29 jobs found

Biogen Job DescriptionAbout This RoleBiogen seeks a highly motivated individual to join the Immunology Research Unit. We are seeking an individual with experience using in vitro and ex vivo experimental approaches, whose goal would be to advance drug discovery programs. This individual will join a stellar team of scientists focused on the designing and execution of experiments aimed at target discovery and understanding the mechanism of action of drug candidates being developed to treat autoimmune diseases. The individual is expected to work independently in a fast-paced, collaborative environment, build strong interactions with team members and be an active participant on multidisciplinary project teams.What You'll Do Design and execute experiments critical for target validation and in vitro and in vivo pharmacologyDrive drug discovery efforts for ImmunologyUse a wide array of techniques relevant to neuroimmunology and immunology (Flowcytometry, FACS, IHC, Spatial...

Alkermes, Inc. On Nov. 2, 2022, Alkermes plc announced its intention to explore separation of its oncology assets, including nemvaleukin alfa, IL-12 and IL-18. Alkermes plc intends to create a new, publicly-traded company to develop and commercialize such oncology assets. Referred to herein as "Mural Oncology." Alkermes, Inc., a subsidiary of Alkermes plc, is recruiting the position of Analytical Development for Mural Oncology in advance of its establishment as a publicly-traded company on The Nasdaq Stock Market. GENERAL DESCRIPTION: The Associate Principal Scientist position within the Analytical Development will lead biologics analytical activities in a matrix environment. The successful candidate will work with a cross-site analytical development team to characterize biotherapeutic candidate molecules from discovery through clinical development, to commercialization. The role also provides laboratory support via reference standard management, overseeing analytical...

Alkermes, Inc. The Senior Vice President, Clinical Development will be responsible for working closely with colleagues across the Alkermes Research and Development organization to shape and execute clinical development plans to efficiently advance molecules through the development pipeline. Reporting to the Chief Medical Officer /Head of Research & Development, will be responsible for overseeing the successful development of programs with a focus on CNS. Will collaborate with clinical development colleagues to oversee the design and timely progression of associated clinical trials. The successful candidate will have responsibility for the development of compounds across Neurology, Neuropsychiatry and Neuroimmunology.The ideal candidate will provide strategic leadership and hands-on management of Alkermes Clinical Development functions. This individual will be a highly innovative, collaborative, scientifically grounded and accomplished Clinical Development physician with a...

Alkermes, Inc. The Quality Systems Lead will manage Quality System applications, including Veeva, and will be ultimately responsible for ensuring that the quality system is compliant, and its operations are fit for intended use in accordance with applicable global procedures. This role will report into the Manager, Validation Quality Systems.PDN-99416350-12b5-48e7-b5f0-c962a224d393

Position Summary: Responsible for ensuring that clients receive the individual range of medical care and other comprehensive services necessary to optimize each client's substance use, mental health, and health outcomes. Essential Job Functions include those listed below. ESSENTIAL JOB FUNCTIONS: It is responsible for the social evaluations of all Project participants. Responsible for participating in the initial interview for the determination of needs and maintaining the social reports of each of the participants, carrying out assessments of an emotional nature, self-esteem, independent living capacities, for the different departments needed. Takes care of making the participant's social history. Assess participants' needs in conjunction with the team and other peers In charge of all that is support groups and carrying out service activities daily. Gives individual and group therapies aimed at mastering social and community skills. It is...

Position Summary: Responsible for ensuring that clients receive the individual range of medical care and other comprehensive services necessary to optimize each client's substance use, mental health, and health outcomes. Essential Job Functions: It is responsible for the targeted evaluations of their substance abuse of all Project clients. It is responsible for participating in the initial interview for the determination of needs and maintaining the social reports of each of the clients, carrying out evaluations of an emotional nature, self-esteem, independent living abilities, for the different necessary departments, making psychoactive history of the client She gives individual and group therapies aimed at substance abuse and improves social and community skills. Realization of treatment plans and collection of services performed on clients Design plans that guide the client in achieving their goals. It contributes to the development and increase...

Alkermes, Inc. The following position is for Alkermes, Inc. On Nov. 2, 2022, Alkermes plc announced its intention to explore separation of its oncology assets, including nemvaleukin alfa, IL-12 and IL-18. Alkermes plc intends to create a new, publicly-traded company to develop and commercialize such oncology assets. Referred to herein as "OncologyCo." Alkermes, Inc., a subsidiary of Alkermes plc, is recruiting the position of Associate Director/Director, Reporting and Compliance for OncologyCo. in advance of its establishment as a publicly-traded company on The Nasdaq Stock Market. Description: We are looking for a dynamic Head of Regulatory Affairs whose responsibilities include regulatory oversight and strategic development of our products throughout the product lifecycle. This individual will lead Regulatory Strategy, Regulatory Operations, Regulatory CMC, and Medical Writing. Success in this role requires strong leadership skills, exceptional working knowledge of global...

Biogen Job DescriptionAbout This Role The Biomarkers group discovers and applies innovative & impactful imaging biomarkers. We assess their application to CNS drug development; and their utilization in the understanding of normo- and patho- physiology in disease models and in humans. We develop new, non-invasive imaging tools to aid in the drug discovery and development process, e.g. identify the right patients, pharmacodynamic measures associated with disease process and pharmacological intervention, and aid in dose selection is a critical area of development for Biogen.We are seeking a highly motivated, results-oriented imaging scientist to join our group and lead in vivo MRI activities.What You'll Do Responsible for the operation and development of advanced imaging techniques on both 7 and 9.4T MRI systems.MRI sequence design, acquisition, processing, and image analysis and have a good understanding of disease biology and be comfortable working collaboratively in...

Alkermes, Inc. Recently, Alkermes announced its intention to explore a separation of its oncology business into an independent, publicly-traded company with assets ranging from pre-clinal to pivotal stage development. The new hire for this position will join Alkermes, but in the event the separation of the oncology business occurs (which, if completed, would likely occur in the second half of 2023), the expectation would be that the employee would become part of the Clinical Operations department within the newly-formed oncology company supporting the development of biological drug products. As Director/Senior Director, Therapeutic Area Clinical Operations Lead, Oncology you will be responsible for the effective leadership, strategic planning, and oversight of Alkermes Oncology assets in Clinical Trial Management ensuring the operational execution of a portfolio of clinical development studies through: Global Operational Strategy and Planning Clinical Study Execution and...

Alkermes, Inc. Alkermes, Inc is seeking a Senior Director/Executive Director to join the Health Economics & Outcomes Research (HEOR) team located in Waltham, MA. The Sr/Exec Director will lead Alkermes' HEOR team for the neuroscience franchise. Ultimately, the Sr/Exec Director is a high-profile position that will drive HEOR's leadership in the development of value strategies and generation of market-relevant evidence to differentiate Alkermes' brands and enhance our clinical stage pipeline. The ideal candidate for this role is a highly motivated self-starter who is able to work independently, deal with complex issues, develop creative solutions to complex problems, and relate to multiple internal and external stakeholders. The incumbent will lead a team to develop and execute strategic plans to support the value proposition of Alkermes' commercialized and pipeline products in neuroscience. The Sr/Exec Director will collaborate with colleagues in other functional areas in the...

Biogen Job DescriptionAbout This Role As clinical demand signals grow more complex, the need for comprehensive and dynamic clinical supply chain services continues to intensify. The Associate Director, Clinical Supply Capabilities (IRT), will provide broad-based leadership supporting the supply of material to clinical studies. Clinical Drug Supply reports in the Global Supply Chain organization and is full accountable for end to end clinical supplies. We are seeking an experienced candidate to support operations, functions of critical business systems and processes within Biogen's Clinical Drug Supply (CDS) organization. The role requires a deep understanding of supply chain networks, clinical regulations, timelines and analytics to facilitate communications across a variety of functions, and to develop cost effective clinical supply solutions balancing multiple business objectives.The Associate Director, Clinical Supply Capabilities plays a critical role in Biogen's Clinical Drug...

Alkermes, Inc. Sr. Director, Regulatory Operations This position will report to the Head of Regulatory Affairs and will be responsible for oversight of the Regulatory Operations function, including publishing and submission of INDs, NDAs, briefing packages, clinical protocols/amendments, clinical study reports, post approval supplements, and 2253 submissions. The position will work closely across Regulatory Affairs and Medical Writing to ensure seamless end-to-end preparation and submission of dossiers to FDA. The individual will have responsibility for: Overseeing the Regulatory Operations function and vendors to ensure regulatory submissions are compiled accurately, in their entirety, and within specified timelines while maintaining quality Coordinating with external vendors on timely issue identification, resolution, and implementation of solutions, as well as timing of submissions to FDA through the electronic gateway Working closely with Regulatory Affairs and...

Alkermes, Inc. JOB DESCRIPTION: The Senior Director position is responsible for leadership of the Analytical Development department at our Waltham site with accountability for analytical activities from Discovery (lead generation, lead optimization and nomination) through early-stage clinical development for small molecule programs. The candidate will ensure success on all drug substance and drug product Analytical Development deliverables to CMC teams through both internal and external resources. They will also be responsible for strategic and scientific alignment of the Analytical Development activities and team members with the overall program needs. The candidate should have a proven track record of leadership, mentorship, and focus on career growth of their teams in a cross-functional environment. They should be a strong role model for the scientific community in the company by effectively managing technical details with their team and providing expert opinions. This...

Alkermes, Inc. Provides quality control (QC) and formatting to ensure submission readiness of clinical documents and coordinates clinical study report (CSR) appendices. Serves as a technical resource for questions regarding Alkermes procedures for QC, submission readiness, and CSR appendices. Acts as the medical writing expert for formatting documents according to Alkermes editorial style for regulatory documents. This position can be remote.PDN-99131eb3-b376-499d-9e5f-4587ae34cfa7

Acushnet Company WE ARE A PRODUCT COMPANY.WE ARE A PROCESS COMPANY.ABOVE ALL, WE ARE A PEOPLE COMPANY.The history of the Acushnet Company is tightly woven into the fabric of golf. From the start, we've been committed to enriching the experience of dedicated golfers through superior product performance, technological innovation, unmatched quality, and exceptional service. We are more than a collection of leading golf brands and products. We are a team united in our passion for the game. We are bridge builders who embrace our responsibility to leave our brands, businesses, communities, and the game of golf in a better position than when we started.Together we live by the credo, "Autograph your work with excellence." We earn our position as unrivaled leaders in every category in which we compete, striving for excellence in all that we do - from the performance and consistency of our products to our engagement with golfers and trade partners, to our commitment to creating a workplace...

Alkermes, Inc. In this leadership position, the Senior Director/Executive Director, Biostatistics will direct a team of statisticians supporting drug development activities and decision-making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements. PDN-98fabbf9-6472-4186-a216-af019bdf32a2

Alkermes, Inc. Overview The Senior/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...

Alkermes, Inc. Recently, Alkermes announced its intention to explore a separation of its oncology business into an independent, publicly-traded company with assets ranging from pre-clinal to pivotal stage development. The new hire for this position will join Alkermes, but in the event the separation of the oncology business occurs (which, if completed, would likely occur in the second half of 2023), the expectation would be that the employee would become part of the Formulation Development department within the newly-formed oncology company supporting the development of biological drug products. Position Description: We are seeking a highly skilled formulation and drug product development scientist to join our team. The Senior Scientist role will lead formulation and drug product manufacturing activities on a new oncology program. Prior experience supporting and selecting GLP-tox formulations and overseeing the manufacture of drug product are desired. The candidate will work...

Alkermes, Inc. Director/Senior Director Translational Medicine - Neuroscience Alkermes is seeking an accomplished expert in neuroscience translational medicine and early-stage clinical drug development strategy and tactics. In the role of Senior Director or Director, Translational Medicine, you will be accountable for developing and executing clinical translational medicine strategies as a core member of preclinical and clinical-stage project teams in neurology and psychiatry. Top applicants have authoritative knowledge of the full array of biomarker contexts of use for drug discovery and development and the state-of-the art of neuroscience clinical biomarker research. The primary responsibilities for this individual include, but are not limited to, creating strategies and detailed plans to demonstrate target engagement, proof-of-mechanism and pharmacodynamic response to treatment, characterize biomarker-driven PK/PD relationships, and explore early signs of efficacy and...

Alkermes, Inc. Alkermes Overview:Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.The following position is for Alkermes, Inc. General Description: The Senior Scientist/Associate Principal Scientist position within the...