Insmed Incorporated

Compensation

Full 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 an Associate Director, Clinical Trial Operations on the Clinical Operations team to help us expand what's possible for patients with serious diseases. Reporting to the Sr Director, Clinical Trial Operations, you'll be responsible for the overall leadership, management, and oversight of phase I-IV clinical trials from protocol concept through CSR to ensure all study(s) are delivered on time, within budget, and with high quality data. You will lead the cross functional Clinical Study Team (CST), CRAs, CTAs, and the CRO to ensure execution of all operational aspects of clinical study(s) planning, implementation, data delivery and reporting. What You'll Do: In this role, you'll have the opportunity to provide leadership and management of a clinical study(s) and clinical operations aspects of a drug development program in compliance with GCP and relevant regulatory guidelines. You'll also: • Manage and oversee the operational aspects of Insmed's clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, clinical trial sites, etc • Lead CRO and other vendor selection and reviews contracts/work orders • Provide mentorship to assigned study staff (CTMs, CRAs and CTAs) or colleagues as assigned by the Senior Director Reviews metrics and Key Performance Indicators to ensure oversight of clinical trial progress • Participate in SOP and process development activities across Insmed functions. • Manages clinical study(s)/program budgets and execution study(s)/program timelines • Oversee the day to day of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and vendors • Be responsible for the creation and execution of site and team training plans. Plan and/or participate in investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meeting • Participate in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials • Present trial status and clinical operations strategy to project team and management. • Creates and/or reviews and approves specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, pharmacy manual • Approve action plans to address protocol compliance, safety, data, and administrative issues with investigational sites and CROs • Attend site visits to ensure oversight of CRO Who You Are: You have a Bachelor's degree along with 7+ years of experience in trial management with a sponsor company managing various phase clinical trials. You also have: • Experience in global clinical trial conduct in multiple phases of development across several therapeutic areas is required • Experience in financial management of clinical trials, including budgeting, forecast, accruals, invoicing, etc • Experience in CRO, vendor and laboratory selection, set-up, and management is required • Excellent communication skills (verbal and written) • Possess critical thinking skills for problem solving, conflict resolution, collaboration, interpretation and in leadership tasks • Highly organized with a strong attention to detail, clarity, accuracy, and conciseness • To exhibit Insmed's five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies Nice to have (but not required): • Experience in rare disease and/or orphan indications is preferred • Experience in the management across a development program and participation in NDA/sNDA filing is preferred Where You'll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements This position involves frequent domestic/international/global travel up to 25% #LI-JK #LI-Remote Pay Range: $164,000.00-213,000.00 Annual Life 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. Highlights of our U.S. offerings include: • Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) • Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration • 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance • Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities • Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back 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. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, 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 TotalRewards@insmed.com 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.