Role Description This is a policy and law reform role, not an operations or access role. The work is to change the rules — the federal policy and law governing clinical trials — so that more trials can be launched, run, and approved, faster and at lower cost. To be direct about scope: you will not be operating or running trials, and the role is not focused on trial access, diversity, inclusion, or equity. Those aims matter, but they are a different kind of work. This role exists to make trials themselves faster, cheaper, and more abundant to conduct — by reforming the system that governs them. This is a founding leadership role, working in close partnership with the initiative's Chief Science Officer to build the effort from the ground up. It runs on two horizons at once: - In the near term, you are the initiative's credible face in policy — the person who can sit across from a Senate HELP or House Energy & Commerce staffer, an FDA official, a hospital system's leadership, or a biotech CEO, and be taken seriously by all of them. - You help shape the legislative and regulatory reform agenda and drive it into the PDUFA 2027 window and its implementation. - Over the medium term, you build the field. There is no standing constituency for clinical trial abundance today; your job is to create one — a durable, formidable coalition of companies, investors, researchers, patient organizations, and policymakers who will carry this work long after any single legislative moment. Qualifications - Deep credibility in biotech, life sciences, or FDA / clinical-trial policy — this is a subject-matter role, not a generalist government-affairs one. - A track record of being taken seriously by senior, varied stakeholders: Hill offices, agencies, industry executives, investors, and researchers alike. - Evidence that you can build something durable, not only win a near-term legislative fight — coalition-building, institution-building, or genuine 0→1 experience. - Fluent in the case for reform that expands what's possible — cutting the friction, cost, and time between good science and the patients who need it. Requirements - Direct experience with PDUFA, user-fee reauthorizations, or FDA review-pathway reform. - Familiarity with international regulatory models (Australia, UK, EU). - An existing network spanning biotech, investors, research, and DC policy. Benefits - Competitive salary of 200000-250000 USD/year. - Private Health Insurance. - Paid Time Off. - Work From Home. - Training & Development.

• Support client engagements under direction of Senior Consultant • Form and restructure business entities • Prepare governance documents • Execute mergers and reorganizations for financial advisors • Prepare and assemble deliverables from templates • Coordinate meetings, filings, and timelines • Keep projects organized and follow through on details

• Facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements • Deliver site start-up and activation work to a high standard, working closely with your team and stakeholders • Assist in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions • Coordinate with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation • Maintain accurate and up-to-date records of regulatory submissions and approvals • Support study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures • Participate in study start-up meetings and provide input on regulatory requirements and timelines

• Understands customer needs and provides credit and lending-related sales and service to BMO customers or prospects • Advises customers on borrowing strategies and products that meet their objectives • Fulfills sales and service activities for the customer in accordance with approved procedures • Identifies and makes referrals to other business groups • Works through various channels based on the market needs to deliver the desired customer experience and achieve overall business objectives • Probes to understand customer needs and provides advice related to personal banking and borrowing strategies in the best interests of the customer • Manages all transactional outcomes of customer contacts or defers to appropriate internal business groups • Escalates complex or unresolved customer situations to managers as required • Performs any required documentation to ensure customer’s requests are accurately processed • Maintains current knowledge of personal banking and lending products, practices, and trends and integrates into customer conversations in a professional manner • May research and investigate lending applications, following established processes • Handles customer contacts in an informed, professional, and efficient manner • Integrates marketing promotions and programs into customer conversations, where appropriate • Maintains the confidentiality of customer and Bank information • Identifies and reports suspicious patterns of activity that are suspected to be related to money laundering • Adheres to regulatory and compliance requirements, including Anti-Money Laundering and Terrorist Financing reporting requirements, Financial Consumer Agency of Canada (FCAC) consumer provision requirements and Privacy Act provisions • Makes credit decisions / recommendations in accordance with sound credit-granting principles and in compliance with Bank Policy & Procedures • Uses authorized credit qualifications as needed to fulfill customer requests • Completes complex & diverse tasks within given rules/limits • Analyzes issues and determines next steps; escalates as required