25 design jobs found in Waltham

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...

Alkermes, Inc. The Neurobiology Group is seeking a skilled candidate to participate in an internship (8 - 12 weeks) to assist with our drug discovery and assay development efforts. The selected candidate will independently conduct lab-based behavioral neuroscience research utilizing in vivo rodent behavior models. The goal of this paid internship is to provide an entry-level scientist with the opportunity to learn and take part in drug discovery research. The intern will operate both autonomously and as part of a multi-disciplinary team to execute an independent project, gaining proficiency in advanced experimental methodologies and theoretical frameworks pertaining to CNS disorders. The project encompasses various facets of in vivo research, such as animal handling and dosing, necropsy, assay development and validation, as well as statistical analysis. Primary responsibilities include daily management and care of laboratory animals, routine execution of rodent behavioral...

Alkermes, Inc. Alkermes is seeking a summer intern for the Pharmaceutical Chemistry group in Waltham, MA. The candidate will support drug development activities with a focus on nano-milling. The candidate will design and execute experiments, analyze resulting materials, process data and document procedures in an electronic laboratory notebook. During this internship the candidate will learn about the drug development process, enhance their laboratory skills, and gain experience in data analysis, collation and presentation. Responsibilities The major responsibilities of this internship are: Conduct experiments and record in an electronic laboratory notebook Analyze data collected from experiments and present results to manager Develop and document best practices for experiments Create a final presentation to present to the department at the end of the internship Qualifications Basic Qualifications: Candidate should be pursuing an undergraduate degree in...

Alkermes, Inc. Alkermes has an exciting opportunity for a talented scientist to join our Research Organization as a Director to help lead medicinal chemistry efforts from target ideation through to candidate nomination for neurological disease indications. The desired candidate will be a recognized expert in successfully initiating and managing the medicinal chemistry activities inside a given portfolio and will play a key strategic role in shaping discovery direction and compound design strategy. The candidate will have a proven track record of utilizing structure-based drug design (SBDD) to rationally design compounds that have progressed to candidate delivery. Additionally, the candidate must have direct experience of working with both internal and external partners (e.g., CROs) to facilitate medicinal chemistry activities. Exceptional cross-functional communication skills as well as experience in leading drug discovery teams are necessary attributes. Responsibilities...

Alkermes, Inc. The Sr. Manager position within Clinical Supply Chain leads end-to-end supply chain management on multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as the key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel leading supply activities for complex programs that may require multinational interactions. In addition, they coordinate and lead supply activities with both internal and external partners. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs. Responsibilities Prepare, update and monitor program budgets and ensure financial Key Performance Indicators (KPIs) and relevant cost saving targets Proactively lead clinical program supply strategy ensuring trial design, enrollment timeline, manufacturing availability and...

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...

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...

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...

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. Alkermes is seeking a highly motivated Summer Intern to join the Molecular and Cellular Pharmacology (MCP) group within the Research Organization during Summer 2026. This is a hands-on, laboratory-based internship designed for students interested in gaining practical experience in in vitro pharmacology and smallmolecule drug discovery, with an emphasis on CNS therapeutic areas. The intern will work closely with experienced scientist to support biochemical and cellular assay development, execution, data analysis. This role provides exposure to modern platebased assay technologies, automation, and collaborative drug discovery research in an industry setting. Qualifications Basic Qualifications: Currently enrolled in a B.S. or M.S. or PhD program in biochemistry, cell biology, pharmacology, biomedical sciences, or a related discipline. Coursework or handson laboratory experience in biochemistry, cell biology, pharmacology, or a related field. Preferred...

Alkermes, Inc. The Summer Intern will support the Genomic Sciences and Target Discovery team in strengthening the rigor, efficiency, and scalability of early target assessments through the application of AI/ML methods. This role will focus on building computational frameworks, data and AI-driven workflows that enable real-time competitive intelligence, improved target dossier generation, and systematic target prioritization. The intern will gain hands-on experience at the interface of data science, machine learning, and early discovery research, with opportunities to contribute directly to platform development that informs neuroscience and psychiatric drug discovery. Qualifications Basic Qualifications: Current enrollment in a Master's or Doctoral program in one of the following fields: Computer Science Data Science or Machine Learning Computational Biology Bioinformatics Computational Neuroscience Or a related quantitative discipline Preferred...

Alkermes, Inc. As a chemistry intern, you will have opportunity to learn about the pharmaceutical industry, interact and have exposure to our organizational leaders and their teams. Additionally, you will gain hand on experience in the area of drug candidate synthesis, purification and characterization by working alongside experienced chemists. Responsibilities As a member of the Alkermes medicinal chemistry group, the intern will be responsible for: The synthesis, purification and characterization of molecules in support of a particular research project. She/he will conduct multi-step syntheses, which may include utilization of specialized organic chemistry techniques such as handling air- and moisture-sensitive reagents, solid phase organic synthesis and use of laboratory automation. In addition, the candidate will also investigate new synthetic methodologies described in the literature to help validate these new chemistries for future molecules inside of projects....

Alkermes, Inc. The Summer Intern will work closely with senior biostatisticians on statistical methodology and support for quantitative decision-making implementation in clinical trials. Full time summer internship lasts about 10-12 weeks. Starting time is flexible around May or June 2026. This can be a remote or hybrid internship onsite 3x a week in our Waltham, MA office. Basic Qualifications: Ph.D. candidate who has passed the qualifying exam in biostatistics, statistics, applied mathematics, or data sciences and is not expected to graduate prior to completion of the Summer 2026 internship. Have effective oral and written communication skills. Sufficient programming skills in SAS and/or R /or Python. Preferred Qualifications: Proficient in R and had experience of R Shiny in developing, testing and deploying dashboards about statistical metrics Be able to conduct literature review independently. Experience in the development and application of advanced...

Alkermes, Inc. The Summer Intern will work closely with senior biostatisticians on statistical methodology and support for quantitative decision-making implementation in clinical trials. Full time summer internship lasts about 10-12 weeks. Starting time is flexible around May or June 2026. This role can be remote or hybrid onsite 3x a week in our Waltham, MA office. Basic Qualifications: Ph.D. candidate who has passed the qualifying exam in biostatistics, statistics, applied mathematics, or data sciences and is not expected to graduate prior to completion of the Summer 2026 internship. Have effective oral and written communication skills. Sufficient programming skills in SAS and/or R /or Python. Preferred Qualifications: Proficient in R and had experience of R Shiny in developing, testing and deploying dashboards about statistical metrics Be able to conduct literature review independently. Experience in the development and application of advanced statistical...

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. 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...

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...