15 senior manager scientific communications jobs found in Waltham

Alkermes, Inc. The Senior Product Manager, HCP Marketing is responsible for contributing to marketing strategies across HCP stakeholders in multiple care settings for Aristada, an established brand. He/she will report to the Director of HCP Marketing and will be responsible for developing and implementing strategic and tactical marketing programs supporting Aristada. 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: Contributing to brand marketing strategies and plans, including opportunity identification, key messages and promotional activities that increase demand across settings of care. Develop supporting measurement plans that demonstrate impact of programs on the business Developing strategic and tactical resources and gain alignment across broad brand team and salesforce Development...

Alkermes, Inc. Alkermes is seeking an experienced Program Manager to support our ALKS 2680 program which is currently in Phase 2 development and preparing for Phase 3 and registration. ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy and idiopathic hypersomnia. This person will work closely with members across our organization including areas such as research, pre-clinical, clinical, pharmaceutical development, regulatory affairs, medical affairs, commercial, operations, policy and government affairs, patient engagement and corporate communications, as well as the senior management team to orchestrate development and execution of our fully-integrated program strategic and operational plans to support key corporate goals including the development and ultimate approval of ALKS 2680 as well as identify and execute a comprehensive lifecycle management program. This is a hybrid on-site...

Creative Circle Senior UX Designer (with Pharma/Life Sciences experience!) Location: Waltham, MA (West End neighborhood - not easily T accessible) On-Site Requirement: Hybrid - 3 days per week Duration & Hours: 6 months, 40 hours per week Rate Range: $50-$60 per hour (W2) Job Description: Our client, a digital engineering firm, is seeking a Senior UX Designer with to partner with their client based in Waltham, MA. This will be a long-term, hybrid Senior UX Designer role supporting a leading life sciences client in designing a next-generation internal portal for laboratory automation and drug discovery workflows. The role is 40 hours per week, onsite at least 3 days per week in Waltham, MA, and begins as a 6-month freelance contract with potential extension. You will lead user research, shape the information architecture and interaction design, and collaborate closely with cross-functional teams, including scientific staff, content leads, creatives, and a...

Alkermes, Inc. We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a 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 serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong scientific background, broad experience developing drugs, and the ability to leverage that experience to impact program teams beyond regulatory strategy. This role reports to the Executive Director, Regulatory Strategy. Responsibilities Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams Develop and implement global regulatory strategies for pipeline drug...

Alkermes, Inc. The Executive Director, Enterprise Data Management is responsible for leading and expanding enterprise data management capabilities that support all functions-with an initial focus on R&D and Commercial. This role will drive the continued development and execution of the company's enterprise data strategy, strengthen data governance, oversee data acquisition and master data management (MDM), scale data operations, and accelerate the delivery of data solutions that meet key business needs and support AI / analytics / reporting solutions. This role will lead several teams of data professionals, including an existing Commercial Data Management team, a new R&D Data Management team, and a new Enterprise Data Governance specialist. Depending on start date, this position will lead the hiring of new positions for R&D Data Management and Enterprise Data Governance. This role will work a weekly hybrid schedule in our Waltham office. This role will report 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. 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...

Alkermes, Inc. Associate Director, External Operations API API process expert responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations' (CMO's) and subsequent processing of API's in Drug Product (DP) processes across OSD and injectables. Required to support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO's on behalf of Alkermes. Responsibilities General Review and maintain Alkermes practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements - ensuring that appropriate policies, rules, regulations and agreements are followed. Understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities. Perform trending on CMO API processes and identify...

Alkermes, Inc. The primary responsibilities of an Associate Director in the Nonclinical Safety Evaluation (NSE) organization are to (1) design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes' diverse small molecule drug candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director is the single point of accountability within NSE for all strategic, scientific, study-related, and regulatory aspects of the programs he/she manages. The Associate Director in NSE has a broad understanding of toxicology and regulatory requirements to progress candidates through clinical development and is recognized by internal peers for his/her scientific contributions and deliverables (within discipline) to Discovery and Development programs. The individual has specific expertise in one or more areas relevant to nonclinical safety evaluation, shows competency in all aspects,...

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...

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...

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. 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...

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 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. 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...