Insmed Incorporated

Manage and oversee phase I-IV clinical trials, including vendor selection, budget, and team leadership, ensuring compliance and timely delivery. | 7+ years of trial management experience, global trial conduct, vendor management, and strong communication skills. | 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.

Lead and oversee clinical programs in ophthalmology, including strategy, data review, regulatory communication, and external stakeholder engagement. | MD or PhD with 10+ years in ophthalmology clinical development, experience with multiple phases of clinical research, knowledge of FDA and ICH-GCP guidelines, and management experience in biotech/pharma. | 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 four 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 Executive Medical Director of Ophthalmology, Clinical Development to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different diseases and supervise the clinical development team. This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, reviewing & interpreting clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data. This individual will play a crucial role in formulating the company’s ophthalmology pipeline and portfolio expansion, working closely with the research and commercial departments. What You'll Do In this role, you’ll have the opportunity to design and implement the clinical development strategy and clinical protocols while delivering high quality clinical programs, from first-in-human trials, through to full development. You’ll also: • Serve as the therapeutic area lead of the ophthalmology clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics. • Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies. • Perform medical monitoring, coding, and data cleaning, and prepare Investigator Alert letters and SAE reports in collaboration with Clinical Operations. • Ensure the medical integrity of clinical study reports and data interpretation/communication. • Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings including presentation at Advisory Committee Meetings. • Prepare safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team. • Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc. • Organize scientific advisory board meetings and data safety monitoring committee meetings. • Maintain a high level of clinical and scientific expertise in ophthalmologic disease area(s) by reviewing the literature and attending medical/scientific meetings. • Be an active participant with the gene therapy leadership team on the strategic direction of business and provide guidance on opportunities/hurdles that may be forecasted. Who You Are You have a professional level degree (OD, PhD) with an MD or DO preferred, along with 10 years of global experience in ophthalmology clinical development within the pharmaceutical/biotech industry. Additionally, you have: • Experience across multiple phases of clinical research (Phase 1-3). • Significant management experience in ophthalmology clinical development. • Pediatric experience preferred. • Gene Therapy experience preferred. • Clinical residency training in ophthalmology. • Experience with retinal diseases. • Knowledge of ICH-GCP and FDA regulatory guidelines. Where You’ll Work This can be a fully remote role because the selected candidate should be able to perform effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Alternatively, if you live within a drivable distance of our San Diego, CA or Bridgewater, NJ facilities, you’ll have the option to work remotely most of the time, but with more in-person collaboration when it matters most. Travel Requirements This role requires occasional domestic or international travel (approximately 20%). Pay Range $247,000.00-345,467.00 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.  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.

Lead and manage regulatory CMC submissions and strategies for drug products globally, collaborate with internal teams and external agencies, and mentor a team of CMC professionals. | PhD in relevant scientific field, 12+ years pharmaceutical CMC regulatory experience including 8+ years leadership, deep knowledge of global drug regulations, and strong communication and leadership skills. | Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science ’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science ’s Top Employers survey for four years in a row. A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2025, we became Great Place to Work-certified in the U.S. for the fifth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions within Insmed and with external CROs/CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends. Responsibilities • Plan, implement, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. • Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products. • Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for agency meetings. • Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities. • Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycle management. • Stay current with regulatory guidelines and industry standard methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. • Lead and mentor a team of CMC professionals, encouraging a collaborative and high-performance culture. Requirements: • Advanced degree (Ph.D. preferred) in a relevant scientific field (e.g., Chemistry, Chemical Engineering etc.). • 12+ years of experience in pharmaceutical development and regulatory CMC within multinational pharmaceutical and biopharmaceutical companies, and 8+ years in a leadership position. • Deep understanding of US, EU, and Japan regulations for drugs/biologics with the ability to identify the differences in regulations across the regions. Proven track record of close collaboration with Regulatory Agencies as the lead in agency interactions and product development meetings. • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support. • Extensive understanding of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development. • Ability to deal with issues of critical importance, provide regulatory strategy/advice, and make reasoned decisions on CMC regulatory issues for which there may not be clear or specific regulatory guidance. • Past experience conducting end-to-end project management tasks within CMC RA. • Active participation in Agency/Industry groups/forums expected. • Ability to read and collate scientific and medical literature. • Experience in drug substance and drug product development. • Strong communication skills with demonstrated ability to optimally present ideas and influence others to achieve desired results. • Ability to lead others without authority to move internal and external teams towards achieving goals that support Insmed’s key strategic objectives. • Flexible, diplomatic and able to nimbly deal with ambiguity. Must have a high degree of problem-solving proficiency and be adept at working across functions as a collaborative partner. • Highly organized with strong attention to detail, clarity, accuracy, and conciseness. Salary Range $247,000 - $345,467 a year Compensation & Benefits At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: • Flexible approach to how we work • Health benefits and time-off plans • Competitive compensation package, including bonus • Equity Awards (Long-Term Incentives) • Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here . Additional Information 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.