- Insmed Incorporated (San Diego, CA)
- …compliance related to GCPs, acts as quality lead on the gene therapy clinical development team , and collaborates on other related activities performed by ... Are you?About the Role:Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ...respectful manner that is conducive to goal achievement and team building.Must be able to prioritize work effectively to… more
- Insmed Incorporated (NJ)
- …and community physicians.Partner with Medical Affairs to ensure scientific and clinical insights inform HCP strategies. Lead development and implementation of ... be responsible for building and developing a high-performing brand team .What You'll Do: Key ResponsibilitiesHCP Marketing Strategy DevelopmentDevelop the… more
- Insmed Incorporated (San Diego, CA)
- …data integrity, system reliability, and regulatory compliance across all phases of clinical development. Team Leadership & Collaboration: Mentor and guide junior ... Are you?About the Role:The Associate Director, EDC Programming will lead and oversee EDC programming, and database build for...and oversee EDC programming, and database build for in-house clinical trials. This role will be responsible for the… more
- Insmed Incorporated (NJ)
- …the external medical community.What You'll Do: Leadership role within a cross functional team of medical professionals in planning and driving all aspects of the ... of Phase 4 company sponsored studies, including HEOR studies and registries. Lead and execute on innovative omnichannel medial education.Provide medical expertise… more
- Insmed Incorporated (NJ)
- …Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP ... deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team , Regulatory, Clinical Operations, and Program Management… more
- Insmed Incorporated (NJ)
- …experience required. Ability to set a vision and plan for a field medical team .Advanced science / clinical degree, from an accredited institution, (PharmD, MD, ... of the Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Medical Science Liaison (MSL) team members and any Regional Directors in support of the execution of all… more
- Insmed Incorporated (NJ)
- …science, we're in. Are you?About the Role:The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational and marketed products ... VP, DSPV and may serve as delegate during his absence.What You'll Do: Lead the DSPV Medical Safety Strategy and Benefit-Risk Management group providing strategic… more
- Insmed Incorporated (NJ)
- …treating HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical and research insights inform HCP strategies. Lead development and ... be responsible for building and developing a high-performing brand team .What You'll Do: Key ResponsibilitiesHCP Marketing Strategy DevelopmentDevelop the… more
- Insmed Incorporated (San Diego, CA)
- …within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability ... to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program… more
- Insmed Incorporated (NJ)
- …a matrixed organization.Previous leadership experience in medical affairs and ability to lead by influence within a matrixed team .Global experience or experience ... Role:The Medical Director, Medical Affairs - Pulmonology will develop, implement, and lead the indication strategy and planning for Medical Affairs across all… more
- Insmed Incorporated (NJ)
- …the evidence requirements to support product value proposition, access, and reimbursement. Lead HEOR team responsibilities for research strategy development and ... across the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's business needs. This is… more
- Insmed Incorporated (NJ)
- …ensuring One Medical voice. As a core leader within the brand medical strategy team (Medical Strategy Lead , Publications Lead , Scientific Communications ... to external HCPs.Ensure strategic alignment of scientific communications across all channels. Lead continuous adaptation to evolving clinical practices and… more
- Insmed Incorporated (NJ)
- …of clinical trials, and interacts with cross-functional teams.What You'll Do: Lead complex clinical trials or indication corresponding to one or several ... Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line. This role leads the protocol… more
- Insmed Incorporated (NJ)
- …and timely completion and hand-off to routine commercial manufacture.What You'll Do: Lead project teams for Technical Operations activities, both within Insmed and ... with external contractors. Lead the transition of projects from Research into Technical...Assurance, and Regulatory, with input from Commercial, Research, and Clinical .Prepare and manage detailed project plans and drive them… more
- Insmed Incorporated (NJ)
- …Role:The Medical Director for Interstitial Lung Diseases will develop, implement, and lead the therapy portfolio strategy and planning for Medical Affairs across all ... geographic regions ensuring a cohesive approach. This role will develop and lead all medical affairs activities ensuring partnership within the team (medical… more
- Insmed Incorporated (NJ)
- …the Role:The Manager, Programming will provide statistical programming and analytic support clinical studies. As a team member of the Programming function, ... Programming will be working interactively with functional colleagues from Biostatistics, Clinical Operations, Data Management and Project Management, as well as… more
- Insmed Incorporated (NJ)
- …the Role:Insmed is seeking a talented and motivated AD, Packaging Engineer to join our team at our Bridgewater, NJ headquarters. This is a hybrid role that offers a ... and optimizing packaging solutions for our innovative drug products. You will lead packaging development projects from concept to implementation, ensuring that our… more
- Insmed Incorporated (NJ)
- …methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging a ... and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working… more
- Insmed Incorporated (NJ)
- …cross-functional teams to ensure seamless execution of QC deliverables in support of clinical and commercial programs. A key aspect of this role involves managing ... on inhalation-specific testing (eg, APSD, MMAD, delivered dose, particle size distribution). Lead and approve deviation investigations, OOS, and OOT results generated… more
- Insmed Incorporated (NJ)
- …role, the candidate will be responsible and accountable for creating a best-in-class team to plan, integrate and lead activities associated with moving Insmed's ... late-stage pipeline through clinical development, regulatory submissions and commercial launch. This position...launch. This position will be accountable to ensure all team members are providing the appropriate level of strategic… more
