13 development data coordinator jobs found in Waltham

Alkermes, Inc. We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Associate Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will provide strategic and tactical advice to teams to achieve support the development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. The ideal candidate will have a strong scientific background, and be able to leverage their experience to provide leadership within the department and across R&D. This role reports to the Senior Director, Head of Orexin Regulatory Strategy. Responsibilities Contribute to development of robust, global regulatory strategies for assigned projects. Accountable for adapting and maintaining the regulatory strategy as needed Develop submission plans and...

National Grid About us National Grid is hiring a Manager, NE Electric Field Safety for our NE Safety, Health, and Wellbeing team in Waltham, MA (Reporting base is flexible). Must live within a commutable distance to one of our Electric facilities. Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they live. The pace of change in society and our industry is accelerating and our expertise and track record puts us in an unparalleled position to shape the sustainable future of our industry. To be successful we must anticipate the needs of our customers, reducing the cost of energy delivery today and pioneering the flexible energy systems of tomorrow. This requires us to deliver on our promises and always look for new opportunities to grow, both ourselves and our business. Job Purpose This role is responsible for leadership and development...

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 Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines, budget, and quality standards, and according to the TA strategies. This role must be experienced in working in a matrix...

Repligen Overview The HR Communications Intern will support the Human Resources team by assisting with change management and internal communication initiatives that help employees understand, adopt, and engage with key organizational and HR programs. Based in Waltham, this intern will work closely with HR partners to help translate complex change impacts into clear, timely, and consistent messaging. This role provides hands-on exposure to enterprise HR initiatives and offers an opportunity to contribute meaningfully to employee engagement and adoption efforts. Responsibilities Support change management initiatives by assisting in the development and delivery of internal communications related to HR and organizational programs. Help translate the impact of change initiatives-such as Workday, learning & development opportunities, and talent management programs-into clear, employeefriendly messaging. Assist in ensuring consistent communication across HR and...

Alkermes, Inc. We're looking for a strategic, technically sharp leader to take ownership of Alkermes' cloud and Linux platform ecosystem. This role sits at the center of our enterprise and R&D technology landscape and is responsible for the performance, reliability, and compliance of our AWS workloads and Linux compute environments across both cloud and onprem systems. You'll bring deep platform engineering experience plus the ability to steer a modern managedservices model. You'll shape how our cloud and Linux platforms evolve - partnering closely with Enterprise Architecture, Cloud Architects, and IT Functional Leads - ensuring our environments remain scalable, secure, compliant, and ready for the scientific and business demands ahead. In this role, you'll set the technical direction, guide engineering approaches, and ensure our platforms run with strong operational discipline. Your work will directly support scientific computing, enterprise workloads, and the broader...

Alkermes, Inc. The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for assigned marketed and/or investigational product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Senior PV Scientist also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and...

CSL Job description Senior Director Clinical Program Lead CVR You will be 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). You are also accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is responsible for: the timely development and execution of the Clinical Development Plan (CDP). managing the day-to-day operations of the CDT including but not limited to meeting coordination and documentation, decision making, and stakeholder management. ensuring that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations. This position is accountable for the clinical & scientific oversight of the assigned program(s) and: ensures high quality clinical & scientific standards are met during all aspects of the program providing...

Alkermes, Inc. As a Project Manager, you will support Alkermes in advancing a comprehensive AI strategy through our INDIGO program, an enterprise-wide initiative to expand the impact of machine learning and AI capabilities across our business. Your role will involve leading cross-functional projects supporting the R&D AI workstream within INDIGO and partnering closely with the INDIGO Program Manager to further establish the team's agile transformation. By aligning outcomes and processes with strategic goals and ensuring that projects are delivered on time and in budget, you will be pivotal in contributing to best practices, shaping INDIGO operations, and ensuring successful outcomes on Alkermes' investments in ML and AI technologies and products. Competitive candidates must demonstrate strengths in collaboration, organization, problem solving, facilitation, communication, and thrive in a fast paced environment. They bring deep experience in agile project management,...

Alkermes, Inc. The Executive Director, IT R&D will oversee an IT organization that drives the standard and compliant delivery of IT R&D support and services. Key objectives for this role will be to establish technology delivery standards for the R&D function based on business need. The role will be responsible to plan, direct, and manage the IT solutions for Clinical, Drug Safety, Regulatory, Medical Affairs and the Research and Development areas within Alkermes and provide leadership and knowledge empowerment for team members and mature the IT R&D services within the company. This role will be a key member of the IT Senior Leadership Team and will be the primary liaison between various internal and external IT organizations and the previously mentioned Alkermes functional areas. This position will report to the Chief Information Officer (CIO). This role will work a weekly hybrid office schedule in our Waltham location. Responsibilities Job...

Alkermes, Inc. In this leadership position, the Senior Director, Statistical Programming will serve as the head of statistical programming who oversees all statistical programming activities to support Alkermes' growing portfolio. This leader will provide guidance on statistical programming technical skills, selecting appropriate and innovative approaches to produce high quality deliverables for in-house and outsourced projects. This role will manage hiring, resource planning and setting strategic vision for the statistical programming group as well as assist on complex deliverables. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work Duties and Responsibilities: Develop and lead a team of high performing statistical programmers to meet corporate regulatory, scientific, and business objectives. Deliveries of the statistical...

Alkermes, Inc. This is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes's clinical development portfolio in Neurology. Specifically, this position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for Neurology indications, including neurogenerative and sleep disorders. The Vice President will drive the strategies and clinical plans across all phases of drug development. Key domains include development of study protocols, medical review of clinical trial data and generation of clinical study reports. The Vice President will interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory,...

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...

Alkermes, Inc. This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical responsibilities in the clinical department involved in the development of therapies for neurology and neuropsychiatric indications, including sleep disorders. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the Medical Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project...