33 director data strategy jobs found in Waltham

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...

Alkermes, Inc. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for...

Alkermes, Inc. We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams. This position will have a core scientific responsibility of selecting optimal doses and dosage regimens in patients, and will integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role will provide the opportunity to support multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable. Essential Areas of Responsibility: Contributing to clinical program design, trial protocols,...

Alkermes, Inc. The Associate Director of Consumer Marketing will be responsible for developing and implementing tactical marketing programs, primarily for consumers and caregivers, supporting the bipolar 1 disorder and schizophrenia indications of LYBALVI. This includes Direct-to-Consumer (DTC) strategy, media plan, content development, and analysis. The position requires an experienced and highly motivated individual with strong strategic and leadership capabilities. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. Responsibilities Key Responsibilities: Manages the execution of consumer promotional campaigns for LYBALVI Crafts actionable assignment briefs for creative agencies Manages the development of the consumer media plan, channel allocation, targeting and measurement required to deliver on business and...

Alkermes, Inc. Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases IIV of development. Responsibilities Clinical project team member: works closely with the Sr. CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation,...

CSL The AI/ML Advanced Analytics, Automation & Digital Agent CoE Lead is responsible for shaping and executing the AI and automation strategy across R&D. This role integrates advanced analytics, machine learning, intelligent automation, and digital agents to drive scientific and operational excellence. The leader oversees capability building, governance, technical standards, and external engagement to deliver innovation at scale while ensuring compliance and measurable business value. Main Responsibilities & Accountabilities *Define and implement integrated AI/ML and automation strategy across R&D, aligned with business priorities.*Oversee development and deployment of advanced analytics models, automation tools, and digital agents to streamline R&D processes.*Lead governance and establish standards for responsible AI, ML Ops, and automation toolkits.*Collaborate with internal stakeholders (e.g., Digital Business Partners, I&T, lab owners) and...

Alkermes, Inc. We are seeking a highly motivated, experienced hands-on Associate Director of Information Security (Cloud and Emerging Technology) to take a leadership role in shaping and executing the organizations security strategy in advanced technologies. Reporting to the Director of Information Security, this position will oversee a small team of security professionals and act as a trusted advisor across IT, and business units. This role will be responsible for developing, implementing, and enforcing security frameworks and guardrails for cloud environments (primarily AWS), AI/ML platforms, Large Language Models (LLMs), and DevSecOps practices. In this role, the Associate Director will lead efforts to secure cloud and emerging technologies, ensuring compliance with regulatory requirements and alignment with organizational risk appetite. Responsibilities Essential Duties and Responsibilities Lead, mentor, and manage a small team of security professionals, fostering...

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 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 Responsible for the strategy, development, and optimization of digital platforms that support external innovation, business development, market analysis, and competitive intelligence. This role ensures the organization has a strategic edge by enabling timely, accurate, and actionable insights from external data sources, partnerships, and market signals. Main Responsibilities & Accountabilities *Lead the design and evolution of search and intelligence platforms that aggregate and analyze data from scientific literature, patents, clinical trials, market databases, and competitor pipelines*Collaborate with business development, R&D, strategy, and digital teams to define platform requirements, use cases, and key performance indicators (KPIs)*Integrate AI/ML, NLP, and semantic search technologies to enhance discovery, relevance, and insight generation*Manage external vendors and data providers, ensuring high-quality service delivery, innovation, and...

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...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! We are seeking an experienced and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role in aligning technology initiatives with business goals, driving efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with business leaders and IT colleagues to evaluate,...

Alkermes, Inc. Associate Director of Information Security We are seeking a highly motivated, hands-on Information Security leader with strong, broad security expertise and proven experience in Data Loss Prevention (DLP) and Data Security Posture Management (DSPM), to join our team as an Associate Director of Information Security . This is a senior technical role that combines strategic leadership with technical execution to protect sensitive data across complex environments. In addition, this role will also oversee the Information Security Third-Party Risk Management (TPRM) program, ensuring robust security practices across internal and external environments. The Associate Director will lead a small team of security professionals and will report to the Director of Information Security. Responsibilities Essential Duties and Responsibilities Lead, mentor, and manage a team of security analysts, fostering a culture of continuous improvement, accountability, and...

Alkermes, Inc. Director - Commercial Master Data Management The Director, Commercial Master Data Management will be responsible for establishing key Master Data assets (including Customer) as trusted sources of truth and ensuring appropriate use of Master Data by the Commercial organization. This position will define and lead Master Data Management (MDM) strategy, MDM governance, MDM capability development / enhancement, MDM operations, and Master Data integration with other data and systems in the Commercial infrastructure. This position will play a key role in the Data, Analytics & Insights organization reporting to the Head of Commercial Data Management and will lead a team of internal and external data stewards and MDM system analysts and developers. The ideal candidate should have extensive knowledge in Pharma Commercial MDM solutions and Customer/Payer/Product Master Data, understand downstream business impact, and have the ability to advocate, adopt, and lead the...

Alkermes, Inc. The Associate Director, Competitive Intelligence (CI) will be part of a growing innovative team responsible for delivering actionable competitive insights to support strategic decision-making for both inline products and a late-stage pipeline asset. The Associate Director will partner closely with cross-functional teams, including Commercial, Medical, and R&D to reduce decision risk, and inform portfolio and product strategy. This role will be based in our Waltham office and work a Hybrid office schedule. Responsibilities Responsibilities: CI for Inline Products Monitor and analyze competitor activities and anticipate market shifts (e.g., marketing, pricing, clinical data, regulatory changes) to assess impact on company's commercial portfolio. Develop and maintain competitor profiles to support commercial teams and field force Deliver regular updates and alerts to stakeholders on market dynamics, competitor tactics, and threats/opportunities....

Alkermes, Inc. The Customer Experience Effectiveness Lead is responsible for establishing measurement frameworks and defining and operationalizing key performance indicators (KPIs) for omnichannel customer engagement across healthcare professionals (HCPs) and consumers. As a strategic partner to the Customer Experience and Brand Marketing teams, this role bridges marketing, measurement, and data operations to ensure customer experiences are measurable, scalable, and continuously optimized. Responsibilities include defining what "good" looks like, establishing a robust tracking framework, ensuring insights are actionable and embedded in decision-making, and supporting the development of processes and testing strategies to drive ongoing improvement based on learnings. Alkermes has adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. Responsibilities...

Alkermes, Inc. The Customer Experience Marketer is a strategic partner to the Brand Marketing team, responsible for defining the customer experience strategy and designing tactical omnichannel marketing plans across multiple audiences, including healthcare professionals (HCPs) and consumers. This role combines a deep understanding of omnichannel marketing with strong cross-functional collaboration skills to design and optimize data-driven, insight-led customer experiences that align with brand strategy and drive business growth. This role will also be responsible for advancing omnichannel orchestration capabilities across the organization by leading cross-functional initiatives and educating stakeholders on tools and best practices. Alkermes has adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. Responsibilities Key Responsibilities:...