Production Manager - 3rd Shift; Tuesday-Saturday 2am-10:30am   Manage the Specimen Management department areas (including Accessioning, Tech Ops, Referrals) to process specimens and on-time hand off to internal customers and with focus on quality, compliance, and productivity. The incumbent will own and ensure adequate workflow of specimens from sample of drop off through the time of transfer to the testing areas. The role is responsible for monitoring performance metrics across all areas, managing priorities, ensuring effective communications between

About the Role: As a Sr. Leader, executes the strategic direction of the Toxicology function. Ensures that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies and reviews reports. Advises and directs the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for discovery and development programs. Designs and develops overall Safety Pharmacology and Toxicology development strategies for toxicology

Position Overview: The Sr. Director, Regulatory Affairs US Advertising and Promotion will provide regulatory leadership to advance the development and planned commercialization of innovative therapeutic products. The successful candidate will report to the Sr. Director, Regulatory Affairs and lead regulatory guidance and review of externally facing communications for investigational and planned commercial products . Responsibilities: Provide regulatory leadership and expertise to the Medical Review Committee (MRC) and Medical, Legal and Regulatory (MRL) Promotional Review Committee with a focus on review and

Role Overview   The Vice President of Regulatory Strategy is responsible for providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre submission to approval. Responsible for addressing data requirements to regulatory authorities. This position will provide regulatory and technical expertise across the development of its product candidates. Prepares for and expedites early and effective approval of pharmaceutical new products in accordance with regulatory strategy. They will work cross-functionally with R&D, quality, clinical

Clinical Laboratory Scientist, Generalist Garden Grove, CA · Healthcare Job Title:  Clinical Laboratory Scientist, Generalist (Graveyard Shift) Location: Orange County, CA Position Type:  Full-Time, Graveyard Shift (11 PM - 7 AM) About Us:  Our client is seeking a director hire and is dedicated to providing accurate, timely, and high-quality diagnostic testing services to improve patient outcomes. As a leading reference laboratory, we are committed to excellence in healthcare and are looking for experienced professionals to join our team. Job Summary

Overview Specimen Processing Manager - Miramar, FL - Tuesday - Saturday 2:00am-10:30am Night Shift Oversee Specimen Processing, Imaging, and Tech Ops, may also oversee some or all of the following: Referral Testing and Test In Question. Responsible for overseeing the following activities: training of all personnel, all daily operations of related departments, Ensure all Compliance Policies are followed, low error rate, and productivity within company standards. Ensure maintenance of a safe, ergonomically sound, professional environment. Responsibilities ·        Must have the mental

  Title:                  Sr. Director, Clinical Pharmacology Reports to:         SVP, Clinical Development Location:             US - Remote                              Position Overview: As Company continues to advance the development of our broad portfolio, we are seeking a highly motivated scientist to be responsible for designing clinical studies and performing, interpreting, and reporting Pharmacokinetic/Pharmacodynamic (PK/PD) results. This individual will provide support in characterizing the clinical pharmacology profile of assets developed by Company as part of the overall pipeline. Specifically, the incumbent will support the pipeline by constructing, validating

How you’ll contribute: Lead development and execution of the Clinical Quality strategy while ensuring that it aligns with Company’s business strategy, GCP/GLP/GVP standards, and FDA/EMA/ICH requirements Develop, implement and monitor phase appropriate GCP/GLP/GVP Quality programs, policies and procedures to ensure compliance with applicable regulations Develop, implement and execute a risk-based audit strategy for clinical and non-clinical studies Lead and manage GLP/GCP/GVP audits program including oversight of consultant mediated and/or self-conducted Vendor, System, Study, and Process

Senior Director, Clinical Pharmacology Description   Reporting to the SVP of Research, the Senior Director, Clinical Pharmacology will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies, and will be accountable for delivering key translational milestones from candidate selection to BLA.    This role may be based in their Waltham, MA or Boulder, CO office. Their office-based employees are required to work in the office three (3) days a

Role Overview  Responsible for all regulatory affairs activities required to support lead, manage, review, and submit regulatory submissions to FDA including supplements, and post-approval reporting activities of marketed products. Lead and manage regulatory activities for labeling, promotional and advertisements. Lead and manage state licenses regulatory compliance.  Primary Duties & Responsibilities • Regulatory Affairs:  o Lead and manage all regulatory affairs-related activities for products o Serve as the regulatory liaison for FDA submissions and communicationso Lead, manage, review, and submit

Contract Remote Medical Director Title:                    Medical Director/Senior Medical Director, Clinical Development Reports to:          Head of Neuroscience Therapeutic Area, Clinical Development Position Overview: The Medical Director will support one or more development programs involving drug candidates in neuroscience.  This role will focus on crafting and executing clinical trials in clinical development and work as a medical monitor for one or more studies. The Medical Director will be responsible for designing and executing development strategies as well as interpreting data from clinical

Do you have a Toxicology background and strong Leadership? Our Publicly Traded Client is expanding. Looking for an Executive Director, Toxicology with strong Leadership experience. Company is based in San Diego and does require on-site presence. Robust compensation package offered including full relocation and other Long Term Incentives. Oversees and directs the activities of the Toxicology group. Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA

Senior Clinical Trial Manager Description Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company’s strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.     This role is based

Position Overview: The Associate Director (AD), Global Monitoring Operations is responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies at Company.  The AD, Global Monitoring Operations will also be responsible for management of assigned Company CRAs to optimize productivity and ensure quality, efficient end-to-end delivery of Monitoring Operations.  The AD, Global Monitoring Operations will support the development of process and practices within the Monitoring Operations function.   Responsibilities:   ·       In collaboration with Clinical Trial Management, initiate

ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project

Publicly Traded Biopharmaceutical company in Watertown, MA is expanding for their high profile clinical development trials. The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). The Director will

The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule (Must be in the Waltham 3 days per week).  Responsibilities Accountable for project related efforts for the delivery of studies or programs that

Senior Continuous Improvement Manager (3 openings; 3 locations)   Overview This is an Onsite position at Company's Tampa, FL, Miramar, FL and Tucker, GA facilities   The Company Management System (QMS) / Continuous Improvement (CI) Lead plays a key role in the definition, development, implementation, and on-going improvement of the QMS frameworks. The role will be responsible for the facilitation of QMS / CI events across the organization, helping form and inform new and existing Value Stream teams, and promoting accountability and

ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)   Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with

Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases.  We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best