- Omeros Corporation (Seattle, WA)
- …ideas to positively impact clinical trials management Organizing and managing internal team meetings, investigator meetings and other trial-specific meetings; ... Omeros is seeking a Clinical Trial Manager/ Sr Clinical Trial Manager to join the Clinical...a member of our team, you'll work closely with internal team members and vendors as well as clinical… more
- Omeros Corporation (Seattle, WA)
- …happening at Omeros! Come join our Medical Affairs Team! Reporting to the CMO, the Senior Medical Director, Clinical Science will play a key role at all stages of ... the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans Will be part of a team… more
- Omeros Corporation (Seattle, WA)
- Omeros is seeking a Clinical Trial Specialist (CTS)/ Senior Clinical Trial Specialist ( Sr . CTS) to join the Clinical Operations Team. In this role you will be ... timely and accurate study-related communication to clinical personnel including internal and external study teams, consultants and investigative site personnel… more
- Omeros Corporation (Seattle, WA)
- …pharmacovigilance team, managing resources, workload quality and metrics and updating senior management of projects' progress Responsible for uniform processing of ... and standard operating procedures Interacts with and has oversight of internal and external global pharmacovigilance collaborators to ensure maintenance of… more
- Seattle Genetics, Inc. (Seattle, WA)
- Sr . Medical Director, Medical Affairs Employer Seattle Genetics, Inc. Location Bothell, WA, United States Posted Jun 11, 2019 Ref onNfafwj Discipline Clinical, ... need to sign in or create an account to save * Apply Summary: The Senior Medical Director will function as a scientific and medical expert for the Medical Affairs… more
- Seattle Genetics, Inc. (Seattle, WA)
- Seattle Genetics, Inc. Careers Sr . Medical Director, Medical Affairs Medical Affairs Bothell, Washington Apply Description The Senior Medical Director will ... and other staff. The role will interface with multiple internal functions including medical information, medical communication, medical affairs operations,… more
- Omeros Corporation (Seattle, WA)
- …to the Head of Regulatory Affairs of Omeros. The role works closely with senior leadership to ensure oversight of critical safety issues along with the management of ... Brochure (IDB), and/or Case Report Forms (CRFs) Attends and presents at Investigator Meetings Performs review and clarification of trial-related Adverse Events (AEs)… more
- Gilead (Seattle, WA)
- …serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), ... Investigator Sponsored Research (ISR) Studies, expanded access programs, and...-Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution… more
- Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
- …This position will be responsible for planning and conducting GCP audits (vendor, internal process and investigator site) and may include responsibilities for ... gathering and interpreting regulatory intelligence, as well as evaluating internal practices, making recommendations for improvement, and executing against action… more
- Amgen (Thousand Oaks, CA)
- …Worldwide Compliance & Business Ethics function focuses on the internal control framework including investigations, monitoring and risk assessment/mitigation. The ... Compliance Senior Manager is responsible for leading/conducting triage and investigation...and South America). This role is the lead LACAN investigator role. It can be based outside of Thousand… more
- Massachusetts Biotechnology Council (Seattle, WA)
- …Conducts medical monitoring of clinical development programs; writes protocols, investigator brochures, informed consent documents; responses to questions from ... and medical materials to ensure content is medically appropriate and compliant with internal and external requirements. * Keeps up to date on current relevant… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …a key contributing role in advancing an innovative oncology drug discovery pipeline. The Sr . Research Investigator will join the In Vivo Pharmacology Group at ... design, execute and analyze experiments and present their work at both internal and external meetings. The candidate is expected to leverage experience and… more
- Bristol-Myers Squibb Company (Cambridge, MA)
- Senior Research Investigator (IO Resistance Biology) Bristol-Myers Squibb R&D is a science-driven, passionate organization determined to discover, develop and ... biotech and academic communities. Roles and Responsibilities We are seeking a Senior Research Investigator , who will be responsible for evaluating mechanisms… more
- Eli Lilly and Company (Indianapolis, IN)
- …development of protocols, and data collection requirements. Participate in investigator identification and selection, in conjunction with the clinical pharmacology ... of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label… more
- Bristol-Myers Squibb Company (Redwood City, CA)
- Summary The Senior Research Investigator II will join the Immune Resistance Biology Research Team at Bristol-Myers Squibb in Redwood City, CA to support ... written communication, capable of presenting scientific results to multidisciplinary teams, senior management and at external scientific meetings. The candidate will… more
- Tocagen Inc. (San Diego, CA)
- …Agreement and applicable Statements of Work. Works closely with internal cross functional teams and external stakeholders: Implements pharmacovigilance standards ... of safety narratives, CSRs, and safety contents for filings. Assists in internal audits and regulatory inspections. Assists in undertaking activities to maintain a… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …Description : Developing bioanalytical strategies for various biologics programs following internal SOPs and Health Authority guidance. Acting as the bioanalytical ... liaison with clinical, and non-clinical internal cross-functional project teams and external collaborators Assisting in preparation of regulatory documents including… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …and training, applying ideas so obtained to work, presenting work at internal and external meetings. Requirements PhD in relevant scientific discipline (immunology, ... biology, biochemistry, etc.) with 4 or more years of relevant experience, or MS in relevant scientific discipline with 7 or more years of relevant experience. The candidate should have proven experience in leading developing de-novo immunochemistry based… more
- Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
- …including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: The Senior Clinical Study Lead (CSL) is accountable for the global execution ... clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study… more
- Amgen (Houston, TX)
- …speaker opportunities and concepts and letters of intent for investigator supported economics, humanistic outcome, and non-registration clinical studies to ... support Amgen's product messages within scope. 3. Interact with key internal stakeholders to provide feedback on customer trends in interpreting and using value… more
