• Serve as the CLIA Laboratory Director for Spear Bio’s high-complexity clinical laboratory. • Provide overall clinical, scientific, and regulatory oversight of CLIA-certified laboratory operations. • Ensure compliance with all applicable regulatory and accreditation requirements, including CLIA, CAP, and NY State CLEP, as applicable. • Oversee quality management program to ensure accurate, reliable, and timely laboratory testing. • Review and approve laboratory policies, procedures, test validations, and quality documentation. • Monitor laboratory performance and implement continuous quality improvement initiatives. • Provide clinical consultation to physicians and other healthcare providers regarding laboratory testing and test results. • Support laboratory readiness for regulatory inspections and accreditation surveys. • Foster a culture of quality, compliance, and scientific excellence.

Role Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Brazil Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions - Monitors trial participant safety - Participates in trial participant recruitment boost and retention activities - Presents on medical matters at kick-off and investigator meetings - Trains trial team in the therapeutic area and medical aspects of the protocol - Develops and reviews trial-specific documents within the scope of medical monitoring - Manages ongoing trial risks related to medical monitoring - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial - Reviews protocol deviations - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable - Prepares for and participates in trial audits, follows up on audit findings - Participates in feasibility assessment of potential and ongoing trials in the country/region - Participates in bid defense meetings and other interactions with clients - Acts as a medical expert and provides therapeutic expertise to other PSI departments Qualifications - Medical Doctor degree required - Experience as a practicing Gastroenterologist (minimum of 10 years) - Clinical Research experience preferred - Full working proficiency in English and Portuguese - Proficiency with MS Office applications - Communication, presentation and analytical skills - Problem-solving, team and detail-oriented Additional Information As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

• Recruit, develop, and lead the events execution team (meeting planners and event managers) to deliver consistent, high-quality conference and workshop experiences across the portfolio • Own day-to-day operational leadership for conference logistics, including F&B, room blocks, exhibit execution, and workshop delivery • Serve as the primary escalation point for onsite execution issues, coordinating across event managers, vendors, and conference leadership to resolve problems in real time • Drive execution planning and readiness across assigned conferences, ensuring milestones, dependencies, and vendor deliverables are tracked and met • Partner with VP Production on budget management, vendor performance, and continuous improvement of execution workflows • Provide execution insights, constraints, and opportunities to VP Production and conference product leadership to inform portfolio planning and sponsor feasibility • Ensure consistent execution standards across all events, mentoring team members on best practices, stakeholder management, and onsite leadership

Tiger Analytics is pioneering what AI and analytics can do to solve some of the toughest problems faced by organizations globally. We develop bespoke solutions powered by data and technology for several Fortune 100 companies. We have offices in multiple cities across the US, UK, India, and Singapore, and a substantial remote global workforce. If you are passionate about working on business problems that can be solved using structured and unstructured data on a large scale, Tiger Analytics would like to talk to you. Responsibilities**Program Leadership & Delivery: **Lead the end-to-end delivery of complex data and analytics programs. Own the roadmap, from problem definition and solution design to production-grade deployment. **Stakeholder Management: **Act as the primary point of contact for client VPs and Directors. Translate unstructured business problems into high-level analytics solution designs. **Global Team Management**: Lead and mentor a hybrid team of onshore (US) and offshore (Global Delivery Center) data scientists and data engineers. Ensure seamless collaboration across time zones. **Solution Architecture:** Work with technical leads to design of scalable AI/ML pipelines and data architectures. Ensure solutions adhere to enterprise standards and leverage modern technology stack **Domain Expertise:** Apply deep Medical device domain knowledge to validate model outputs and ensure they align with industry nuances **Commercial Impact:** Present analytical findings and quantify the business value and drive the operationalization of AI into business processes.