- Insmed Incorporated (NJ)
- …You'll also: Serve as the therapeutic area lead of the ophthalmology clinical development team , partnering closely with heads of clinical operations, ... Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different diseases and...clinical programs across different diseases and supervise the clinical development team . This individual will be… more
- Insmed Incorporated (San Diego, CA)
- …the Role:We're looking for a Director, Clinical Scientist for the Gene Therapy Clinical Development team to help us expand what's possible for patients with ... Clinical Development, you will support and work predominately with the Clinical Trial/Indication Lead (s) and Medical Monitor(s) for assigned protocols and/or… more
- Insmed Incorporated (NJ)
- …is essential; ability to develop and lead a high performing team across all levelsExperience in multi-functional areas ( Clinical , Regulatory, Quality) ... operations across all clinical programs and plays a key role on the Clinical Supply Chain & Logistics Leadership Team .What You'll Do: Develop, coordinate and… more
- Insmed Incorporated (NJ)
- …competencies.Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead , and clinical study team to ensure ongoing ... within quality, cost, and timeline parameters.Effectively manages and/or assists with cross-functional clinical study team and team members to achieve… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act… more
- Insmed Incorporated (NJ)
- …data. You will develop collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development, Advocacy, Commercial and ... for a Director, Scientific Communications on the Medical Strategy and Communications team to help us expand what's possible for patients with serious diseases.… more
- Insmed Incorporated (NJ)
- …regulatory guidelines will be essential to your success.You will also build and lead a high-performing CMC team while managing relationships with external ... diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for...for the company's small molecule pipeline. As a senior leader , you will oversee drug substance and drug product… more
- Insmed Incorporated (NJ)
- …integrity, accountability, and the pursuit of excellence. You'll have the opportunity to lead a team that safeguards not only technology-but also the trust ... in everything we do. We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and...threats, and key initiatives to the CIO, IT Leadership Team , and, as needed, the Executive Committee and Board… more
- Insmed Incorporated (NJ)
- …values and ethical standards.Must have excellent leadership skills; should be an effective team leader with a track record of successfully developing and ... 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… more
- Insmed Incorporated (NJ)
- …patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead our gene therapy and large molecules pipeline from preclinical through ... clinical development and regulatory approvals. In this role you...be a key member of the Technical Operations leadership team and play a critical role in shaping strategy,… 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 ... and long-term adoption. This role is focused on the US market.This leader will focus on driving HCP engagement, advancing scientific education, and developing… more
- Insmed Incorporated (NJ)
- …the evidence requirements to support product value proposition, access, and reimbursement. Lead HEOR team responsibilities for research strategy development and ... in. Are you?About the Role:The Senior Director, HEOR is a strategic leader responsible for the development and execution HEOR strategies and evidence generation… more
- Insmed Incorporated (NJ)
- … clinical documentation; serves as the medical writing point of contact for clinical study teams. May serve as the lead Medical Writer.Applies in-depth ... to protocols and protocol amendments, Investigator's Brochures (IBs) and IB updates, clinical study reports (CSRs), Clinical Summary Modules for Regulatory… 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 ... and long-term adoption. This role is focused on the US market.This leader will focus on driving HCP engagement, advancing scientific education, and developing… 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)
- …computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical /Manufacturing systems.Project lead experience preferred.Strong experience in ... the Role: \tEngage on CSV Projects as a key team member. Provide guidance and support to ensure Insmed...regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software… more
- Insmed Incorporated (San Diego, CA)
- …and lead validation activities with internal stakeholders and project team members. Author CSV Documents (Validation Plans and Summary Reports) Assist/co-author ... the Role: \tEngage on GxP Projects as a key team member. \tProvide guidance and support to ensure Insmed...on site Change Control CAB meetings as the CSV lead . Who You Are: Position Requirements (Required and/or Preferred… 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 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)
- …of the Global Supply Chain & Logistics - Supplier Relationship Management team supporting the Technical Operations organization. The role will partner closely with ... Commercial and Clinical Supply Chain with responsibilities including supplier governance management,...collaborator, self-motivated, and able to problem-solve to influence and lead work groups. This position reports to the Director,… more
