Functional Skills
Software Skills
Sector Experience
Experience
• Held the roles of Program Team Leader, Development PM and CMC PM to strategically advance CAR-T cell flagship programs, aligning deliverables with corporate goals & product strategy documents, e.g., Target Product Profiles (TPPs), integrated Product Development Plans (iPDP), Risk Management Plan (RMP), Program Team Charter, others, and contributing to the company’s transition from research to clinical development
• Served as a trusted strategic partner to the CEO, CMO and the Executive Leadership Team, helping to address problems and identify solutions
• Enabled strategic decision-making and portfolio prioritization efforts, driving improved operational efficiency and business performance across a nearly $1B R&D pipeline
• Maintained a productive collaboration with Regeneron
• Enhanced processes to improve cross-functional collaboration, data-driven decision-making and risk management
• Continued accountability for program oversight of and execution support for the NKTR-262 Phase 1 / 2 program
o Collaborated closely with Clinical, Regulatory and Quality to execute a global Phase 3 registration study, an EMA MAA filing, an EMA GCP inspection readiness plan, and pediatric development plans for the first oncology product, Onzeald, etirinotecan pegol or NKTR-102, a long-acting topoisomerase-I inhibitor, in metastatic breast cancer patients with brain metastases (BCBM)
o Partnered closely with Clinical to drive the execution of multiple early stage bempeg clinical studies
o Demonstrated strong PM oversight of and execution support for the Toll-like receptor (TLR) 7 / 8 agonist product, NKTR-262, from candidate declaration and IND filing to Phase 1/2 execution
o Supported biomarker-informed development strategies for NKTR-102 and NKTR-262
• Established a productive collaboration with Onzeald commercial partner, Daiichi Sankyo Europe, enabling productive relationship
• Acted as the primary contact for collaborations with NCI-CTEP, SWOG, FNIH, and study investigators, enhancing execution of collaboration trials and strategic decision-making
• Served as a resource for clinical, safety and scientific issues raised by internal and partnered colleagues
• Supported the development of clinical trial publications and presentations in collaboration with Medical Affairs
• Developed and deployed performance monitoring tools / practices and trained teams to ensure operational excellence
• Developed and maintained the annual operating plan budget in alignment with Finance and the R&D Functions
• Mentored and developed PM and administrative direct reports
• Delivered PM excellence for multiple global registration-enabling and -supportive trials (two Ph 3 in multiple myeloma, two Ph 1/2 in SCLC, a pediatric ALL trial, two China Ph 3 CTAs in multiple myeloma, and a Ph 3 minimal residual disease (MRD) trial in multiple myeloma) by aligning cross-functional teams, managing deliverables per plans, mitigating risk, communicating strategically, promoting effective decision-making and having productive interactions with external partners
• Standardized processes and timelines for enhanced operational efficiency across the R&D organization
• Partnered with Alliance Management to establish effective joint governance committees (marketing, development, research, patent), ensuring timely joint decision making and streamlined operations for collaboration trials between Onyx and Bayer
• Developed and maintained the annual operating plan budget, ensuring accurate forecasting and resource alignment across multiple clinical programs in collaboration with Finance and R&D Functions