Insmed

Title: Senior Counsel, Biologics Intellectual Property Location: United States Hybrid NJ Corporate Headquarters Full time job requisition id R3596 Job 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 are seeking an accomplished and highly strategic patent attorney to lead the strategy for our biologics patent portfolio. This role is designed for a senior expert who can operate at the intersection of sophisticated patent prosecution, patent disputes and competitive intelligence gathering. Reporting to the Chief IP Counsel, this individual will serve as our patent portfolio lead for all biologic programs within Insmed, with responsibility for developing and integrating global prosecution and challenge (both offensive and defensive) strategies. The role will function as a key strategic partner to the Chief IP Counsel, with a primary focus on strengthening the durability and value of Insmed's biologic assets worldwide, anticipating competitive threats, and identifying and mitigating vulnerabilities. The Sr. Counsel will work closely with research, CMC, development and broader product teams to harvest new inventions, draft patent applications, provide direction on prosecution strategy, and to perform IP due diligence activities. This position may include management responsibility for members of the IP team, such as those handling patent prosecution. The role is based in Bridgewater, NJ or San Diego, CA with a hybrid work model (onsite 3+ days per week). What You'll Do: In this role, you will lead end-to-end IP strategy for our biologic patent portfolio, carefully integrating global prosecution and third-party considerations into a cohesive and forward-looking approach to maximize exclusivity positions. You will also have responsibility for: - Provide legal advice to cross-functional R&D and business teams on a variety of IP-related matters. - Draft, file, and prosecute strategic patent applications worldwide both directly and through management of outside counsel and in house IP team. - Play a central role in third-party challenges and challenge preparation, both offensively and defensively, while coordinating with outside counsel, including European oppositions and appeals, US post-grant proceedings (IPRs, PGRs), and litigation (e.g., US, Europe, China). - Partner with the Chief IP Counsel on broader portfolio-level prioritization and risk assessment, while maintaining primary ownership of patent strategy. - Drive competitor intelligence efforts and freedom-to-operate analyses, translating insights into actionable IP strategies. - Identify gaps, risks, and whitespace opportunities across research and development programs, and ensure coordinated coverage and prosecution. - Collaborate closely with internal subject matter leads and, where appropriate, provide mentorship or direct management to team members aligned with patent workstreams. - Review manuscripts, presentations, press releases, corporate disclosures and other publication materials for clearance. - Support business development, due diligence, and executive-level discussions as a subject matter expert in asset IP. - Manage and direct outside counsel globally to efficiently deliver high-quality, strategically aligned work product. Who You Are: You hold a Ph.D. in a life science discipline in addition to a J.D. from an accredited US law school and member in good standing of a US State Bar. You will have15+ years of patent experience in the pharmaceutical/biotech sector, with significant in-house experience within a pharmaceutical/biotech company. In addition you will have: - Deep and creative expertise in biologic patent prosecution, including viral gene therapy, protein biologics and antisense oligonucleotide technologies. - Significant experience with patent disputes, including oppositions, IPRs/PGRs, and/or litigation. - Demonstrated ability to integrate prosecution and dispute strategies into a cohesive, forward-looking IP approach. - Strong understanding of global patent systems. - Demonstrated successful experience advising senior management on complex IP issues, including risk assessment and strategic decision-making. - Ability to operate as a senior individual contributor and strategic leader, with or without formal people management responsibilities. - Superb technical, written and verbal communication skills in English. - Ability to write well as evidenced by past patent applications and USPTO responses. - Individual must possess initiative, high emotional intelligence and have strong interpersonal skills. - Registered to practice before the US Patent and Trademark Office. Where You'll Work This is a hybrid role based either out of our Bridgewater, NJ or San Diego, CA office. You'll work remotely most of the time, with in-person collaboration when it matters most. #LI-SK1 #LI-SK - Hybrid Pay Range: $247,000.00-337,500.00 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. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: - A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or - An alternative selection process by emailing Privacy@insmed.com. - Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.

Role Description We’re looking for a Senior Associate, Clinical Trial Operations on the Clinical Operations - Gene Therapy Team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Clinical Operations - Gene Therapy, you’ll assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc. In this role, you’ll have the opportunity to work with global cross‐functional teams to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines, government regulations, etc. - Support Clinical Operations through study start-up, patient recruitment, maintenance, and study closure activities. - Coordinate the creation and distribution of study materials, including essential documents, presentations, and reports. - Lead site and sponsor training tracking, maintain training matrices, and assign study-specific plans via Insmed's Learning Management System (LMS). - Track essential study milestones and maintain study trackers (e.g., team roster) to support study oversight. - Facilitate logistics for Investigator Meetings held by third-party vendors in collaboration with Insmed. - Serve as the point of contact and liaison for the Medical Review Committee (MRC) on site/patient-facing materials. - Drive clinical study team and vendor meetings by scheduling, drafting agendas, capturing action items, and documenting decisions. - Review and submit CRO/vendor contractual documents, work orders, change orders, and amendments into Procurement and legal approval systems. - Assess CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials. - Partner with Quality Assurance to support audits, inspections, and regulatory body inspection readiness, including document retrieval and CTA inspection readiness checks from startup through closeout. - Process clinical trial invoices and liaise with Finance to create purchase orders and requisitions via the Procurement system. - Mentor and train CTAs as appropriate. - Maintain the Trial Master File (TMF), lead periodic TMF QC checks, and oversee Sponsor- and CRO-supported TMF quality activities per ICH/GCP requirements. - Report TMF metrics, identify risks and trends, and follow up with CROs and functional area representatives on outstanding issues. - Conduct monitoring, co-monitoring, and oversight monitoring activities to support ongoing clinical trial oversight. Qualifications - Minimum Bachelor's degree in healthcare, life sciences or a related field. - 3+ years of progressive experience in a Clinical Operations role on the sponsor side or 5+ years at a CRO. - Demonstrated hands-on monitoring experience. - Solid understanding of clinical research processes, including all functional areas of clinical trials, medical terminology, and FDA/local regulatory requirements. - Ability to apply proven knowledge of budgetary and financial practices, including budget review and forecasting, purchase order management, and payment tracking for external parties. - Extensive experience with Trial Master Files (TMF), both paper and electronic (eTMF), including Veeva, with a strong understanding of the DIA TMF Reference Model. - Experience executing study start-up activities with confidence, including feasibility assessments, country and site activation, and patient recruitment efforts. - Able to collaborate effectively with CROs and third-party vendors to ensure quality study execution and build strong, productive team alliances. - Ability to coordinate seamlessly with global cross-functional team members to plan and execute study activities across all regions. - Ability to communicate clearly and effectively — both verbally and in writing — while demonstrating strong conflict management skills and a high level of organization, attention to detail, and accuracy. Requirements - Nice to have (but not required): Experience in rare disease and/or orphan indications is preferred. - Demonstrated ability to train and mentor new hires and colleagues, as needed. Benefits - 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.

Role Description We’re looking for a Pharmaceutical Case Manager on the Patient Services team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Case Management, you’ll oversee the patient journey from initial onboarding through ongoing support and service, ensuring a positive and seamless experience for patients in your designated region. Case Managers will be an integral part of a collaborative team focused on delivering exceptional support to patients in need of specialty medications. In this role, you’ll be responsible for building strong relationships with internal stakeholders, as well as patients and healthcare professionals, ensuring timely delivery of services while exhibiting Insmed’s core values of Compassion, Accountability, Passion, Respect and Integrity. You’ll also: - Patient Support & Case Management: Manage the patient journey, from initial prescription receipt through ongoing treatment support, ensuring timely and accurate services are provided. - Collaboration with Cross-Functional Teams: Partner with team members across departments to troubleshoot issues, share best practices, and ensure a holistic and patient-centric approach to care. - Prior Authorization & Insurance Coordination: Verify insurance coverage and prior authorization status, and help resolve any barriers to treatment; as well as collaboration with the Field Access Manager and Key Account Directors to monitor access challenges. - Therapy Initiation Coordination: Ensure that all aspects of the patient’s therapy initiation experience are well-coordinated, including the ability to support patient questions in accordance with prescribing information (PI) data as indicated. - Ongoing Outreach: Provide continuous education based on the prescribing information (PI), monitor patient progress, and address any concerns to ensure adherence to the prescribed treatment plan. - Utilize motivational interviewing communication techniques to deliver appropriate communication and engagement based on patient needs. Qualifications - Bachelor’s degree or equivalent experience. - 2 years of experience in Case Management within pharma/biotech, clinics, hospital or insurance company. - Superior Interpersonal Skills Acumen. - Open Minded & Adaptable. - Patient-Centric Approach. - Dedicated. - Expert Communicator. - Proactive Problem Solver. - Working knowledge and experience with health insurance, Medicare Part D coverage, prior authorization process, and Rx reimbursement, specifically in specialty drugs. - Understanding of HIPAA and privacy laws and requirements. - Experience with Adverse Event and Product Quality Complaint reporting. Requirements - 1 year in pharmaceutical or biotech case management (nice to have but not required). Benefits - 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. - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP). - 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.

Role Description We’re looking for a Senior Director, Clinical Development on the Clinical Development team to help us expand what’s possible for patients with serious diseases. You’ll serve as a clinical leader responsible for supporting two primary activities: - Clinical evaluation of potential in-licensing or acquisition opportunities coordinated and led by Insmed’s Business Development organization. - Support cross-functional discussions with Insmed discovery research platforms as molecules advance beyond the Late Lead Optimization milestone. In this role, you’ll have the opportunity to provide clinical input into the overall assessment of external molecules as a member of Due Diligence teams. You’ll also: - Contribute clinical input to cross-functional planning for molecules emerging from Insmed discovery platforms at the Late Lead Optimization stage. - Serve, as needed, on transition teams for molecules that are in-licensed, acquired, or partnered. - Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas. - Partner with Global Clinical Development functions to monitor benefit–risk profiles, manage safety signals, and support regulatory communications or meetings for any ongoing studies associated with in-licensed or acquired assets that are in transition to early GPT or GPT formation. - Collaborate with Global Clinical Development functions to support the design of potential clinical studies and Clinical Development Plans (CDPs) that meet global ICH-GCP, ethical, and regulatory standards. - Build and maintain strong partnerships with external medical experts supporting development programs for in-licensed or acquired assets that are in transition to early GPT or GPT formation, as well as emerging programs from Insmed discovery platforms. Qualifications - MD, MD/PhD, or equivalent medical training is required. - Board certification in an internal medicine specialty that includes immunological disorders such as Rheumatology or Transplantation. - At least 7 years of clinical development experience in biotech or pharmaceutical settings. - Meaningful drug development experience across modalities, including oral small molecules and biologics; experience with combination drug–device products preferred. - Original NDA, MAA, and J-NDA experience is a plus. Requirements - Demonstrated leadership in the design, execution, and interpretation of global Phase 1–2a clinical programs; experience with combination drug–device development and later-stage programs is a plus. - Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA. - Proven ability to lead and influence effectively within cross-functional, matrixed organizations. - Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders. - Strategic thinking and sound clinical judgment. - High scientific and analytical rigor. - Strong influence and decision-making skills in matrixed environments. - Excellence in communication and external engagement. - Ability to navigate ambiguity and make timely, balanced decisions. - Effective collaboration across global, cross-functional teams. Benefits - 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. - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP). - 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. Company 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?

Role Description We’re looking for a Senior Director, Channel Account Management on the Commercial Operations & Channel Management team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Head of Channel, Distribution and Access Programs, you’ll have responsibility for leading Insmed's specialty pharmacy account management function, driving contracting excellence, and leveraging data insights to optimize patient access and operational performance. This role serves as the primary strategic owner of specialty pharmacy relationships and works cross-functionally with Market Access, Legal, Compliance, and Product Teams to deliver channel solutions aligned with business objectives. What You'll Do: - Lead a team of Channel Account Directors, establishing clear goals, strategic roadmaps, and performance expectations across limited specialty pharmacy networks. - Oversee strategic management of specialty pharmacy programs, including onboarding, performance tracking, and service delivery. - Assess, design, and implement enhanced pharmacy services to improve patient experience and access. - Represent Insmed at national industry meetings and translate market insights into actionable internal recommendations. - Lead contract negotiation strategy with specialty pharmacy partners, including development of coordinating business rules. - Develop and manage network strategy, including partner prioritization, access optimization, and channel readiness planning for current and pipeline products. - Assume oversight of enhanced service agreements, ensuring compliance with all legal, regulatory, and corporate policies. - Manage the gross-to-net (GTN) financial impact of pharmacy services and ensure alignment with business objectives. - Drive pharmacy channel business reviews, setting and tracking performance goals across the network. - Leverage HUB and specialty pharmacy data to monitor the patient journey, track new patient starts, and surface actionable access insights. - Apply analytical rigor to identify trends, evaluate outcomes, and continuously improve channel and access performance. Qualifications - Bachelor's degree with an MBA or advanced degree preferred. - 12+ years of pharmaceutical/biotech trade or channel experience, with deep specialty pharmacy expertise. - Proven specialty pharmacy contracting experience, including negotiating and operationalizing enhanced service agreements. - 5-7 years of people leadership experience. - Strong financial and business acumen with demonstrated ability to manage GTN and channel economics. - Proficiency in interpreting specialty pharmacy, claims, and HUB data to drive informed decision-making. - Commercialization and launch experience in rare disease or specialty therapeutic areas, including channel readiness planning. - Demonstrated leadership in managing cross-functional teams and influencing senior stakeholders. - Deep knowledge of specialty pharmacy operations, network dynamics, and patient access pathways. - Skilled in structuring, negotiating, and operationalizing complex pharmacy agreements. - Translates complex market access and pharmacy data into strategic action. - Anticipates market shifts and defines long-term channel strategies. Benefits - 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. - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP). - 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.

Role Description We’re looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you’ll have a critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs and market. Under the guidance of the Associate Director, you will ensure high-quality, timely, and compliant preparation and delivery of regulatory documentation throughout product lifecycles. You will work closely with Regulatory Strategists bridging regulatory strategy and operational execution, while supporting cross-functional teams to ensure alignment with global regulatory requirements and internal standards. What You'll Do: - Support aspects of tactical implementation for assigned projects including project timeline planning and documentation workflow management for global regulatory documents (including but not limited to INDs/CTAs, NDA/BLAs, MAA, amendments annual reports) in alignment with established timelines, regulatory requirements, and internal quality standards. - Author and oversee the preparation of regulatory documents and meeting materials (e.g., meeting requests, briefing books, cover letter forms, etc.) ensuring clarity, accuracy, and consistency. - Lead document workflows throughout document lifecycles for regulatory documents, including creation, review, approval, revision, distribution, and archival. - Assist in preparing and organizing all comments received from regulatory agencies and manage and/or track the company’s planned response. - Partner with Regulatory Strategies and act as a point of contact for cross-functional teams (e.g., Clinical, Nonclinical, CMC) to ensure effective coordination and execution of regulatory deliverables. - Monitor new regulations and guidelines to ensure internal processes and deliverables remain compliant. - Contribute to the development and improvement of regulatory systems, tools, and procedures to enhance efficiency and quality. - Maintain submissions and correspondence and archive regulatory files using Veeva Vault Document Management System. Qualifications - Bachelor’s degree along with 5+ years of experience in Regulatory Affairs in the pharmaceutical or biotechnology industry. - Excellent organizational and time management skills to manage multiple ongoing projects simultaneously to meet tight deadlines. - Knowledge and understanding of regulations and guidances. - Excellent communications skills (written and verbal). - Efficient, detail-oriented, flexible, and a self-starter. - Able to work in different document repository and sharing database. - Proficient in MS Office applications (Word, Excel, PowerPoint, Outlook), Adobe Acrobat. Requirements - Preferred experience in SmartSheet or other project management software. Benefits - 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. Travel Requirements - This role requires occasional domestic/international travel (approximately 15%).

Role Description We’re looking for a Manager, Manufacturing Science & Technology on the Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Manufacturing Sciences & Technology, you’ll be responsible for playing a critical role in bringing rAAV-based therapies to market by closely supporting our external manufacturing partners. You will serve as a critical technical bridge between Process Development, CMC, and GMP manufacturing, ensuring process robustness, seamless technology transfer, and sustained manufacturing excellence across development and commercial stages. The ideal candidate will possess a good understanding of state-of-the-art AAV manufacturing knowledge, including suspension HEK293 cell culture and ultracentrifugation-based separation processes, as well as exposure to gene therapy regulatory requirements across early and late phases. What You'll Do - Lead and execute end-to-end technology transfer activities from process development through commercial-scale GMP manufacturing, including facility fit assessments and coordination of process start-up activities. - Review critical documentation, including both pre- and post-execution batch records, SOPs, raw material specifications, development reports, and GMP protocols. - Serve as a person-in-plant during production campaigns, providing real-time support and ensuring alignment with established process parameters and quality standards. - Perform active process monitoring and data trending, and assist in process improvements for the manufacture of Drug Substance and Drug Product. - Drive timely closure of process deviations in Veeva by partnering with cross-functional teams, leveraging expertise in document management systems to ensure compliance and traceability. - Support change control management for process versions and process comparability assessments. - Assist with planning and execution for process characterization and Process Performance Qualification (PPQ) activities. - Provide broad technical support across MSAT initiatives as needed, such as assistance with Statement of Work (SOW) review and submission, and contribute to supply chain risk mitigation efforts. Qualifications - Bachelor’s degree along with 5 years of relevant experience in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or a related field. - Solid technical background in drug substance (upstream cell culture, downstream purification) and/or drug product operations. - Hands-on experience interacting with GMP manufacturing, process validation, and tech transfer teams. - Ability to work in a fast-paced and dynamic environment. - Ability to work independently, remote from central leadership. - Strong interpersonal skills and the ability to work in a fast-paced, multidisciplinary environment. - Strong verbal and written communication skills are essential. Nice to have (but not required) - Expertise of drug product fill process is a plus. 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. Candidates located on the East Coast — particularly in Ohio, Massachusetts, and Rhode Island — are strongly encouraged to apply. Travel Requirements This position involves frequent global travel (up to 40%) for visits to our CDMO sites. Pay Range $127,000.00-165,500.00 Annual Benefits - 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.

Role Description We are seeking an Associate Director, Marketing – Disease Education & Integrated Marketing to join our dynamic marketing team. Reporting to the Global Commercial Lead, this role will combine strategic ownership with hands-on execution across two critical areas: - Leading a field-based disease education program - Executing integrated marketing initiatives for healthcare professional and patient audiences This is a highly execution-oriented role designed for a well-rounded marketer who can move seamlessly from strategy to on-the-ground delivery. This individual will play an important role in supporting earlier disease recognition and diagnosis while driving measurable commercial outcomes across HCP and patient-facing programs. What You'll Do - Field-based Disease Education Program Leadership - Lead the operating model, execution, and ongoing evolution of the field-based disease education program - Oversee the external partner responsible for program staffing, training, field execution, performance management, and measures of success - Ensure field personnel have the resources, capabilities, and support required to deliver high-quality, compliant disease education - Monitor program performance, identify opportunities and barriers, and implement improvements to increase effectiveness and impact - Drive measurable growth in diagnosed patients by increasing clinical suspicion and appropriate screening across priority HCP segments - Integrated Marketing Activation - Lead the development and execution of integrated marketing initiatives for HCPs and patient audiences, translating established strategies and customer insights into impactful programs and experiences - Develop and deliver HCP engagement programs that support disease education, including speaker programs, peer-to-peer education, and congress excellence - Oversee patient-facing educational resources and manage across a range of channels, including social media, website, and other engagement platforms to drive awareness and action - Lead agency and external partner relationships, providing clear direction and ensuring high-quality, timely, and compliant execution - Cross-Functional Partnership and Program Oversight - Partner with core marketing and a broad range of cross-functional stakeholders – including Medical, Regulatory, Legal, and Analytics – to ensure the timely, compliant in-market activation of marketing initiatives - Oversee program execution and ongoing management with a strong commercial mindset, communicating progress, performance, recommendations, and decisions clearly to senior leaders and cross-functional stakeholders Qualifications - Bachelor's Degree - 8+ years of progressive pharmaceutical commercial experience (marketing) - Respiratory or rare disease experience preferred - Demonstrated experience developing and executing integrated marketing programs for HCPs and/or patient audiences - Experience leading field-based programs, vendors, and external contractors - Strong analytical thinker who uses data and insights to drive decisions and optimize performance - Strong executional discipline with ability to manage multiple priorities in a fast-paced environment - Skilled business storyteller with the ability to connect insights to outcomes Requirements - This is a fully remote role that can be performed effectively from anywhere while staying connected to your Insmed team and community - Occasional travel for team meetings, congresses, or field events will be expected - This role requires occasional domestic travel, up to 20–30% Benefits - 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 - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP) - 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

Role Description We’re looking for an Associate Director, Clinical Data Management on the Clinical Data Management (CDM) team to help us expand what’s possible for patients with serious diseases. Reporting to the Head of Clinical Data Management, you’ll be responsible for working in conjunction with the Clinical Project Manager and study team to ensure data review, project support, study document management and CRO oversight of: - DM timelines - EDC/IWRS set up - Study database design - Clinical data capture - Discrepancy management - Data reconciliation You will also provide SME support with Data Management related vendor audits, as well as authoring, review and revision of Insmed SOPs. In this role, you’ll have the opportunity to review and provide input into protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the programs. You’ll also: - Review/revise Data Management related study plans including Data Management Plan, Data Validation Plan and other study documents to ensure quality and standardization - Manage and oversee data management related activities with CROs and other external vendors - Work with vendor(s) in preparation of regulatory submissions, particularly to support the DM tasks such as transfer of data - Develop, review and revise global SOPs providing team training where applicable - Manage design and development of eCRFs, clinical review and communication with CRO - Oversee and manage the development and implementation of edit check specifications and work with CRO during programming & validation - Participate in monthly data reviews with clinical team to ensure accuracy, consistency and reliability of data - Work with CROs and study teams to ensure study databases are locked based on pre-defined criteria and timelines - Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner - Provide high quality services through efficient and compliant processes Qualifications - Bachelor’s degree - Minimum years of clinical data management experience in a biotech, pharmaceutical or CRO environment - Three (3) years of prior management experience - Hands-on experience with Electronic Data Capture systems (Medidata Rave required) - Experience in CRO and vendor management, including vendor budgeting and auditing - Experience in developing study documents and SOPs - Experience with multiple phases of clinical development - Excellent communication skills and ability to work in a cross-functional team environment - Strong collaboration skills regarding external and internal teams Requirements - Nice to have: Advanced degree Benefits - 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 - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP) - 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

Role Description We’re looking for an Associate Director, Regulatory Affairs Project Management on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Regulatory Affairs Project management, you’ll work with global submission teams to project, manage complex regulatory submissions from submission preparation to approval. What You'll Do: - Lead submission planning discussions with close collaboration with Regulatory team. - Ensure submission team is aware of upcoming deliverables and align on roles and responsibilities. - Understand the interdependence between submission activities and components. - Assess any issues, risks, or impacts due to changes in strategy and/or timelines quickly throughout the submission process. - Create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities, and timelines. - Coordinate post-initial submission activities in support of the approval process. - Utilize in-depth knowledge of global regulatory submission requirements, processes, and procedures. - Have hands-on experience coordinating and managing submission documents/components for simultaneous global regulatory submission projects in eCTD format. - Track timely delivery of submission components, including internal review and approvals. - Understand, adhere to, and advise others on global Regulatory Authority regulations and guidance. - Possess proven project management, organizational, and time management skills to manage multiple ongoing projects simultaneously. Qualifications - Bachelor’s Degree (in life sciences or chemistry preferred). - 7+ years of experience in regulatory affairs. - Project management experience in the pharmaceutical industry (preferably in the Gene Therapy space). - Expertise with Smartsheet and/or other project management tools. - Regulatory experience from pre-IND through Phases I-IV for FDA, EMA, MHRA, and PMDA. - Excellent written and verbal communication skills. - Excellent organizational skills and attention to detail. - Ability to lead in a matrix environment. - Software requirements: Veeva Vault RIM, Smartsheet, Microsoft Office. Requirements - Ability to present information in a clear and concise manner. - Commitment to deliver high-quality output. Benefits - 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, and caregiver support. - Flexible work schedules with purposeful in-person collaboration. - 401(k) plan with a competitive company match and annual equity awards. - Participation in our Employee Stock Purchase Plan (ESPP) and company-paid life and disability insurance. - Company Learning Institute providing access to LinkedIn Learning and skill-building workshops. - Employee resource groups, service and recognition programs, and opportunities to connect and volunteer.