Lead clinical and commercial supply strategy and operations.

Shaped growth strategy for a startup psychiatry practice, leveraging expertise in clinical operations management. Defined a path for scalability and designed core processes to drive profit and efficiency. Grew revenue by renegotiating insurance contracts, transitioning billing functions in-house, and shifting focus from rapid acquisitions to scalable operating processes. Oversaw daily operations across the practice including P&L management, billing, marketing, and personnel. Hired new talent for critical roles and created SOPs to streamline onboarding of new associates. Increased team capabilities through performance management and continuous feedback.

Directed clinical supply chain operations for Teva’s first generic / biosimilar therapeutic area, leading cross-functional study teams in driving operational excellence. Managed high-priority trials, monitoring, triaging, and addressing potential interdependencies and risks. Engineered processes for global sourcing and operations, including SOPs, risk mitigation, manufacturing controls, and IMP plans.Led global supply chain design and logistics pertaining to R&D clinical study design for global biosimilar programs. Defined study timelines, kit design, supply planning, vendor selection / management process, and compliance guidelines (ICH, GCP, GMP, GDP). Reduced clinical supply and risk by monitoring KPIs and implementing protocols for final drug release.

Oversaw clinical supply chain operations for drug research studies, ensuring timely and compliance provision of materials across transportation and distribution networks. Delivered study implementation plans for cost-effective and risk adjusted supply plan and updated them in accordance with real-time supply chain data. Built SOPs and risk protocols across the supply chain cycle. Supervised multimillion-dollar logistics budget. Sourced global vendors as primary contact for contracting, management, and supply chain. Monitored quality of vendor deliverables while meeting schedule, budget, and scope. Designed the Interactive Response Technology (IRT) platform with customized systems for study setup, maintenance, and testing.

Supervised clinical operations for global drug trials from Phase I through Phase IV, ensuring studies adhered to timelines, budgets, and ICH / GCP compliance. Created SOPs that aligned with operational plans for assigned studies. Responsible for vendor management and contracts, document reviews, close out activities, and integrity of trial data.

Led regional workstreams for global clinical trials in North America and Asia. Provided operational expertise, support, and oversight of CROs for studies across various phases and therapeutic areas. Ensured timely and accurate reporting of regional study data.

Served as primary point of contact for regional COMs / SACOMs, vendors, and functional team members in the clinical trial process. Led on-time execution of study deliverables including maintenance and close out of activities, regulatory and protocol documents, clinical input, SAE reports, data cleansing and analysis, budget analysis, and retrieval reports. Partnered with internal / external stakeholders to facilitate Phase III global oncology study, ensuring quality and consistency of research data from drug discovery and startup through database lock.