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Associate Director, Biologics Development Position Overview The Associate Director, Up-stream , will be an instrumental team member of the Biologics Development Process Sciences Department, based in Irvine, CA. The primary roles of this position are to independently plan, design, and execute the experiments and develop processes to support protein expression, fermentation, and purification process development of natural and recombinant proteins (including neurotoxin and antibodies) from....

- New York City, NY

BIOSAMPLE OPERATIONS SPECIALIST Drives alignment of study and project level strategies within the overarching therapeutic area strategy for biosamples, through close partnership with the Biosample Therapeutic Area Leaders (BTALs), service providers (including lab vendors) and DTA stakeholdersIs responsible for the delivery and implementation of the biosample strategy within multiple clinical programmes in accordance with the requirements of quality, ethical and regulatory standards including....


Sr. Manager / Director, Medical Affairs Overview: Diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what....

- Wayland, MA

Essential Job FunctionsServe as the lead Clinical / Medical Report Writer contributing to a variety of documents for clinical research and regulatory purposes, including clinical research protocols, annual and final study reports, investigator’s brochures, and regulatory submissions including clinical summary reports (CSR), clinical evaluation (CER), and post-market surveillance (PMS) reports.Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate....


Pharmaceutical company is hiring an Associate Director Medical Writing for their Waltham Massachusetts location.We are a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, we apply our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our....


Medical Affairs – Fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. In this highly visible leadership role in Medical Affairs, you will work closely with a cross-functional group that includes....


Position Overview Provide analytical expertise and leadership in the development of drug substances and pharmaceutical products from early development through commercialization. Plan analytical research and development activities, devise strategies for achieving project goals and independently manage CMC timelines. Make pivotal contributions to drug product development strategy at project team level. Independently manage multiple projects and ensure timely delivery of all deliverables to meet....


Associate Director, Process Development Position Summary: This position will support the development of novel active compounds within the company pipeline. Specifically, this position will provide strategic leadership for drug substance unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Specific areas of focus include reaction engineering, crystallization and process modeling. The individual is expected to integrate QbD....


Assoc Dir, Clinical Trial Management Position Overview The Associate Director is responsible to lead and drive clinical operations for their assigned global clinical studies/programs and to ensure the global clinical studies/programs are executed to support the successful registration of new products/indications. They will manage resources, training and budgets for their GCTM teams. They will provide input to the operational strategy and into key documents for example study protocols and....


The job holder is accountable for driving improvement focused initiatives across Clinical Operations and for the development and implementation of effective processes and best practices for SP&CO and group functions. S/he aligns with the evolving business strategy throughout the organization and develops and maintains the strategic framework for efficient information management as well as the portfolio of projects/initiatives driving improved efficiency. The postholder is accountable for....


Global Specialty Pharmaceutical company in Bridgewater, New Jersey is looking to hire a Manager of Clinical Quality AssuranceThe Manager Clinical Quality Assurance is a key member of the company Research and Development organization. This role is responsible for Clinical QA activity related to the planning, conduct, and reporting of GCP audits in order to ensure that clinical studies are conducted in compliance with applicable regulations, guidelines and company standards. This role also has....


Leading Global Pharmaceutical company with office in Waltham Massachusetts Manager, Health Economics & Outcomes Research (HEOR) Position Summary: The Manager for Health Economics & Outcomes Research (HEOR), will be responsible for supporting HEOR activities for company's products. This individual will contribute to evidence generation, development of strategy, data analysis and dissemination and support the HEOR Senior team members (Directors, Senior Directors).....


GLOBAL PHARMACEUTICAL COMPANY IS HIRING A HEAD OF MEDICAL AFFAIRS FOR RENAL Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical Team. The position can be either a Senior Director or Executive Director based upon the individual's experience. The Medical Lead is knowledgeable of the actions of regulatory bodies, in particular, knowledge of the FDA. He/She has....


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....


The Director/Sr. Director of Clinical Development Operations is responsible for clinical operations planning, oversight and execution of multiple studies within one or more clinical development programs. Strategic development and coordination of operational approaches, guiding study level staff, and optimizing vendor performance. Sophisticated internal (cross functional team members) and external (KOLs, site staff) stakeholder communication and interface. Manage and/or mentor Clinical Trial....

- Buffalo, NY

Clinical Project Manager As a Clinical Project Manager (CPM), you will work in a matrix management environment and serve as the primary contact for interdepartmental and external study contacts. This experienced CPM role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The CPM may also function as the liaison and provide support for sponsor managed studies in an international setting, and, may oversee....

- Bridgewater, NJ

The CTM will work closely with the Director, Clinical Operations and Clinical Development team on the design, execution and oversight of clinical trials (all clinical phases) related to pharmaceutical product development and registration. The CTM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, IIT studies, compassionate use and registries) including data management activities, ensuring that clinical studies are....


Preferred Qualifications: · Clinical experience in or outside the US · Infectious Disease training with clinical and/or research background. · Knowledge of vaccine trial design and marketing issues. · The ideal candidate would be someone recognized by other vaccine experts as being expert in vaccinology or a related discipline. An acceptable candidate will have achieved recognition as highly experienced in relevant matters, e.g. infectious diseases, public health, clinical trials, etc. · The....


Represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of global regulatory strategy on R&D project teams. Leads team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, EU JP) with responsibility for working with colleagues on a worldwide basis....

- Cambridge, MA

Global Company is hiring a Senior Leader Clinical Operations Biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Company is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications This position will be responsible for initiating and leading....

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