Senior Director, Regulatory Affairs - Northern NJ (Hybrid) Client is seeking a capable, insightful, experienced Senior Director, Regulatory Affairs Position Summary: The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department. The Senior Director will represent Company

Associate Director, Clinical Operations Job Description How you’ll make an impact: Contribute to the planning, implementation, and execution of global clinical trials. Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed. Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc. Provide study-specific

Senior Manager/Associate Director, Clinical Data Management (Hybrid; Greater Boston, MA)     How you’ll make an impact: Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies Interact and manage relationships with other functional areas to ensure high quality data management activities Oversight of data collection tools (EDC, DTAs, EDC integrations) and

Associate Director, Biostatistics Job Description:   Position Summary The Associate Director, Biostatistics is responsible for partnering with clinical, regulatory, data management and statistical programming teams to deliver robust statistical methodologies that advance clinical program objectives and ensure compliance with industry standards. This individual will contribute to the success of the team and organization by delivering on role- specific responsibilities while

Associate Director, Pharmacometrics, Clinical Pharmacology   Our client is seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a

Chief Medical Officer   POSITION SUMMARY The Chief Medical Officer is a strategic partner to the Chief Executive Officer, helps build, develop, lead and drive the Company’s preclinical through clinical pipeline. This leader is responsible for the company’s drug development portfolio including responsibility for prioritizing and accelerating the development of Company’s drug candidates. The CMO serves as

Position Summary (On-site) The Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are

About the Role: Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner. _ Your Contributions (include, but are not limited to): Responsible for the regulatory CMC leadership of one or

About the Role: The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Company’s Endocrinology pipeline, spanning early development through commercialization. This leader will oversee regulatory strategy for programs in rare endocrine disorders and obesity and will directly lead a team of three regulatory professionals. This role requires a

Position Summary (Hybrid; 2-3 days in office) The Clinical Trials Manager is responsible for the delivery of a key phase 3 clinical trial. This individual will contribute to the success of the team and organization by delivering high quality operational excellence on all delegated responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability

Associate Director or Director, Regulatory Affairs (Hybrid 3 days in office) How you’ll make an impact: The Associate Director or Director of Regulatory Affairs will be a key member of the STAT6 Regulatory team working in partnership with the Global Program Regulatory lead to develop and execute on innovative and creative global regulatory strategies. This will be a dynamic

Title: Senior Clinical Trial Manager (12 month contract) Reports to: Director, Clinical Operations         Reporting to the Senior Director, Clinical Operations, the Senior Clinical Trial Manager for Phase IV/Post-Marketing is responsible for leading Medical Affairs post-marketing studies. Candidate needs to hit the ground running, with all the key aspects of teamwork, collaboration and work ethic. This

Executive Director CMC/ Pharmaceutical Development Company is a publicly traded biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. All around the world, millions of people suffer from pernicious fungal diseases. At Company, we are bringing a ground-breaking class of drugs to the battle

Associate Director/Principal Medical Writer (3 openings); Remote   The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead

POSITION SUMMARY   Position Title: Vice President, Regulatory Affairs Reports to:   CMO   Company Summary: Client is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells.   We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies.   Client is

Job Description   The Director, Clinical Development – Inflammation will lead the design, execution, and oversight of clinical trials in support ofCompany’s inflammation portfolio. This individual will play a key role in shaping clinical strategy, collaborating cross-functionally with research, regulatory, safety, and commercial teams to advance innovative therapies that address unmet medical needs in inflammatory diseases. Job Responsibilities Lead

  Director, Medical Information & Operations       Reporting Structure Reports To: Chief Medical Officer & Vice President, Clinical Development Direct Report(s): Medical Affairs Operations Specialists, Medical Information and Medical Communications Areas Managed: Medical Information   Overview   This position will play an integral part in evolving and growing the needs of the Medical Affairs team and work

How you’ll make an impact: Contribute to the planning, implementation and execution of a global clinical trial Responsible for management of vendors to support clinical trial execution Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit

Sr. Manager, Bioinformatics Operations (Hybrid) - West   As the Regional Manager of the Bioinformatics Operations (Applications) team, you will lead the west region directly contributing to our focus of delivering actionable diagnostic insights that enable superior patient care. The focus of this role is to oversee and deliver high quality, stable and efficient Bioinformatics Applications in our genetic laboratories. You

Associate Director, Clinical Scientist   How you’ll make an impact: Serve as the study lead Clinical Scientist in immunology, actively participating in program team meetings, scientific advisory boards, and data/safety monitoring committees.   Support the design of clinical trial protocols, synopses, and amendments, ensuring scientific integrity and alignment with regulatory standards.   Conduct clinical and medical data reviews, including

Position can be Contract, Contract to Perm or Permanent (imminent need for a Contractor to be in place asap)!     Reporting to the Sr. Director, Clinical Excellence Operations the Senior Manager/ Associate Director, Records Management will   be responsible for expertise, oversight, implementation of systems and process improvement and training related to the trial master file (TMF

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

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

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

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

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

  Title:                  Sr. Director, Clinical Pharmacology Reports to:         SVP, Clinical Development Location:             US - Remote               

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

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

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

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

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

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

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

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

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

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

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

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

  Executive Assistant to the Founder Location: Hauppauge, NY (In-Office)   Position Overview Company is seeking a highly organized and proactive Executive Assistant (EA) to provide full-time, in-office support to the Founder. This is a pivotal role designed to streamline operations, enhance efficiency, and allow leadership to focus on high-impact strategic initiatives. The successful candidate will

Regulatory Affairs Manager Job Description   Overview •    Manage Company’s Regulatory Affairs for assigned products for US and Canada, including implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities. Essential Duties and Responsibilities •    Implement regulatory strategies supporting drug development and lifecycle management for US and Canada. •    Review