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

Executive Director DMPK - (Hybrid 3 days per week in office) Top Tier Pharmaceutical company is expanding their high profile DMPK Team: Executive Director, DMPK Job Description: About the Role: Develops strategic plans, objectives and policies for overall function. Leads the Preclinical Pharmacokinetics function within the Preclinical Development organization. Provides scientific leadership and oversight to ensure that clinical candidates with acceptable drug development characteristics are identified and appropriately characterized and developed. Plays a key role in the discovery and advancement of

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 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

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

Title:               Associate Director, Global Monitoring Operations Reports to:      Sr. Director, Global Monitoring Operations Location:         Remote-based (US)   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

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 Scientific Director, Toxicology   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

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

Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)                  At 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

Associate Director-Quality Assurance (QA-CMC)   Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director, Quality Assurance to support drug development from Phase 1 to late-stage development. This position will provide CMC quality leadership within the organization and across our Contract Manufacturing Organizations (CMOs) and Contract research labs (CROs). This individual will partner with CMC, Clinical, Regulatory Affairs, and other