9 project manager jobs found in Waltham

CSL CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional Position Purpose Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties. Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products. Review, approve, or reject promotional...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary: Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk assessment and decision...

CSL The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. ( Positions available supporting multiple Therapeutic Areas available ) Main Responsibilities: Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents....

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will be part of a specialized non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding of assay design, regulatory...

CSL Associate Director, Corporate & External Affairs, R&D Portfolio Position Purpose: The Associate Director, Corporate and External Affairs, R&D Portfolio will lead corporate and external affairs strategy for CSL's pipeline. The successful candidate will be responsible for driving communications for key pipeline milestones and clinical trials. They will serve as a strategic partner on R&D policy. They will lead issues and crisis management related to pipeline. In addition, they will strengthen the company's reputation within the Waltham biotech ecosystem and US to enhance and protect CSL's reputation and policy position. Reporting Relationships: Reports to: Head of Corporate and External Affairs, R&D Direct reports to position: 1 Main Responsibilities and Accountabilities: Serve as primary business partner and strategic advisor to SVP, Portfolio Development, SVP, GRAS and VP, Portfolio and Operations Excellence to shape...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. Position Description Summary: You will be part of a specialized non-laboratory-based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Principal Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables Main Responsibilities: Input to statistical strategy and ensure appropriate statistical methodologies applied...

CSL The Position: The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities. Responsibilities: Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics Identify disruptive technologies and...