Senior Clinical Studies Director
6 days ago
London
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to \nlife-changing medicines for people with serious diseases — often with limited or no \nWe have a diverse portfolio of marketed medicines, including leading \ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. \nOur patient-focused and science-driven approach powers pioneering research and development \nadvancements across our robust pipeline of innovative therapeutics in oncology and \nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development \nlaboratories, manufacturing facilities and employees in multiple countries committed to \nserving patients worldwide. The Senior Manager, Clinical Trial Study Start-Up is a subject matter expert in clinical study start-up and is responsible for leading process that enables planning, coordination, and execution of study, country and site-level start-up activities from site identification through to site activation. This role combines operational leadership with strong cross-functional collaboration, CRO oversight, and compliance with global regulatory and quality standards. \n The Senior Manager establishes SSU level objectives, delegates assignments appropriately, and regularly resolves a wide range of operational issues in creative and effective ways. This is the functional representative for SSU on the Clinical Trial Working Group (CTWG) for assigned trials \n Lead and manage end-to-end start-up activities for assigned clinical trials, including country/site activation strategies, country assessment and timeline input, regulatory submissions, essential document collection, and country and site readiness. \n Apply strategic insight and in-depth knowledge of start-up operations to identify and communicate risk to study, country or site start up, and implement solutions that align with broader clinical program goals. \n Oversee CRO performance for start-up activities and ensure compliance with timelines, budgets, metrics, and regulatory standards. \n Regularly interact with cross-functional peers and leadership, influencing decision-making and gaining alignment on complex or sensitive matters and building collaborative relationships. \n Provide expert input into budget planning, timelines, performance metrics, and resource recommendations for study start-up execution. \n Serve as a key contact point for country and site start-up progress, reporting regularly to CTWG and SSU leadership, including status updates, KPI tracking, risk mitigation, and issue resolution. \n Lead or contribute to functional initiatives that improve startup methodology, quality, tools, and process efficiency across programs. \n Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions. \n Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging . As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; Recognized as a subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways . \n Demonstrated experience establishing and managing work plans, performance metrics, and budgets for study start-up in both in-house and outsourced operating model. \n Proven ability to analyze complex issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings. \n Excellent communication, leadership, and stakeholder management skills. \n Experience supporting audits and regulatory inspections related to start-up activities. \n Bachelor’s degree in life sciences or related field; 5+ years of experience in operational clinical research, including 3+ years in study start-up operations and team leadership. \n\n#LI-Remote \n#Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. \n Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. \n The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.