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- Pasadena, CA
new job!

The Clinical Trial Data Analyst is responsible for building programs to create datasets, listings, tables and figures from clinical databases, external data sources, and other sources. In addition, the position coordinates in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. Responsibilities: Prepare data reports, tables and graphs for regulatory submissions, IRB submissions,....

- Paramus, NJ
new job!

Software Engineer My client seeks a Software Engineer for a new role in their Bioinformatics group -- working to create scalable, high quality solutions to meet the demands of their rapidly growing biotech business. This work will be done in a team environment with constant communication among team members. The work environment requires multi-tasking and delivering quality work on multiple projects while meeting deadlines in a timely manner. The ideal candidate will take on the following....


My client is seeking a Supervisor to launch a new group and oversee a team conducting in-vivo oncology work. The ideal candidate will take on the following tasks:Provides the oversight and leadership of technical proceduresProvides training, technical guidance and mentoring of team membersSchedules work within the department and manages overtimeReview and approve study protocolsLiaise with cross-functional groups, different departments, and project Leadership to facilitate and maximize....


My established client seeks a Scientist for their Neurodegeneration group to take on the following tasks:Manage projects, develop work plans, and assist leadership team Perform stereotaxic surgeries and behavioral studies to support collaborationsManage data and perform statistical analysisPrepare and deliver presentations and reports, and contribute to manuscript preparationThe ideal candidate will possess the following qualities:PhD degree in Neuroscience or similarExperience with....


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....


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....


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....


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....

- 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....

- 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....


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....


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....


Clinical Research Physician Global Oncology Pharmaceutical company is expanding and looking to add an MD Strong base salary and benefits and long term incentives POSITION OBJECTIVE: The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job....

- 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....


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

Exciting science being performed at this Pharmaceutical company. Looking to hire two Clinical Operations Leaders under the direction of the New Vice President Clinical.he Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical

- Waltham, MA

Medical director - new products (depending on experience – may be senior or executive position) Reporting to VP & Head of Medical Affairs NA Staff responsibility Potentially yes Employment type Full time Purpose As a member of the NA medical affairs team this person will provide state of the art medical expertise and medical leadership for New Products Essential Responsibilities Lead the NA medical strategy and provide medical leadership and contribution for New ProductsProvide subject....


The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....

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