• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines. • Serves as study lead and primary contact for sponsors. • Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. • Generates and presents frequent study status updates and reports to sponsor. • Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates. • Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc. • Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. • Identifies issues and develops problem-solving strategies to ensure study timelines are met. • Prepares for and participates in third-party audits and FDA inspections.

• Supervises and supports the implementation of clinical initiatives and/or programs to enhance care coordination, operational efficiency, and quality outcomes • Oversees daily clinical operations and staff to ensure processes are executed consistently in alignment with NCQA standards, state regulations, and applicable contractual requirements • Coordinates and supports clinical, quality, documentation, and data submission activities to support operational and quality objectives • Reviews utilization, outcome, safety, and cost data and escalates identified trends or concerns to leadership for further action • Monitors individual and team performance metrics, identifies performance gaps, and provides coaching or escalates concerns to leadership as appropriate to support operational and quality goals

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 Senior Director, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Development Operations, you’ll provide strategic leadership and operational oversight for clinical trials across Insmed's development pipeline. This role is responsible for ensuring the successful planning and execution of clinical studies from protocol development through study closeout, while maintaining the highest standards of quality, compliance, and patient safety. This is a remote position. What You'll Do: In this role, you’ll have the opportunity to develop and implement clinical operations strategies, aligned with corporate objectives and Program goals. . You’ll also: - Provide functional subject matter expertise to the Global Program Team and develop clinical trial scenarios, options, timeline, and budget projections for decision-making. - Leverage broad clinical trial industry and biotech leadership experience to think beyond the clinical operations function and contribute to setting strategy for the Program, as requested. - Foster collaborative relationships with key external stakeholders, including clinical trial Investigators, Research Coordinators and Suppliers; Cultivate important relationships with key internal stakeholders, including Insmed senior management and cross-functional leadership. - Potentially serve on the Global Development Operations Leadership Team and contribute to setting Department strategy. - Ensure high-quality, consistent planning and execution of Phase I-IV clinical trials, including oversight of study feasibility, site selection, trial recruitment, data monitoring, study closeout, TMF, and study risk management. - Ensure compliance with GCP, FDA, EMA, and other regulatory requirements. - Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and other departments on the Global Clinical Team, responsible for delivery of trials within a Clinical Development Plan. - Partner with Procurement and Vendor Alliance Management to optimize external supplier performance, including establishing performance metrics, risk-sharing agreements, and partnership governance. - Benchmark, track, report, and evaluate operational and trial metrics, with the ability to interpret complex issues and communicate program status in a concise fashion to an executive audience. - Identify opportunities to improve the efficiency and/or effectiveness of clinical trial operations, develop strategies, make recommendations, and lead process improvement/enhancement initiatives. - Lead, coach, and develop a high-performing team of clinical operations professionals. - Manage resource allocation and capacity planning across multiple studies. - Foster a culture of quality, accountability, and patient-centricity. Who You Are: You have a Bachelors degree in life sciences, healthcare or a related field along with 12+ years of progressive clinical research/operations experience in the pharmaceutical/biotech industry and 5+ years in senior leadership roles managing clinical operations teams. You are or you also have: - Extensive experience across all phases of clinical research and across multiple therapeutic areas. - Robust knowledge of GCP, FDA regulations, and international regulatory requirements. - Proven track record of successful study execution and delivery in a fast-paced, dynamic environment. - Strong vendor management skills and CRO oversight experience. - Previous CRA/monitoring experience. - Experience in rare disease or respiratory therapeutic areas. - Experience with adaptive trial designs and innovative clinical trial methodologies. - Experience with regulatory submissions and Heath Authority inspections. Up to 25% domestic and international travel may be required for site visits, supplier meetings, and cross-functional/team collaboration. #LI-TB1 #LI-Remote Pay Range: $222,000.00-303,000.00 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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.

Alt Legal is a forward-thinking company changing how trademark professionals manage global intellectual property. Trusted by over 1,000 global law firms, IP boutiques, and Fortune 100 companies, our platform automates and simplifies IP management, helping legal professionals efficiently handle filings, manage deadlines, and identify infringement. Managing millions of filings, Alt Legal is recognized as one of the most respected trademark companies in the IP world. Our mission is to make trademark professionals’ lives easier through powerful automation, integrated tools, and exceptional customer service. Job Description We’re looking for a senior-level software engineer with deep backend expertise and solid front-end experience who can step in across the stack when needed. This is a hands-on role for someone ready to own architectural decisions, guide technical direction, and work directly with the CTO to elevate our engineering practices. You’ll collaborate with a mature engineering team, make key system-level decisions, and ensure our platform remains secure, scalable, and maintainable. This role is ideal for someone who wants to grow into a Tech Lead or Architect role while staying close to the code. Your specific responsibilities Design, build, and maintain scalable backend systems and APIs using Python (Django). Lead or contribute to architecture and technical design discussions. Collaborate with front-end engineers and occasionally implement or debug React-based features. Partner directly with the CTO to define technical standards, architecture, and development practices. Own and evolve the CI/CD pipeline, ensuring reliability and automation best practices. Write clean, maintainable, and well-tested code; perform thoughtful peer reviews. Mentor engineers and help establish engineering best practices across teams. Leverage AI-powered development tools (e.g., GitHub Copilot, Cursor, Cody) to accelerate delivery and improve efficiency. Model engineering excellence and support the growth of a high-performing engineering culture. Required Qualifications Preferred Qualifications Experience with Elasticsearch/OpenSearch (index design, query tuning, scaling). Familiarity with observability stacks and production logging/metrics/tracing best practices. Strong understanding of Azure infrastructure, networking, and cloud services. Familiarity with Metabase or other analytics/reporting tools. Exposure to AI agents, LLM-based systems, or intelligent automation frameworks. Prior experience as a Tech Lead, Staff Engineer, or Architect in a scaling organization. Knowledge of microservices, event-driven systems, or containerization (Docker, Kubernetes). Experience collaborating with distributed or outsourced teams. Strategic thinker – naturally researches options, considers trade-offs, and makes informed technical decisions. Action-oriented – bias toward shipping and iterating. Proactive – identifies problems and solutions before being asked. Collaborative – works well with our existing team and can help build culture. Growth-minded – excited about the opportunity to grow with the company. Quality-focused – balances speed with maintainable, scalable code. Persistent – doesn’t give up when faced with complex technical challenges. What We Offer Direct collaboration with the CTO on architecture, strategy, and delivery. High degree of ownership and autonomy in shaping our technical direction. A clear growth path toward Staff Engineer, Tech Lead, or Architect roles. Competitive compensation, flexible remote culture, and modern technology stack. Why Alt Legal Alt Legal is a customer-obsessed, forward-thinking company that believes great technology should simplify and empower. Our mission is to transform intellectual property management through intuitive automation and exceptional service. We’re proud to support over 1,000 global law firms and companies—and even more excited about the growth potential ahead of us. We’re a collaborative, kind, and diverse team that thrives in open, inclusive, and positive environments. We believe that a variety of perspectives leads to better ideas and stronger outcomes. Founded on the values of innovation, simplicity, and support, we ensure that every team member can grow while making meaningful contributions. Alt Legal is LGBTQ+ friendly, and we enthusiastically encourage individuals of all backgrounds to apply. How to Apply If you’re interested, you should submit your application via Breezy with a resume in PDF and a short statement explaining your specific interest in this role as well as why you'd like to join the Alt Legal team (2-3 sentences). If you have any technical materials (blog posts, articles, research papers, open source projects, etc.) that you’ve authored or created, we’d love to see some samples too. We will review applications on a rolling basis. Please note: We're not accepting solicitations from recruiters or agencies for this position. All candidates must apply directly.