Insmed Incorporated

Project Manager, Technical Operations Remote Location: Bridgewater, New Jersey (NJ Corporate Headquarters) Full time 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.remo 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 Project Manager, Technical Operations on the Project and Strategy Management team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Manager, Project Management, you’ll responsible for leading cross-functional project execution and ensuring successful delivery of Technical Operations initiatives from early development through readiness for registration and filing. This role focuses on driving project execution, facilitating alignment across functions, and ensuring operational excellence across Technical Operations programs. What You'll Do: In this role, you’ll have the opportunity to drive the transition of projects from Research into Technical Operations through readiness for registration and filing. You’ll also: - Lead cross-functional project teams for Technical Operations activities, both within Insmed and with external partners - Ensure alignment across key functions including Manufacturing, Analytical Development, Quality Assurance, and Regulatory, with input from Commercial, Research, and Clinical - Develop, maintain, and execute detailed project plans to ensure timely and successful delivery - Identify, assess, and manage project risks; develop contingency plans and escalate key issues to leadership as needed - Facilitate effective communication across project teams and stakeholders at all levels of the organization - Track project deliverables and ensure timely reporting to stakeholders - Represent Technical Operations in cross-functional and project governance meetings - Support the implementation and continuous improvement of project management tools, processes, and metrics - Partner with cross-functional stakeholders to enhance the use of project management tools and drive operational efficiency Contribute to additional projects and initiatives as required Who You Are: You have a Bachelor’s degree in a technical discipline and approximately 5+ years of project management experience in the pharmaceutical, medical device, or related industry. You are or you also have: - Demonstrated ability to influence outcomes without direct authority and hold teams accountable to commitments - Proven experience working effectively within cross-functional, high-performing teams - Strong leadership skills with the ability to operate in fast-paced, dynamic environments - Excellent communication and collaboration skills across multiple departments - Working knowledge of key functional areas across the product lifecycle (Research, Preclinical, Clinical, Regulatory, Operations, Quality Assurance, etc.) - Ability to work effectively within a highly regulated environment - Innovative mindset with a proactive and solutions-oriented approach - Strong technical and computer skills (e.g., MS Project, Excel, PowerPoint, SharePoint) and familiarity with web-based tools Nice to have (but not required): - PMP certification is a plus, but not required Where You’ll Work This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most. #LI-HYBRID Pay Range: $124,000.00-161,000.00 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.

Role Description This role serves as the strategic and operational backbone of People function, owning and evolving process enablement, AI readiness, training, and knowledge infrastructure across all HR COEs. Positioned as a critical connector between HCM, IT, and the broader employee experience, this role ensures that People Operations runs with precision, scalability, and innovation. This role is the HR function's primary architect and steward of AI orchestration readiness - building the process, governance, and enablement foundation required for the organization to responsibly adopt, scale, and derive strategic value from emerging technologies, including agentic AI, intelligent automation, and generative AI tools across People Operations. What You'll Do - Partner with Organization Transformation, leveraging the Transformation COE framework, to lead communication planning and enablement execution for HR technology projects, policy updates, and AI adoption initiatives. - Develop targeted enablement campaigns, engagement tracking, and manager toolkits that drive measurable uptake and support the organization's shift from manual process execution to human-AI collaboration. - AI Orchestration & Strategy: - Serve as HR's primary subject matter expert for AI, automation, and intelligent workflow tools. - Define and maintain an AI orchestration roadmap for People Operations - identifying HR workflows suited for agentic automation and sequencing adoption to build organizational readiness progressively. - Evaluate, Pilot & Scale: - Lead assessment and scaling of AI-powered HR solutions including generative AI, AI-driven analytics, intelligent process automation (IPA), HR chatbots/virtual assistants, and agentic AI workflows. - Partner with IT, Legal, and vendors to evaluate tools against regulatory compliance, data security, and enterprise architecture requirements. - AI Governance Framework: - Partner with the IT PM function to build and maintain an HR AI Governance Framework covering responsible use policies, bias monitoring, data privacy compliance, audit trails, and human-in-the-loop oversight protocols for AI agent ecosystems operating across Workday, ServiceNow, and related platforms. - AI Literacy Program: - Serve as a partner to L&D to develop and deliver AI literacy curricula equipping HR teams and end-users with responsible use principles, prompt literacy, and workflow integration skills to confidently engage with AI tools as collaborative partners. - Process Design & Documentation: - Architect and maintain detailed, scalable HR process maps and workflows across HR functions, regions, and technology platforms - with AI-readiness and automation-compatibility as design-first principles. - Create and govern documentation, templates, and definitional guidance across the HR ecosystem; apply process improvement methodologies (Lean, Six Sigma, or equivalent) to systematically identify inefficiencies and design process enhancements and scalable solutions in partnership with Legal and IT. - HR Policy Management: - Maintain accurate HR policies, procedures, and Employee Handbook in partnership with HR leadership and Legal - leveraging AI-assisted tools to enable dynamic, searchable, version-controlled, and proactive policy access globally. - Continually assess and recommend policy enhancements aligned with regulatory changes and Insmed's strategic direction. - Knowledge Management: - Own and maintain internal knowledge platforms (HR Central, HCM Central, Workday Central); implement AI-assisted knowledge tools that improve content discoverability and reduce time-to-answer. - Training, Enablement & HR Tech Onboarding: - Partner with L&D to design and deliver engaging training for employees, managers, and HR teams across all system and process changes. - Build a dynamic knowledge library (QRGs, micro-learnings); deliver onboarding for new HR system users, administrators, and functional partners. Qualifications - Bachelor's degree required; Master's degree in HR, Business, Organizational Development, Information Systems, or related field preferred. - 8+ years of progressive HR or People Technology experience required; prior experience in Pharma and/or Biotech strongly preferred. Requirements - Experience developing and/or evolving HR processes & policies; preferably as an Offering Manager leading the design, development, deployment, and ongoing management of an HR offering. - Demonstrated experience evaluating, piloting, and scaling AI-powered HR tools, automation platforms, or intelligent workflow solutions. - Strong functional expertise in designing HR processes based on business needs, with the technical capability to implement and optimize those processes within an HR platform. - Familiarity with AI/ML concepts, natural language processing (NLP), large language models (LLMs), agentic AI, and intelligent process automation (IPA). - Working knowledge of process improvement methodologies (Lean, Six Sigma, or equivalent); proficiency with AI productivity tools, knowledge management platforms. - Excellent analytical, verbal, and written communication skills; ability to translate complex technical concepts for all organizational levels. - Highly organized with strong attention to detail, accuracy, and ability to manage multiple priorities simultaneously while maintaining a high level of confidentiality. - Comfortable operating in ambiguity and rapidly evolving technology environments. 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 a Senior Scientist, Study Toxicologist on the Nonclinical Safety team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Toxicology Study Operations you’ll play a critical role in collaborating with project toxicologists and managing the outsourcing, design, and oversight of safety pharmacology and toxicology studies at contract research organizations (CROs). What You'll Do: - Collaborate with toxicology project leads and subject matter experts (e.g., discovery, bioanalysis, pharmacokinetics, CMC) to design safety pharmacology and toxicology studies, aligning with company objectives and regulatory standards. - Serve as the primary sponsor representative for CROs, handling all aspects of study outsourcing, including requesting quotes, negotiating contracts, and managing study timelines. - Oversee the design, execution, and data interpretation of nonclinical safety studies conducted at CROs, ensuring robust and high-quality data generation. - Review study reports and SEND datasets to ensure quality, timeliness, and readiness for regulatory submissions. - Effectively communicate study findings to toxicology project leads and senior management, addressing and resolving any study-related issues promptly. - Contribute to the preparation, review, and/or QC of nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific Advice, annual reports, briefing documents) as needed. - Participate in issue-resolution teams, providing scientific guidance to address toxicology-related challenges and drive effective problem-solving. - Develop and enhance departmental SOPs and best practice documents to improve study operations and ensure regulatory compliance. Qualifications - You have a PhD or an MS and 3 years of toxicology experience or a BS and 5 years of toxicology experience in the pharmaceutical/biotechnology industry or at CROs. - Expertise overseeing safety pharmacology studies. - Proven track record of successfully directing and/or monitoring toxicology studies across various modalities, including small molecules, biologics, antisense oligonucleotides, and gene therapies. - Advanced knowledge of toxicology in support of drug development. - In-depth understanding of GLP regulations and regulatory guidance for nonclinical evaluations. Requirements - 5+ years of hands-on experience as a study director and/or monitor in toxicology (nice to have but not required). - Interest in expanding your experience with general toxicology studies. - Demonstrated enthusiasm for scientific research and a commitment to maintaining high-quality standards in toxicology study operations. - Strong strategic thinking, critical analysis, and leadership capabilities. - Self-motivated to meet performance objectives and to prioritize job-related tasks. - Ability to adapt to dynamic project needs and manage studies across different time zones. - Excellent interpersonal, communication, and negotiation skills, with a collaborative mindset. - Willingness and flexibility to travel on business to CROs. 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. 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.

Role Description We’re looking for a Specialist, DSPV Compliance on the Drug Safety & Pharmacovigilance (DSPV) team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, DSPV Compliance, you’ll be responsible for ensuring that pharmacovigilance activities are compliant with global pharmacovigilance regulations (i.e. GVP, Good Pharmacovigilance Practices), company policies, and industry standards by assisting with and supporting pharmacovigilance activities and deliverables related to document management, training, quality and compliance, and audit and inspection readiness within the scope of the Drug Safety and DSPV Department at Insmed. In this role, you’ll have the opportunity to collaborate cross-functionally with internal teams and external stakeholders to achieve business objectives. You'll also: - Assist with the development, review, and approval of DSPV controlled documents, including SOPs, Policies, Templates, and Forms. - Support the maintenance of relevant team trackers, documents, and folders maintaining accuracy, organization and efficiency in document management processes. - Assist with the scheduling, documentation, and tracking of all Adverse Event Reporting Trainings for all Insmed Representatives. - Support the facilitation of DSPV training to ensure the DSPV team receives the role-specific curricula tailored to their responsibilities. - Assist in initiating, tracking, monitoring, and following up on non-compliance matters for Insmed and PV-Related vendors as needed. - Support the review and management of deviations, CAPAs, Quality Events, and other compliance-related activities (including but not limited to Note to Files, Storyboards, etc.) as required. Qualifications - Minimum of a Bachelor’s degree. - At least 2 years of relevant Pharmacovigilance experience. - Excellent Microsoft Office (Word, Excel, PowerPoint) experience. - Proven ability to manage competing deliverables while prioritizing time effectively based on project needs. - Problem solving and the ability to be coached and directed by other teammates and partners. - Ability to seek guidance/input from others when faced with a difficult situation. - Attention to quality, detail, and accuracy. Requirements - 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. - This role requires occasional domestic travel (approximately 5%–10%). 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 an Executive Director, Respiratory Value and Access Lead on the Market Access team to help us expand what's possible for patients with serious diseases. Reporting to the VP, US Market Access, you'll develop strategies that ensure Insmed's portfolio of respiratory disease products is covered by payers and accessible to patients. You'll bridge the gap between clinical development, regulatory approval, and commercialization — focusing on reimbursement, pricing, and health economic evidence, while continuously monitoring opportunities and risks to US payer coverage and provider reimbursement. In this role, you'll have the opportunity to lead Respiratory Value and Access strategies and drive execution through close cross-functional partnership. You'll also: - Lead development of US Respiratory Value and Access strategy for launch preparedness, while aligning and contributing to HEOR evidence generation plans to define and deliver long-term value narratives to economic decision makers. - Partner with Global Program Teams, EMEA and Japan Market Access Teams, Commercial Effectiveness, HEOR, Managed Care, Channel/Trade, Patient Services and Field Access to develop compelling economic narratives, robust value propositions and optimized evidence plans to support access and reimbursement. - Work with internal teams to align product value with clinical trial design and regulatory strategy. - Lead strategic pricing assessments and recommendations for Respiratory pricing and contracting strategies. - Lead and influence cross-functional partners and senior business leaders relative to access dynamics and strategy. - Partner with HEOR and Managed Care leadership to develop evidence-based dossiers that demonstrate the long-term clinical and economic impact of the therapy to payers. - Coordinate with Managed Care Team to support payer engagement activities, distribution and patient services. - Develop contracting strategy to secure favorable and profitable coverage while managing payer costs and mitigating risk. - Monitor policy, reimbursement, and pricing landscape to assess potential business impact. Qualifications - Master's Degree with 10+ years of experience in market access, HEOR and/or pricing, or a Bachelor's Degree with 12+ years of experience in the same fields. - Direct experience in Respiratory value and access. - Deep understanding of payer access dynamics across various administration modalities and the US policy landscape. - Demonstrated ability to recognize and interpret business issues/opportunities and make/recommend sound business judgments regarding solutions. - Proficiency in financial modeling, data analysis, and developing value tools (e.g., PowerPoint, Excel). - Strong negotiation, cross-functional leadership and communication/presentation skills to influence without direct authority. - Excellent communication, collaboration, strategic and analytical skills. - Ability to work optimally in cross-functional teams in a fast-paced, dynamic environment. Requirements - Experience in ex-US markets (EMEA, Japan) is 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 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. 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.

Role Description We’re looking for a Director, Scientific Communications to help us expand what’s possible for patients with serious diseases. Reporting to the Global Medical Lead, the Director, Scientific Communications will, as a core member of the Global Medical Strategy team, lead the development and implementation of global Medical Communications Strategy globally and across regions. - This role will have high visibility within the medical organization and requires the ability to lead cross-functional teams in a matrixed organization. - A core responsibility will be to co-lead the development and maintenance of scientific platforms and the strategic execution of aligned scientific communications deliverables. - Ensure a global approach that accurately and consistently communicates about Insmed disease areas of interest and Insmed generated data. - Develop collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development, Advocacy, Commercial, and Market Access) as well as external medical experts. - Drive the planning and execution of scientific communications deliverables across the assigned therapeutic area(s), including field medical tools and resources and sponsored medical education through an omni-channel approach. Qualifications - Master’s degree in a scientific discipline. - 8+ years of relevant experience in the pharmaceutical/biotech industry, primarily in the Medical Affairs function. - 5+ years’ experience and demonstrated success in the design and implementation of Medical Communication Strategies. - Expert knowledge of relevant guidance including Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines and CME Open Payments reporting. - Expertise in the assessment and application of scientific/clinical data to strategy with pull through to externally facing deliverables. - Proven ability to interpret and organize highly complex scientific data. - Experience in a leadership role in designing scientific communications strategy in alignment with corporate strategy. - Experience working closely with external experts and authors. - Demonstrated experience managing competing priorities and tight deadlines. - Ability to manage external vendors and provide clear, concise direction. - Excellent written and verbal communication skills. - Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Requirements - An advanced degree (PhD, PharmD, or MD) is preferred. - Experience within the respiratory therapeutic area is preferred. - Prior pre-launch/launch experience preferred. 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. 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.

Role Description Reporting to the Director, Supplier Quality, the Senior Manager, GxP Audit Program is responsible for oversight and management of the external supplier audit program across GMP, GCP, GLP, and GVP (GxP) domains. The role ensures audits are planned, executed, and managed in a consistent, risk-based, inspection-ready, and business-aligned manner in accordance with global regulatory expectations. You will serve as the central point for audit program governance, including: - Audit planning - Auditor qualification and competency - Observation management - Risk communication - Continuous improvement Working collaboratively with stakeholders, SMEs, and suppliers, the role strengthens audit quality, consistency, and risk focus across the global supplier network. A solution-oriented and forward-thinking mindset is required to proactively identify gaps, optimize resources, and drive continuous improvement initiatives. You will lead the harmonization of the audit program across all GxP areas by establishing aligned scope, regulatory frameworks, and scalable operational structures. What You'll Do In this role, you'll have the opportunity to develop and manage a global, risk-based supplier audit program across GxPs including defining audit strategy and annual plans based on supplier criticality, risk classification, and regulatory expectations. You will also: - Establish and standardize audit governance, procedures, and processes to ensure consistent planning, execution, reporting, and follow-up. - Lead structured audit planning and debriefing strategy and risk prioritization by reviewing supplier performance data. - Standardize audit tools, checklists, and risk models across regions and GxP domains. - Establish and maintain centralized oversight of supplier audit observations across all GxP areas. - Drive consistency in supplier CAPA evaluation, closure timelines, and effectiveness verification. - Lead the auditor competency program across GxPs. - Identify training gaps and implement targeted development plans. - Lead peer reviews of audit reports and collaborate with subject matter experts and auditors. - Support regulatory inspections by providing audit documentation, risk assessments, and supplier oversight evidence. - Conduct audits with a diplomatic and professional approach. Qualifications - Minimum of a Bachelor of Science in Pharmacy, Chemistry, Engineering, Life Sciences, or related discipline. - 12 years of progressive Quality Assurance experience within pharmaceutical, biotechnology, or medical device industries. - Minimum 5 years of direct experience conducting and leading external supplier audits. - Demonstrated experience managing or coordinating audit programs across multiple regions and regulatory frameworks. - Experience supporting Health Authority inspections involving supplier oversight. - Broad GxP Familiarity: Supporting knowledge of related frameworks such as GDP, GVP, or GLP. - Quality Fundamentals: Deep understanding of ICH guidelines, data integrity principles, and risk management methodologies. - Excellent technical writing, communication, negotiation, and stakeholder influence skills. Requirements - Demonstrated ability to independently plan and execute audits across multiple supplier types. - Assess complex quality systems, identify compliance gaps, evaluate corrective and preventive actions. - Apply sound risk-based decision making supported by strong analytical and data proficiency. Benefits - Comprehensive medical, dental, and vision coverage and mental health support. - Generous paid time off policies, fertility and family-forming benefits, caregiver support. - 401(k) plan with a competitive company match and annual equity awards. - Company Learning Institute providing access to LinkedIn Learning and skill-building workshops. - Employee resource groups, service and recognition programs, and meaningful opportunities to connect. 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.

Role Description We’re looking for an Associate Director, Medical Strategy Respiratory on the Medical Strategy and Communications team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Medical Director, Global Medical Strategy and Communications, you’ll assist in the development and implementation of the indication strategy and planning for Medical Affairs across all geographic regions ensuring a cohesive approach. This role is strategic, dynamic, and responsible for providing coordination and contributions to the strategic optimization of Medical Affairs across the five functional areas. - US, Japan, and EMEA Regional Teams - Global Medical Strategy - Scientific Communication & Publications - HEOR - Global Medical Excellence - Medical Information Additionally, you will maintain a high-level cross-functional collaboration across the organization to ensure alignment and Program First Insmed approach. What You'll Do - Develop and execute Medical Affairs plans: ensure the program strategy is reflected in medical plans and that these deliver on critical identified milestones in launch planning. - Provide strategic medical leadership and scientific input to cross functional partners including clinical, operations, HEOR and commercial to ensure decisions are grounded in strong medical and patient-centric perspectives. - Build and maintain strategic relationships with external experts and other stakeholders to inform strategy, gather insights, and strengthen disease-state leadership. - Support the development and execution of the data generation strategy, help shape the publication priorities and evolve the evidence generation plans in alignment with the Program First strategy. - Collaborate in the review of scientific communication materials, FAQ and standard responses, and contribute to develop internal training materials to support compliant scientific exchange. - Partner with Medical Strategy, Regions, and Finance to plan and manage annual budget for medical activities. - Ensure a comprehensive and synergistic medical affairs approach by collaborating across medical functions, regions, and other functions including commercial, market access, and development. - Support budget planning, monthly tracking and reporting. - Partner with stakeholders to identify and integrate innovative ideas and best practices into strategies, plans, and activities. - Drive a One Insmed and respiratory Franchise approach. - Maintain the highest standards of scientific integrity and ensure all activities are conducted in accordance with Insmed policies. Qualifications - MD degree, PharmD or PhD along with minimum 3 years of relevant experience. - Ability to work independently and comfortable to represent medical affairs within cross functional teams. - Ability to operate seamlessly in a matrix organization. - Previous experience in medical affairs and ability to lead by influence within a matrix team. - Ability to work collaboratively with multiple stakeholders and functions. - Proven track record of leading process and operational excellence and developing planning standards. - Strong strategic thinking with ability to connect multiple components. - Proven track record of effectively driving change. - Strong communication skills (written, verbal) and attention to detail. - Enables creative problem solving, encourages unique solutions, and effectively solves challenges problems. Nice to have (but not required) - Previous experience in pulmonology. - Strong knowledge of Medical Affairs and understanding of medical affairs planning required with previous launch experience. - Global experience or experience in multiple regions including the US. 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 role requires occasional domestic/international travel (approximately 15%). Pay Range $164,000.00-213,000.00 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’re looking for an Associate, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Clinical Trial Operations, 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 assure compliance with SOPs, FDA regulations, GCP and ICH guidelines. What You'll Do: - Be responsible for the collection of trial-related documents and maintenance of both paper and electronic Trial Master File (TMF). - Assist in periodic TMF quality control checks through the course of study as defined by the clinical study team, per ICH/GCP requirements. - Be responsible for the QC activities of the Sponsor- and CRO-supported TMF at intervals specified in project plan and/or applicable SOPs and/or prior to the transition of the TMF to Insmed at end of study. - Partner with Quality Assurance team to assist with performing audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts. - Participate in the review of clinical trial agreements, work orders, and other site/vendor agreements. - Assist in the review and processing of invoices related to study agreements. - Assist with the tracking and documenting of site and sponsor training (e.g., Study specific, drug and program level). - Participate in clinical study team and vendor meetings; schedule meetings, draft and finalize meeting action items. - During CST meetings, provide updates on health and currency of study TMF. - Assist in review of CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials. - Assist in coordinating activities related to Regulatory Inspection (e.g., prep, retrieval of documents and other activities and support). - Support Vendor audits, when needed. - Process payments to vendors via Procurement system. Qualifications - Bachelor’s degree in life science, healthcare, or related field. - 1+ year of experience in pharmaceutical/biotech industry. - Experience in clinical research and basic knowledge of Good Clinical Practice (GCP) and ICH guidelines in clinical trials. - Good verbal communication and writing skills, and good interpersonal/group skills. - Ability to demonstrate flexibility, agility and working within a multi-functional, global matrix. - Demonstrated efficiency with multi-tasking and prioritization. - Collaborative approach to process development, issue resolution/risk management. - Roll-up-your-sleeves orientation and a strong ability to work in a globally team-based environment. Requirements - Experience with TMF, both paper and electronic (eTMF) preferred. 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). - 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 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. What You'll Do: - Develop and implement clinical operations strategies, aligned with corporate objectives and Program goals. - 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. Qualifications - Bachelors degree in life sciences, healthcare or a related field. - 12+ years of progressive clinical research/operations experience in the pharmaceutical/biotech industry. - 5+ years in senior leadership roles managing clinical operations teams. - 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 Health Authority inspections. Requirements - Up to 25% domestic and international travel may be required for site visits, supplier meetings, and cross-functional/team collaboration. 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). - 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.