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 Senior Manager leads and oversees global GCP and GLP supplier quality management activities to ensure compliance with regulatory requirements and internal standards. They partner with cross-functional teams to manage supplier qualification, performance monitoring, risk assessment, and quality agreement governance.
The Senior Specialist manages the lifecycle of Quality Technical Agreements and leads GMP audits of external suppliers, contract manufacturers, and service providers. They also support supplier qualification, risk assessments, and regulatory inspection readiness as a subject matter expert.
The Regional Sales Director will lead and develop a high-performing sales team to execute regional sales strategies and maximize growth in the rare disease market. They will collaborate with cross-functional partners to ensure launch excellence and maintain high ethical standards across the North Texas region.
The Director, Field Strategy will lead the development and evolution of field force strategies, including sizing, structure, and geographic optimization to maximize commercial impact. They will act as a strategic liaison between field-based teams and global program teams to ensure commercial execution is data-driven and aligned with business objectives.
The Associate Director provides medical expertise for the safety and risk assessment of products throughout their life cycle, from clinical development to post-marketing. They are responsible for evaluating safety data, conducting medical reviews of adverse event reports, and authoring regulatory safety documents.
The Associate Director serves as the business owner for pharmacovigilance safety systems, overseeing the technology roadmap, vendor relationships, and system implementation. They collaborate with IT and cross-functional teams to ensure safety data integrity, regulatory compliance, and the integration of AI-driven analytics.
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 Early Development Program Lead will serve as the scientific and operational leader for early-stage drug development programs, bridging discovery and development functions. They will drive cross-functional teams to ensure scientific rigor, strategic alignment, and the successful delivery of program milestones from lead optimization through IND.
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 Associate Director, Medical Science Liaison will build and maintain professional relationships with healthcare professionals to provide expert medical and scientific support. They are responsible for conducting scientific exchanges, presenting product data, gathering customer insights, and supporting clinical development initiatives.
The Associate Director, Medical Science Liaison will build and maintain professional relationships with healthcare professionals to provide expert medical and scientific support for Insmed's therapeutic areas. Key duties include conducting scientific exchanges, presenting product data, supporting advisory boards, and assisting with clinical trial activities.
The Associate Director, 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 HCP insights, and supporting clinical trial activities in alignment with medical affairs plans.
The Therapeutic Specialist will develop and execute sales plans to maximize growth within the rare disease market while maintaining deep knowledge of the competitive landscape. They will collaborate with cross-functional partners and engage with healthcare professionals to achieve shared business objectives in a compliant manner.
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 Associate Director will develop and maintain commercial forecasting models for the respiratory portfolio to inform critical business decisions. They will collaborate with cross-functional teams to integrate market insights and deliver clear, data-driven narratives to senior leadership.
The manager will oversee business operations, financial management, and outsourcing strategy for the Drug Safety & Pharmacovigilance department. They are responsible for managing vendor relationships, negotiating contracts, and ensuring compliance with performance standards.
The Early Development Program Lead serves as the scientific and operational leader for early-stage drug development programs, bridging discovery and development functions. They are responsible for driving cross-functional teams, managing project strategy from lead optimization through IND, and ensuring scientific rigor and on-time milestone delivery.
The Early Development Program Lead will serve as the scientific and operational leader for early-stage biologic drug discovery programs, driving cross-functional teams from target identification through candidate nomination. This role involves managing integrated project plans, budgets, and timelines while ensuring scientific rigor and strategic alignment across research and development functions.
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.
Lead the specialty pharmacy account management function to optimize patient access and operational performance. This includes managing pharmacy relationships, negotiating contracts, and leveraging data insights to drive channel strategy.
Lead end-to-end technology transfer activities from process development to commercial-scale GMP manufacturing for rAAV-based therapies. Serve as a technical bridge between Process Development and external manufacturing partners to ensure process robustness and excellence.
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 Director will drive the medical education grant strategy by overseeing the full lifecycle of grant requests, ensuring compliance with regulatory guidelines and corporate policies. They will also manage budgets, facilitate cross-functional collaboration, and identify educational gaps to support impactful programs for healthcare professionals.
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 Medical Safety Lead serves as the subject matter expert for safety surveillance, risk management, and benefit-risk assessment across the product portfolio. This role involves medical evaluation of adverse events, oversight of safety documentation, and providing expert input into clinical development and regulatory documents.
Lead the development and execution of global regulatory strategies for clinical and lifecycle management activities. Provide regulatory input to cross-functional project teams and act as the primary regulatory contact for the US FDA.
The Senior Director will formulate and implement global regulatory strategies for product development. They will also serve as the primary regulatory contact for the US FDA and oversee regulatory submissions and communications with global health authorities.
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.
This role involves providing clinical input for assessing external in-licensing or acquisition opportunities as part of Due Diligence teams. Additionally, the director will contribute clinical input to cross-functional planning for molecules advancing from internal discovery platforms.
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.
