12 safety lead jobs found in Waltham

Alkermes, Inc. The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives. Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently...

Alkermes, Inc. The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Director will also serve in a visible role in providing safety leadership and advisement in several company-wide forums and initiatives. The successful candidate will have demonstrated prior career success as a product safety physician and managing/ developing individuals and highly effective teams. This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to...

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 Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three...

National Grid About us Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. National Grid is hiring a Lead Project Manager, Capital Project Delivery for Massachusetts. This is a Onsite Role - Must live within a commutable distance to Waltham, MA. Job Purpose The New England Electric Major Projects team drives project management for major electric capital construction project investments, leading the clean energy transformation and significant portfolio growth. Projects include multi-year complex, large-scale Transmission-Line projects. The dedicated Lead Project Manager will oversee and drive major electric capital construction projects, ensuring safe delivery within budget, schedule and scope. Key Accountabilities * Lead strategic, critical, and complex electric capital construction...

Alkermes, Inc. Reporting directly to the Head of Medical Affairs, the VP, Head of Life Cycle Management (LCM) is a highly visible and business-critical role at Alkermes. This role is tasked with understanding the business strategies and drivers underlying our medicines for the treatment of serious mental illness, sleep disorders and our emerging neuroscience pipeline and translating those drivers into data generation plans across our programs and disease areas of interest. This individual will need to effectively collaborate and communicate with colleagues within Medical Affairs and key cross-functional partners (e.g., Commercial, Clinical Development, Clinical Operations, Regulatory Affairs, Safety, Biostatistics, Program Management, Government Affairs, Business Development), and frequently represent the function to senior management and the company to healthcare professionals. This position is based in Waltham, MA. Responsibilities Lead the efforts to collaborate with...

Alkermes, Inc. This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources. This position must be able to quickly identify critical and high risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues. Travel requirement of 40% - 60% Responsibilities This position will : Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: Audits of clinical vendors, clinical sites...

National Grid The Opportunity Every day, we deliver safe and secure energy to homes, communities, and businesses, connecting people to the energy they need for their lives. Our expertise and track record position us uniquely to shape the sustainable future of our industry as the pace of change accelerates. To succeed, we must anticipate customer needs, reduce energy delivery costs, and pioneer flexible energy systems. This requires delivering on our promises and seeking opportunities for growth. In IT & Digital, we collaborate closely with the diverse energy businesses within the National Grid group, revolutionizing operations through technology. Embracing modern methodologies and Digital mindsets, we drive efficiency and bring new capabilities to internal and external customers as we lead the charge toward a carbon-free future. Our work is critical, as National Grid powers millions of homes and businesses in the UK and US, and the technology we employ is vital to this...

CSL Job Description 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 Director of Clinical Program, Immunoglobulins ? The job is in our King of Prussia, PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will be a critical role within Clinical Development. You are accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). The GCPL is accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is...

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. Your role The incumbent will be responsible for the quality and delivery of high-quality clinical development documents and oversight of clinical study delivery across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group. Your responsibilities will include Oversight of Individuals Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific...

Alkermes, Inc. Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary. Responsibilities Acts as point of contact for cross-functional teams on local and global labeling issues. Manages labeling development or approval. Preparation of updated Core Data Sheets and US...

National Grid About us Superpowered. Meaningful work. Human impact. A story we're proud to tell. This is what matters to us at National Grid. In a world of complexity and unanswered questions, there is one thing we're certain about: the power of our people. National Grid is hiring a Principal Project Manager (Electricity), Capital Project Delivery for Massachusetts. This is a Onsite Role - Must live within a commutable distance to Waltham, MA. Job Purpose The New England Electric Major Projects team drives project management for major electric capital constructionproject investments, leading the clean energy transformation and significant portfolio growth. Projects includemulti-year complex, large-scale Transmission-Line, Distribution-Line and Substation construction projects along with High Voltage DirectCurrent (HVDC) construction. The dedicated Principal Project Manager will oversee and drive major electric capitalconstruction projects, ensuring safe delivery...