Back to List
Share:
SHARE
Details:
Job Type:
Direct Hire
Remote Status:
Compensation:
$1 - $2 / yr
Apply Later:
Send this job to your inbox!
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 be a leader in the organization who knows how to manage a team internally, at our clinical sites, and with our vendors.
- Lead and oversee the strategic planning, implementation and execution of clinical trials across a key immunology program in accordance with project timelines, budget, and quality standards
- Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
- Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones
- Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program
- Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards
- Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
- Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
- Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports
- In collaboration with the Head of Clinical Operations, hire, train and develop the Clinical Operations team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence
What skills and experience you’ll bring:
- BA/BS preferably in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field
- 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry
- Prior experience building and leading a team is a plus
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GCP
- Ability to manage multiple competing priorities and adapt to changes
- Strong communication, interpersonal, and problem solving skills
- Must be comfortable working in a fast-paced environment.
Apply to this Job
First Name *
Last Name *
Email
Phone
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 applicationSenior 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, DMPK
Featured
San Diego, CA
Direct HireHybrid 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
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 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 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
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
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 Scientific Director, Toxicology
Featured
San Diego, CA
Direct Hire
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
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
Clinical Trial Manager, Start Up
Featured
Boston, MA
Direct Hire
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)
Featured
Jersey City, NJ
Direct Hire
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
Loading Jobs...
