Back to List
Share:
SHARE
Details:
Job Type:
Direct Hire
Remote Status:
Hybrid
Apply Later:
Send this job to your inbox!
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 safety monitoring activities, to ensure patient safety and data accuracy.
- Collaborate with Translational Medicine to embed bioanalytical sampling (e.g., PK/PD, biomarker assays) into trial protocols; ensure data flow to functional groups for analysis.
- Prepare and review essential documents such as medical monitoring plans, statistical analysis plans (SAPs), informed consent forms, and clinical study reports, supporting regulatory submissions.
- Work within a matrix environment, collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, statistics, and other departments to drive clinical development programs forward.
- Review monitoring reports, track protocol deviations, monitor data, query resolution, analyze trends, and prepare clinical study reports and regulatory submission materials.
- Present data and information to external investigators and internal stakeholders, contributing to meetings with governance bodies and regulatory authorities.
Skills and experience you’ll bring:
- Bachelor’s or advanced degree (MSc, PharmD, MD, PhD) in Life Sciences, Pharmacology, or related field.
- 4+ years in pharmaceutical clinical drug development, with experience in global clinical trials and program execution.
- Proficiency in immunological diseases (e.g. Atopic dermatitis, Asthma) including an understanding of disease biology and treatment landscapes.
- In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP).
- Strong problem-solving abilities and excellent medical writing skills.
Apply to this Job
First Name *
Last Name *
Email Address *
Phone Number
Yes
No
Toggle Filters
Job Type
Remote Status
Create a Job Alert
Get notified about new listings!
Submit a Resume
Can't find the job you want?
Submit a general applicationProject Manager, Medical Affairs
Featured
Bridgewater, NJ
Contract
Contract Medical Affairs Project Manager (Hybrid; 1 year contract)
Overview
The Medical Affairs (MA) Project Manager will oversee the operational execution of the Osilodrostat Evidence Generation Plan, ensuring timely delivery of studies, publications, and guideline updates that support brand growth and Company’s vision. This role will manage cross-functional and external partner coordination, ensuring scientific, compliance, and budgetary excellence across a portfolio of high-impact initiatives.
Essential Duties and Responsibilities
Lead project management of the Osilodrostat Evidence Generation Plan
Associate Director, Clinical Scientist
Featured
Watertown, MA
Direct HireHybrid
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 safety monitoring activities, to ensure patient safety and data accuracy.
Collaborate with Translational Medicine to embed bioanalytical sampling (e.g., PK/PD, biomarker assays) into
AD/Dir Regulatory Affairs (Strategy)
Featured
Florham Park, NJ
Direct Hire
Job Description – AD/Dir Regulatory Affairs
Reports To: SR Director- Regulatory Affairs.
· Prepare and review various modules of ANDAs, and responses to FDA queries.
· Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for ANDA’s.
· Hands-on work experience on eCTD modules 1, 2, 3 and 5 is required.
· Proven ability to manage competing priorities and multiple filings in a dynamic environment is required.
· In-depth knowledge and experience of regulatory CMC documents review, and approval
Production Manager
Featured
Miramar, FL
Direct Hire
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
Senior Scientific Director, Toxicology
Featured
San Diego, CA
Direct HireHybrid
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
Vice President Regulatory Affairs Strategy
Featured
Florham Park, NJ
Direct HireHybrid
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 Laboratoy Scientist (2 Openings)
Featured
Garden Grove, CA
Direct HireOn-Site
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
Specimen Processing Manager
Featured
Miramar, FL
Direct HireOn-Site
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
Senior Director, Clinical Pharmacology
Featured
South San Francisco, CA
Direct HireFull Remote
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
Senior Director, Clinical Pharmacology
Featured
Boston, MA
Direct HireHybrid
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 Director, Regulatory Affairs - Advertising & Promotion
Featured
Morristown, NJ
Direct HireHybrid
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
Medical Director, Clinical Development
Featured
South San Francisco, CA
ContractFull Remote 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, Toxicology
Featured
San Diego, CA
Direct Hire 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
Featured
Waltham, MA
Direct HireHybrid
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
Associate Director, Global Monitoring Operations
Featured
South San Francisco, CA
Direct HireFull Remote
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
Featured
Waltham, MA
Direct Hire
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
Director, Clinical Operations
Featured
Watertown, MA
Direct Hire
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
Clinical Trial Manager
Featured
Waltham, MA
Direct HireRemote Available 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
Featured
Tampa, FL
Direct Hire
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
Featured
Waltham, MA
Direct Hire
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
Loading Jobs...
