19 business development manager jobs found

Alkermes, Inc. Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases IIV of development. Responsibilities Clinical project team member: works closely with the Sr. CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation,...

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 Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a 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 Review clinical trial protocols and understand impact on supply Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans Create, review, and update...

MathWorks Summary MathWorks has a hybrid work model that enables staff members to split their time between office and home. The hybrid model provides the advantage of having both in-person time with colleagues and flexible at-home life optimizations. Learn More: https://www.mathworks.com/company/jobs/resources/applying-and-interviewing.html#onboarding. MATLAB & Simulink enable biomedical engineers worldwide to accelerate the pace of discovery in areas ranging from bioinstrumentation, biomechanics, medical imaging and optics, tissue and neural engineering, rehabilitation and surgical robotics and more. If you have experience with MATLAB & Simulink and are passionate about driving their adoption and usage in Biomedical Engineering, this is the role for you. As the Biomedical Engineering Market Development Manager, you will deploy your knowledge of MATLAB & Simulink and their applications in academia and industry, to support the company strategy and drive the...

Alkermes, Inc. The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases. You'll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization. Key Responsibilities: Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables. This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities. Serve as submission manager and primary contact for publishing vendors and internal stakeholders....

Merck Job Description Be a part of the legacy: Postdoctoral Research Fellow Program Our Research Laboratories' Postdoctoral Research Fellow Program aims to be a best-in-industry program for industrial postdoctoral researchers, designed to provide you with an academic focus in a commercial environment. With the resources, reach, and expertise of a large pharmaceutical company, postdoctoral researchers will be positioned to excel in an institution committed to breakthrough innovation in research and discovery. The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function at research laboratories is seeking a highly motivated postdoctoral fellow with expertise in machine learning to help transform drug discovery and preclinical development. You will join an interdisciplinary team and collaborate closely with research partners across our global organization. You will invent, prototype, and apply advanced Machine Learning (ML) methods-particularly in generative...

Merck Job Description Be a part of the legacy: Postdoctoral Research Fellow Program Our Research Laboratories' Postdoctoral Research Fellow Program aims to be a best-in-industry program for industrial postdoctoral researchers, designed to provide you with an academic focus in a commercial environment. With the resources, reach, and expertise of a large pharmaceutical company, postdoctoral researchers will be positioned to excel in an institution committed to breakthrough innovation in research and discovery. The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function at research laboratories is seeking a highly motivated postdoctoral fellow with expertise in machine learning to help transform drug discovery and preclinical development. You will join an interdisciplinary team and collaborate closely with research partners across our global organization. You will invent, prototype, and apply advanced Machine Learning (ML) methods-particularly in generative...

Merck Job Description Translational Biomarkers (TB) develops and validates clinical biomarkers to support decision making across the development lifecycle for all therapeutic areas at our Company's Research laboratories. We are seeking a highly-motivated Principal Scientist to serve as an Immunology Biomarker Lead who will partner across functions to design and deliver biomarker strategies that connect drug mechanism, patient biology, and clinical endpoints across immune-mediated and inflammatory diseases. The role requires a scientist who leads through scientific expertise, decision-focused logic, and collaboration, building alignment among teams on biomarker hypotheses, plans, and readouts tied to development decisions in a fast-moving matrixed environment. The individual will have the following responsibilities: Shape and align biomarker strategies for early and late-stage clinical programs, emphasizing clear hypotheses, fit-for-purpose readouts, and...

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. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for...

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. 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...

Capital One Current PhD, Applied Research Internship Program - Summer 2026 At Capital One, we are creating trustworthy and reliable AI systems, changing banking for good. For years, Capital One has been leading the industry in using machine learning to create real-time, intelligent, automated customer experiences. From informing customers about unusual charges to answering their questions in real time, our applications of AI & ML are bringing humanity and simplicity to banking. We are committed to building world-class applied science and engineering teams and continue delivering our industry leading capabilities with breakthrough product experiences and scalable, high-performance AI infrastructure. At Capital One, you will help bring the transformative power of emerging AI capabilities to reimagine how we serve our customers and businesses who have come to love the products and services we build. Participation in the program requires that you are located in the...

Alkermes, Inc. The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and is a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. The Principal Scientist works within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities Responsibilities: Serve as the primary Analytical Development representative on CMC teams, translate program objectives into phaseappropriate analytical strategies, plans, and timelines. Provide strategic CDMO oversight for analytical activities, which may include product...

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. 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. 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 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...