Description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we’re in. Are you?About the Role:We’re looking for a Director, Clinical Trial Operations EMEA on the Clinical Operations - Trial Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Sr. Director, Clinical Trial Operations, EMEA / APAC, you’ll be accountable for providing the leadership, strategic, operational planning and oversight of 1-2 indications within one compound to ensure all are delivered on time, within budget and with high quality. This role may manage clinical operations team members, as delegated by supervisor, to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Selected candidate will represent Clinical Operations in a range of cross-functional groups, global functional committee(s) and initiatives intended to enhance function and company efficiency and productivity, regionally, and globally. This is a remote role and can be located in the United Kingdom or in Switzerland.What You'll Do:In this role, you’ll have the opportunity to be the primary operational lead over an 1-2 indications within one compound, in collaboration with the Senior Director, Clinical Operations. Ensures consistent and successful execution of operational aspects of regional and global studies as appropriate, including timelines, budget, data delivery and reporting, vendor management, GCP, etc. You’ll also:<ul><li>Develop operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and other cross functional departments.</li><li>Ensure a “Quality Mindset” is in place across the organization by focusing on detailed plans to monitor the conduct of our studies, the management of our vendors and working closely with our QA organization to implement and manage a process for Inspection Readiness.</li><li>Contribute to the development and review of regional/global policies and procedures. Ensure compliance with all Company/Regulatory requirements & TMF quality standards.</li><li>Work with outsourcing/procurement management to optimize the vendor governance structure, incorporate performance metrics, and contribute to outsourcing discussions.</li><li>Provide leadership to Clinical Operations staff and to project teams for vendor evaluation, selection, management and quality-based oversight.</li><li>Assume responsibility for the management and leadership of the operations staff within the Clinical Operations group including recruitment, training, mentoring, career development, work assignments, performance evaluations and ongoing feedback to and of staff.</li><li>Benchmark, track and report operational and study metrics with the ability to digest complicated or complex issues and communicate program statuses in a concise fashion to an executive audience with the ability to identify critical path items and mitigation plans.</li><li>Have oversight of compound budget with the ability to manage variance to a minimal threshold. Ability to manage the accrual process as well as provide budget forecasting and scenario planning based on multiple study designs.</li><li>Posses ability to represent Clinical Operations in a professional manner to executive audiences including attendance at requested meetings (i.e., Global Clinical Team, Global Project Team, etc.)</li></ul>Who You Are:You have a Bachelor’s degree in the life sciences, healthcare, or related field, with an advanced degree preferred.You are or you also have:<ul><li>Minimum of 12+ years of progressive experience in a Clinical Operations role, and minimum of 7 years managing direct reports. Experience considered relevant includes clinical or basic research in a Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO).</li><li>Experience in rare disease and/or orphan indications is preferred & experience in conducting Gene Therapy studies required</li><li>Knowledge in all aspects of clinical operations, project management, the drug development process, and clinical trial conduct, including systems and procedures, as well as the regulations and requirements governing such conduct (including, but not limited to, ICH / GCP and regulatory requirements).</li><li>Experience managing staff and providing oversight of department activities</li><li>Ability to effectively oversee, manage, and influence CROs and third-party vendors to ensure successful execution of the studies, builds strong relationships to create strong alliances.</li><li>Ability to effectively negotiate and influence to solve high impact/scope problems and help resolve organizational problems.</li></ul>#LI-TB1#LI-RemoteLife at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Our offerings include:<ul><li>Flexible work schedules with purposeful in-person collaboration</li><li>Competitive retirement benefits, global equity awards, and participation in our Employee Stock Purchase Plan (ESPP)</li><li>Career development through the Insmed Learning Institute, external programs, LinkedIn Learning, and role-specific training</li><li>AI-powered and on-demand learning tools, including a digital assistant to help navigate internal resources</li><li>Hybrid-friendly technology and IT support for seamless teamwork across locations and time zones</li><li>Global recognition programs and Employee Resource Groups</li></ul>Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday.Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at <a target="_blank" href="mailto:TotalRewards@insmed.com">TotalRewards@insmed.com</a> and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Director, Clinical Trial Operations EMEA

Description

Insmed

Pipeline