Shirley Poon M.S., M.B.A., Pharm.D.

Lead global and US primary market research across multiple brands (Blincyto, Kyprolis, Nplate, Xgeva, Otezla, Tez/Teze), spanning HCP and patient/consumer audiences; translate Brand Team needs into an annual insight generation plan with clear decisions, hypotheses, and learning priorities. Drive end-to-end research execution (study design, vendor selection/management, instrument development, fieldwork oversight, analysis, synthesis) to deliver executive-ready insights that inform strategy, positioning, segmentation, messaging, and GTM choices. Provide decision support for Executive Reviews, Brand Planning, budgeting, and business cases, ensuring recommendations are evidence-based, stakeholder-aligned, and tied to measurable KPIs. Convert research outputs into actionable implications (what/so-what/now-what), influencing cross-functional teams and accelerating decision-making under time constraints. Build team capability by implementing standard methodologies, templates, and tools (internal/external) to improve quality, consistency, and speed-to-insight.

Lead a team of 7 global clinical managers and 5 regional managers and aligning 20+ stakeholders in other departments in Acapatamab (AMG 160) Accomplished Innovative Study Design clinical trial executing > 250+ subjects in an early development registrational trial Leads the Program level planning of the overall operational deliverables at the Evidence Generating Team meetings Develop the strategic scenarios on the designs of the clinical development plan as part of the EGP generation Drives the Operational Strategy of the Molecule Develop and author the clinical protocol, Informed Consent Forms, patient and physician facing material Review of study related documentation, Clinical Study Report, Investigator Brochure, Publications Generate, oversee, and update study budgets and timelines. Evaluating the feasibility of the program strategy and amending study timelines, as appropriate. Identify, and perform feasibility for the selection of early phase clinical investigators Organize investigator and site meetings, initiating early engagement with key thought leaders Ensure all site and study team members receive adequate training to conduct early development studies Oversight in the preparation of site initiation regulatory documents, approve site visit report and provide overall management of study related activities Lead the Dose Level Review meetings

Support development and regular review of Investigational Product Instruction Manual (IPIM) template and associated documents on cutting edge and innovative products on the market. (i.e. Inflammatory and Oncology products) Provide input and support into the design of IP sections of study protocols. Effectively communicating orally and through writing to explain policies and procedures as well as persuade others to adopt a specific opinion or action. Provide concise and coherent input and feedback on drug packaging and labelling proposals for clinical studies Developed and implemented of preventive actions and process improvement initiatives related to Investigational Product (IP) Management Support internal stakeholders & networks to promote greater cross functional understanding and insight into clinical IP needs, IP presentation and preparation challenges Identify and support site challenges related to the clinical preparation, labeling, packaging and administration of IP and bring these issues to the appropriate team(s) within Sponsor for analysis and mitigation Investigate potential IP risks identified at clinical sites and assist CRA/study teams with resolution and action plans Pro-actively explore dosing deviation trends and root causes to identify risk indicators and mitigation plans Act as the primary point of contact for study related IP Management questions Understand the capabilities of the clinical sites to inform internal testing of representative materials and delivery approaches Collaborate with and support GDO stakeholders and leadership in responding to IP related audit/inspection queries Provision of subject matter expert input and support into organizational process improvement initiatives Developed collaborative website (Sharepoint) for external stakeholders to input product specific libraries to author SMART IP Instruction Manual for clinical studies.

More than doubled the revenue and bottom line within 3 years of owning the store implementing policies and procedures for the store to follow-through with patient expectations and expanding pharmacy services. Compounded clinical trial IP per Investigational Sponsored Studies approved by IRB institution. Developed clinical research contracts and grew business platform for acquiring new revenue streams. Developed process and procedures for analyzing packing statistics, internal and external QA, controls for blinding studies, and packaging IP. Designed and remodeled compounding lab with appropriate laboratory equipment and established new guidelines for quality assurance in accordance to USP 800 Medication Management: Devised and recommended writing patient prescription orders for Hormone Replacement Therapy to physicians, resolve any DDI, duplication of therapy, adherence, and missing medications that would optimize therapy. Train and Manage employees and their payroll, hiring, and screening Marketing to local doctors and creating marketing plans for assisted living homes. Implement new policies and procedures for new services such as birth control, travel clinic, immunization, compounding, and sync program. Establishing and managing new relationships with vendors, patients, and physicians Ability to satisfy customers and respond to changing priorities and deadlines, despite frequent interruptions high volume store. Apply tact and discretion toward patients and visitors with health concerns through listening perceptively and responding appropriately. Optimizing workflow to enhance efficiency of the pharmacy through operation and inventory management. Outreach to community giving educational seminars to patients Establish position contracts for each employee as well as quarterly goals and performance evaluations. Compound expert in hazardous, non-sterile products ranging from creams, ointments, suppositories, capsules, and troches.

Daily clinical monitoring and adjustment of TPNs through collaboration with the nutritionist to optimize therapy for critical adult and pediatric patients. (~10-15 patient/day) Compressing TPNs for patient discharge and home infusion. Monitor and calculate pharmacokinetics of antibiotics and renal dosing of antibiotics when appropriate for age specific and disease specific (~50-60 pts/day) Clinical recommendations of adjustments to physicians made based on EPIC laboratory findings and dose level concentrations. Clinical evaluation and preparation of adult and pediatric chemotherapy. (5-10 pts/day) Used evidence-based medicine to review and confirm physician written chemotherapy regimen adheres to documented research literature. IVIG, Factor IX, and Factor VIII preparation. Dispensed patient cassettes, crash carts, occasional compounding, and narcotic pyxis refills. Participation in Code Blue. Provision of drug information, DDI, and daily clinical interventions using therapeutic substitutions on formulary. Compound IV admixtures and other sterile products such as IT injections with aseptic technique including chemotherapy. EPIC EMR utilization to help interpret laboratory, clinical data and physician recommendations to authorize orders.

* Wrote and substantively edited strategic INDs and NDAs (ie. Rozerem (Ramelteon)) for submission to the FDA. * Compiled and ensured adherence to ICH CTD guidelines for non-clinical and clinical pharmacology, toxicology, and pharmacokinetic data. * Collaborated with Regulatory, Marketing, and Biostatistics departments, coordinated reviews and approval, collated reviewers’ comments, and prepared final NDA and IND submissions. * Coordinated contributions from external contractors and facilitated writing activities with external authors, including investigators and project managers. * Evaluated safety issues tested in humans i.e. mutagenicity, carcinogenicity, reproductive and developmental toxicity.

Dispense, compound IV and oral solutions, procure, distribute, store, and unit dose medication into Pyxis and individual patient cassettes. Pharmacokinetic antibiotic and anticoagulant (warfarin and heparin) monitoring. •Provide medical personnel and patients with medication information and product identification. Assess patient profiles to evaluate accuracy and to reconcile any medication order discrepancies.

Developed soft skills and business perspective on large organizations.

Learned how to be a worldclass clinical pharmacist

Developed a deep understanding of drug delivery and drug discovery process