The Senior Clinical Trial Manager oversees global phase I-IV clinical trials from startup through the Clinical Study Report, ensuring compliance with GCP and regulatory standards. They are responsible for managing study budgets, vendor relationships, project timelines, and mentoring clinical operations staff.
Formulate and implement global regulatory strategies to enable efficient product development for assigned programs. Serve as the primary regulatory contact for the US FDA and lead the preparation and submission of regulatory documentation.
The Associate Director, Programming will provide technical leadership as the Program Lead for an assigned compound, ensuring quality and timeliness of programming deliverables. They will collaborate with cross-functional teams and external vendors while overseeing contractors and coaching junior staff.
The Director of Biostatistics provides statistical leadership for clinical development plans and oversees the design, analysis, and reporting of clinical trials. They are responsible for managing CRO or internal teams, ensuring high-quality statistical output, and engaging with global regulatory agencies.
The Director, Medical Safety will lead a team of PV Scientists to oversee signal detection, risk management, and aggregate safety reporting throughout the product lifecycle. They will also serve as a strategic partner to cross-functional teams to ensure the timely identification and communication of product safety risks.
The Medical Science Liaison will build and maintain professional relationships with healthcare professionals to provide expert medical and scientific support for Insmed's therapeutic areas. Responsibilities include conducting scientific exchanges, presenting product data, gathering customer insights, and supporting clinical trial activities.
The intern will support the Clinical Development team by reviewing patient-level trial data and identifying trends or inconsistencies. They will also assist in data reconciliation, study tracking, and the preparation of materials for medical monitoring meetings.
The Senior Director will provide global regulatory leadership and strategic direction for assigned development programs across the product lifecycle. They are responsible for driving integrated global regulatory strategies and leading interactions with major Health Authorities like the FDA, EMA, and PMDA.
The Senior Director will lead global regulatory CMC strategy for gene therapy programs, ensuring compliance and efficient product development from early to late-stage. They will act as the regulatory lead at the CMC sub-team level, managing interactions with health authorities and overseeing the preparation of key regulatory dossiers.
The Associate Director will lead cross-functional initiatives to improve disease diagnosis experiences and manage the operational infrastructure for disease acceleration programs. This includes partnering with communication teams to drive awareness and overseeing agency relationships, budgets, and compliance documentation.
The CMC Lead will provide strategic and operational leadership for the development of gene therapy programs from early stages through commercialization. This role involves coordinating cross-functional activities across process development, manufacturing, quality, and regulatory teams while managing external CDMO/CRO partners.
The Therapeutic Specialist will develop and execute sales plans to maximize growth within the rare disease market while maintaining expert knowledge of the competitive landscape. They will collaborate with cross-functional partners and engage with healthcare professionals to achieve shared business objectives.
The Global Medical Affairs Head will define and execute the integrated medical strategy for the Neuro/Other Rare therapeutic area to maximize scientific leadership and program success. This role oversees a global organization and serves as a senior medical voice, ensuring scientific integrity and alignment across cross-functional stakeholders.
The Director, Medical Safety Lead serves as the subject matter expert for safety surveillance, risk management, and benefit-risk assessment for assigned gene therapy products. They are responsible for medical evaluation of adverse events, leading safety review teams, and providing expert input into regulatory and clinical development documentation.
The Senior Director will oversee the Drug Safety and Pharmacovigilance (DSPV) quality and compliance framework to ensure regulatory readiness and continuous improvement. They will lead compliance monitoring, manage quality events and CAPAs, and govern training and procedural standards across the PV system.
The Senior Manager, Clinical Supplier Quality leads supplier quality management activities for global clinical suppliers, ensuring compliance with regulatory requirements and internal quality standards. They manage supplier qualification, performance monitoring, risk assessments, and the development of Quality Technical Agreements to support clinical development programs.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will serve as a field-based expert, connecting HCP insights with internal research and commercial strategies while supporting clinical development programs.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will also serve as a field-based expert, connecting clinical insights with internal research and commercial strategies.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support for PAH, IPF, and PPF. They will also serve as a field-based expert, translating field insights into actionable strategies while collaborating with cross-functional teams.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will serve as a field-based expert, translating clinical insights into actionable strategies while collaborating with cross-functional teams.
The Associate Director, Medical Science Liaison will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support. They will also serve as a field-based expert, connecting healthcare professional insights with the company's research and commercial strategy.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will also serve as a field-based expert, translating clinical insights into actionable strategies while supporting clinical development and medical affairs initiatives.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will serve as a field-based expert, translating clinical insights into strategy and supporting clinical development programs.
The Director of Medical Insights & Analytics will develop and lead analytic capabilities to support data-driven decision-making within Medical Affairs. This role involves collaborating with cross-functional teams to track medical activity, report metrics, and identify actionable insights to inform global strategy.
The intern will support Quality Assurance activities for clinical programs, including the design of a QA Metrics Dashboard and analysis of quality systems at contract manufacturing organizations. They will also collaborate with cross-functional teams on quality initiatives, SOP development, and AI-driven projects.
The Therapeutic Specialist will develop and execute sales plans to maximize growth within the rare disease market in the Kansas City East territory. They will collaborate with cross-functional partners and engage with healthcare professionals to achieve business objectives while maintaining high ethical standards.
The Executive Director will lead the strategic direction of the Pharmaceutical Development function for the small molecule pipeline, overseeing formulation, manufacturing readiness, and CMC innovation. They will partner with cross-functional teams to ensure efficient progression of assets from early development through commercialization while aligning with corporate and regulatory goals.
The Executive Director will lead the strategic direction of API development for the small molecule pipeline, overseeing synthesis, process development, and manufacturing readiness. They will serve as a key advisor to executive leadership and manage cross-functional initiatives to ensure seamless program advancement from discovery through commercialization.
The Field Access Manager will resolve patient-specific access barriers and educate healthcare provider office staff on prior authorization and appeals processes. They will also serve as a reimbursement expert while collaborating with internal teams to monitor patient start trends and address access challenges.
The manager will lead cross-functional CMC teams to drive complex pipeline projects from research transition through development, registration, and commercial readiness. They are responsible for establishing project frameworks, managing risks, and ensuring alignment across internal departments and external partners.
The Associate Director will lead CMC regulatory strategy development and implementation for assigned development and post-approval programs in the EMEA region. They will coordinate regulatory submissions, author CMC sections for filings, and ensure compliance with EMA, ICH, and other relevant regulatory standards.
The intern will design and develop AI tools to support healthcare compliance operations and assist with monitoring and record reviews. They will also collaborate across departments to reinforce ethical conduct and present a capstone project to senior leadership.
The Senior Manager will provide statistical expertise for clinical trials, supporting the design, execution, and reporting of studies. They will collaborate with cross-functional teams to ensure statistical integrity and contribute to regulatory submissions.
The Director, Brand Counsel serves as the primary legal advisor for a marketed respiratory product, providing strategic guidance on promotional and scientific materials. This role involves collaborating with cross-functional teams to ensure compliance with FDA and FTC regulations while managing legal risks and contract reviews.
The Senior Director will provide regulatory CMC leadership and strategy to achieve global approvals for drug products throughout their lifecycle. They will manage regulatory submissions, lead agency interactions, and collaborate with cross-functional teams to resolve technical and regulatory challenges.
The Director leads the medical and scientific review of US and global promotional and medical materials to ensure accuracy, scientific integrity, and regulatory compliance. They serve as a core member of the Medical and Commercial Review Committees, partnering with cross-functional teams to guide compliant content development.
The Medical Science Liaison will build and maintain professional relationships with healthcare professionals to provide expert medical and scientific support across rare, pulmonary, and infectious disease areas. Responsibilities include conducting scientific exchanges, presenting product data, supporting advisory boards, and assisting with clinical trial activities.
Provide medical expertise for the safety and risk assessment of products throughout the entire product life cycle. Author, review, and approve drug-safety related regulatory reports and clinical study documentation.
The Field Access Manager will assist in resolving patient-specific access barriers and educate healthcare provider office staff on prior authorization and reimbursement processes. They will also monitor patient start trends and collaborate with internal teams to address emerging access challenges within their assigned geography.
The Senior Manager will oversee API, intermediate, and RSM manufacturing at CMOs, including tech transfer, process optimization, and validation. They will also serve as an internal subject matter expert, providing technical support and managing process improvement projects.
Manage API, intermediate, and RSM manufacturing at CMOs, including oversight of tech transfer, process optimization, and clinical/commercial manufacturing. Act as the internal technical SME and collaborator with research teams to drive discovery process chemistry and CMC development strategy.
Manage API, intermediate, and RSM manufacturing at CMOs, including synthesis route identification, tech transfer, and process optimization. Act as the internal subject matter expert to drive cross-functional collaboration between research and CMC development teams.
The Vice President and Global Head of DSPV will lead the global pharmacovigilance team to ensure patient safety through robust safety evaluation and medical innovation. This role is responsible for driving enterprise-wide strategic initiatives to modernize PV infrastructure and maintaining full compliance across all global markets.
The Field Access Manager will collaborate with internal teams to resolve patient-specific access barriers and educate healthcare provider offices on reimbursement processes. This role involves monitoring patient start trends and serving as a reimbursement expert within the assigned geography.
The Field Access Manager will support patient access to prescribed treatments by resolving access barriers and educating healthcare provider offices on reimbursement processes. They will collaborate with internal teams to monitor patient start trends and ensure efficient navigation of payer requirements.
The manager will oversee contract manufacturing organizations to ensure robust production, technology transfer, and process optimization. They are responsible for troubleshooting equipment, executing validation protocols, and maintaining compliance with GMP and regulatory standards.
The Director will lead and implement innovative diagnostic approaches for respiratory patients and identify high-priority external collaborations. They will also design initiatives to drive clinical screening and develop tools to improve patient risk stratification and diagnostic efficiency.
The Director of Access Programs is responsible for the strategy and management of patient assistance and copay programs, including vendor oversight and business rule optimization. This role collaborates cross-functionally to ensure operational excellence and deliver patient solutions aligned with business objectives.
The Director of Competitive Intelligence will lead the monitoring, synthesis, and communication of competitive developments to inform brand strategy and pipeline prioritization. They will collaborate with cross-functional teams to deliver actionable insights that support commercial effectiveness and asset decision-making.
The Director will lead U.S. expert engagement and regional marketing strategies across pulmonary and rare disease portfolios. They will coordinate advisory boards, drive HCP awareness, and translate scientific insights into actionable commercial plans.
The Director will define and drive the Commercial data innovation strategy by identifying and prioritizing high-value use cases across the organization. They will partner with cross-functional teams to ensure scalable, compliant, and effective implementation of data and advanced analytics solutions.
The role provides clinical evaluation for potential in-licensing or acquisition opportunities and supports cross-functional planning for molecules emerging from discovery platforms. It involves designing clinical studies and development plans while maintaining partnerships with external medical experts.
The Director is responsible for safety surveillance, risk management, and medical assessment of adverse event reports for assigned products. This includes leading Safety Review Teams and ensuring compliance with US, EU, and international regulatory standards.
Lead a team of 10 Field Access Managers to address challenges impacting patient access to products and optimize the reimbursement process. Collaborate with cross-functional leadership to identify access bottlenecks and ensure compliant alignment with patient priorities.
Lead commercial data acquisition and business-led partnerships to drive insight generation and innovation across the Commercial Effectiveness organization. Define and execute RWD strategies while managing vendor relationships and ensuring regulatory compliance with HIPAA and GDPR.
Build and maintain professional relationships with healthcare providers and researchers to provide scientific support for rare, pulmonary, and infectious diseases. Conduct scientific exchanges, present product data, and gather clinical insights to align with Medical Affairs plans.
Develop and execute a sales plan to maximize growth within the rare disease market across Utah. Collaborate with cross-functional partners and establish relationships with healthcare providers and thought leaders.
Lead the strategic and operational oversight of Clinical Data Management across the development portfolio from early stages through regulatory submissions. Drive modernization initiatives including AI-enabled workflows and automation to ensure high-quality, inspection-ready clinical data.
Lead the strategic integration of AI and automation within HR operations to optimize processes and scalability. Architect HR process maps and govern knowledge infrastructure to transition the organization toward human-AI collaboration.
Manage the outsourcing, design, and oversight of safety pharmacology and toxicology studies conducted at contract research organizations (CROs). Collaborate with cross-functional teams to ensure high-quality data generation and contribute to nonclinical sections of regulatory submission documents.
The Specialist, DSPV Compliance will ensure pharmacovigilance activities comply with global regulations and company policies. Responsibilities include document management, training support, and compliance-related activities.
Lead the US Respiratory Value and Access strategy to ensure product coverage and accessibility for patients. This involves developing economic narratives, pricing assessments, and partnering with cross-functional teams to align clinical trial design with reimbursement goals.
Lead the development and implementation of global medical communications strategies and scientific platforms for respiratory therapeutic areas. Coordinate cross-functional teams to execute scientific deliverables, including congress strategies, field medical tools, and sponsored medical education.
Lead US-based patient advocacy and professional society engagements focusing on Bronchiectasis and NTM Lung Disease. Act as the bridge between patient communities and the organization to ensure the patient voice influences clinical development and business decisions.
The Senior Manager, GxP Audit Program is responsible for overseeing and managing the external supplier audit program across various GxP domains. This includes ensuring audits are planned and executed in a consistent and risk-based manner while collaborating with stakeholders to enhance audit quality.
You will oversee Drug Safety and Pharmacovigilance Operations and Vendor Management activities, ensuring compliance with regulatory requirements and internal procedures. This includes managing vendor performance, supporting clinical studies, and enhancing operational processes.
Develop and execute a sales plan to maximize growth within the rare disease market. Collaborate with cross-functional partners and establish relationships with healthcare providers and thought leaders.
Develop and implement global medical affairs strategies and plans for respiratory indications to ensure alignment with company objectives. Coordinate across functional areas including HEOR, Scientific Communications, and regional teams to optimize medical activities and data generation.
Lead regulatory strategy and operational leadership for early-stage drug development and business development assets. Act as the primary regulatory contact for the U.S. FDA and conduct due diligence assessments for external assets.
Lead the global commercialization of ALS and Rett gene therapies, focusing on strategy development, market shaping, and patient finding. Collaborate with cross-functional teams to integrate commercial insights into clinical development and ensure high-quality customer engagement.
Monitor global regulatory intelligence and emerging trends to support strategic business objectives and program assessments. Lead cross-functional policy projects and drive continuous improvement of internal processes and tools.
Build and maintain professional relationships with healthcare providers and researchers to provide scientific support for rare, pulmonary, and infectious diseases. Conduct scientific exchanges, present product data, and gather clinical insights to align with Medical Affairs plans.
Develop and execute a sales plan to maximize growth within the rare disease market across Northern Houston and surrounding territories. Collaborate with cross-functional partners to build relationships with healthcare providers and emerging thought leaders.
Lead the commercial evaluation and strategic positioning of external business development opportunities, including acquisitions and partnerships. Drive end-to-end diligence processes and develop integrated business cases to inform enterprise-level decision making.
Provide statistical expertise for clinical trials, including the design, execution, and reporting of studies. Collaborate with cross-functional teams to ensure statistical integrity and compliance in regulatory submissions.
The role provides operational support for respiratory therapeutic brands, focusing on print production, fulfillment, and the streamlining of marketing materials through the Commercial Review Committee. It involves managing vendor relationships, orchestrating inventory planning, and coordinating the end-to-end promotional review cycle.
The Senior Manager will oversee daily 3PL operations, including warehousing, fulfillment, and distribution of pharmaceutical products. They will ensure compliance with DSCSA, GDP, and GXP requirements while managing relationships with third-party logistics providers and specialty distributors.
Lead and expand a team of computational biologists to develop AI-driven protein design and optimization methods for biotherapeutic discovery. Partner with experimental teams and IT stakeholders to integrate computational research into drug discovery programs and corporate strategy.
The Senior Director will provide strategic leadership for the Field Medical Excellence team, developing long-term roadmaps for capabilities across the US, Europe, and Japan. They will drive consistency in field medical processes, tools, and systems while collaborating with global leadership to ensure integrated planning.
The Director, US Compliance – Business Partner serves as a trusted advisor to cross-functional teams, providing proactive guidance on laws, regulations, and industry standards. This role involves embedding compliance as a strategic enabler throughout program development, managing investigations, and fostering a culture of integrity across the organization.
The manager will lead the end-to-end development, negotiation, and lifecycle management of pharmacovigilance agreements with external partners. They will also ensure contractual compliance with global regulatory requirements and drive process improvement initiatives across the organization.
The Senior Director will develop, implement, and lead the therapy strategy and planning for Medical Affairs across all geographic regions, ensuring a cohesive approach. This includes driving the execution of Medical Affairs plans, providing medical leadership input to cross-functional partners, and building external relationship networks within the respiratory therapy area.
This role involves leading clinical programs in neurology, supervising the clinical development team, and serving as the primary point person for medical monitoring and data interpretation for assigned clinical studies. The individual will also be crucial in formulating the company’s neurology pipeline and portfolio expansion in collaboration with research and commercial departments.
The Senior Director will develop, implement, and lead therapy strategy and planning for Medical Affairs across all geographic regions to ensure a cohesive approach. This includes driving the execution of Medical Affairs plans, providing medical leadership input to cross-functional partners, and building an external relationship network within the respiratory therapy area.
