trials for hematological malignancies• Evaluated SNS-032 efficacy in various subcutaneous xenograft models• Evaluated in vivo sequence and schedule-dependency of SNS-032 in combination with standard chemotherapy agents in support of clinical development strategy• Performed PK studies by different routes, including SC, IV, IP and PO in support of Sunesis drug discovery projects• Evaluated relevant PD markers and assays for in vivo target modulation by Western Blotting• Implemented quantitative PCR to support biomarker validation• Collaborated with bioinformatics group to establish statistical parameters for interpretation of pharmacology data• Supervised and trained junior staff in performing in vivo procedures