13 program management jobs found in Waltham

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. 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. An exciting opportunity to lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients. The Senior Director of Clinical Supply Chain ensures the uninterrupted, compliant, and cost-effective delivery of investigational products to global clinical trial sites. The ideal candidate will bring deep expertise in supply chain strategy, vendor oversight, and cross-functional collaboration, with a strong understanding of GMP, IRT systems, and regulatory requirements. Responsibilities Strategic Leadership Develop and execute global clinical supply chain strategies aligned with corporate and clinical development goals. Lead long-range planning and drive the continued development and transformation of supply chain infrastructure to meet the needs of the growing business. Partner with Legal, Finance, Trade Compliance, Quality Assurance, Regulatory Affairs,...

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. 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 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. 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. 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. 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. 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. 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. 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...