16 director advanced markets jobs found in Waltham

Alkermes, Inc. Position: Senior Director, New Product Planning (NPP) - Neuroscience This position offers a candidate the opportunity to significantly contribute to the long-term commercial success of the portfolio. This position is responsible for leading clinical development stage programs towards commercial success through market assessments and effective interactions across multiple functions. This is role will work a hybrid weekly office schedule in our Waltham location. Responsibilities Key Responsibilities: Lead development of forward-looking strategies, market positioning and product profiles for neuroscience pipeline products by synthesizing primary and secondary inputs that inform the development and lifecycle plan Co-lead (with development colleague) product teams through clinical development phases, working in conjunction with internal business partners (e.g. clinical, translational medicine, regulatory, research, commercial, CMC) to optimize the market...

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 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. 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...

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! A fast-growing and acquisitive global public company is looking for a strong, experienced, and detail-oriented Senior Director of Finance reporting directly to the Vice President of FP&A. This represents an opportunity to work in a key finance leadership role with significant levels of executive visibility. This role must pay great attention to detail, deliver results, and operate cross-functionally in a rapidly changing environment. This role is a critical business...

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...

Alkermes, Inc. The Senior Director is responsible for developing and implementing strategies and programs to ensure the successful commercialization of ARISTADA and ARISTADA INITIO, part of the Alkermes Psychiatry Franchise. The Senior Director will serve as the marketing lead for ARISTADA, driving brand positioning and messaging and guiding the organization in identifying HCP and patient needs, as well as the brand lead for the ARISTADA program team. This is a Hybrid position, based in Waltham, MA. Responsibilities Strategy & Execution Serve as the marketing lead for ARISTADA, responsible for strategic planning, tactical execution, and cross-functional alignment throughout the product lifecycle across HCPs, patients, and treatment settings to achieve optimal market performance. Collaborate closely with field-based community and hospital teams to ensure prescription and prescriber growth across all treatment settings (CMHC, office, hospital). Work closely with...

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. Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. This individual will be responsible for providing strategic regulatory direction and managing CMC related activities in close partnership with cross-functional development teams, ensuring compliance with global regulatory standards and alignment with internal program goals. This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work. Key Responsibilities: Lead...

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...

Alkermes, Inc. The role is a key member of the Sales & Marketing Analytics team, responsible for providing analytical support and transforming digital marketing data into actionable insights for a growing commercial organization. This role collaborates with internal stakeholders and external vendors to extract meaningful insights from data for Brand Marketing team and Customer Experience Marketing team. This role reports to the Associate Director, Sales & Marketing Analytics and work at hybrid schedule in our Waltham, MA location. Responsibilities Key Responsibilities: Support brand marketing and customer experience marketing teams on strategic initiatives. Analyze marketing performance and customer engagement across digital channels, including digital media, email, and television. Track key performance indicators (KPIs) and deliver insights to optimize marketing campaigns. Develop and maintain dashboards and self-service data visualizations using business...

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:...

Alkermes, Inc. We are seeking a highly motivated and strategic individual for a Director of Health Economics and Outcomes Research (HEOR) role at Alkermes. This is an exciting, visible, and highly collaborative opportunity where you will play a pivotal role in executing on evidence generation plans in support of Alkermes' most advanced pipeline program in sleep-wake disorders. You will report to and support the Head of HEOR in the delivery of research activities and development of materials to support engagements with key stakeholders, including physicians, regulatory agencies, reimbursement bodies, and patients/advocates. The ideal candidate will have a strong technical background in HEOR, excellent data science and visualization skills, great written and verbal communication skills, and a proven ability to foster and manage internal and external relationships effectively. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees...

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. As a product and disease state expert within Medical Affairs, the Associate Director, Scientific Communications will provide medical, scientific and technical expertise to scientific communications deliverables for marketed and pipeline products. They will help develop, manage and track scientific communication plans as well as create and review deliverables for medical and scientific accuracy. The Associate Director will ensure compliance with Alkermes policies, procedures, and best-practices and support the development of key product materials for marketed and pipeline products. 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. Major Accountabilities: Act as the Medical Communications lead for product-specific working groups or projects and support Publications, as needed Support other Scientific...