Current jobs related to Clinical Operations Director - Cambridge, Massachusetts - QurAlis
-
Senior Director of Clinical Operations
2 weeks ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob DescriptionJob Title: Senior Director, Clinical OperationsCompany: Akebia TherapeuticsJob SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Clinical Operations to lead our clinical development programs. The successful candidate will have a strong background in clinical trial management, with a proven track record of delivering...
-
Director of Clinical Operations
3 weeks ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeJob SummaryWe are seeking a highly experienced Director of Clinical Operations to lead our Oncology programs. The successful candidate will be responsible for managing clinical programs, overseeing CROs and vendors, and working cross-functionally on clinical operations strategy and related initiatives.Key ResponsibilitiesDevelop and execute clinical...
-
Clinical Operations Director
2 weeks ago
Cambridge, Massachusetts, United States QurAlis Full timeAbout QurAlisWe are a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.Job SummaryWe are seeking a motivated experienced Vice President of Clinical Operations...
-
Cambridge, Massachusetts, United States Moderna Full timeThe Role: Moderna is seeking a seasoned Associate Director to lead the Biomarker Operations group within the Clinical Biomarkers Department. This position will provide strategic leadership to impact biomarker operations deliverables in collaboration with biomarker leads, clinical teams, and partner CROs.Key Responsibilities:Supervise and lead a team of...
-
Clinical Trials Director
2 weeks ago
Cambridge, Massachusetts, United States Garuda Therapeutics, Inc. Full timeJob DescriptionWe are seeking a highly skilled Clinical Trials Director to lead the planning, implementation, and execution of global clinical trials. As a key member of our team, you will be responsible for managing clinical trials from start-up through close-out, ensuring that all components of the trial deliverables are executed to specified quality...
-
Cambridge, Massachusetts, United States Moderna Full timeThe Role:Moderna is seeking a seasoned leader to provide strategic direction and oversight to the Biomarker Operations group within the Clinical Biomarkers Department. As Associate Director, you will collaborate with biomarker leads, clinical teams, and partner CROs to drive biomarker operations deliverables and ensure compliance with regulatory...
-
Clinical Data Management Director
3 weeks ago
Cambridge, Massachusetts, United States Third Harmonic Bio Full time{"title": "Clinical Data Management Director", "description": "About Third Harmonic BioThird Harmonic Bio is a biopharmaceutical company dedicated to developing innovative treatments for severe allergy and inflammation. Our mission is to create a breakthrough treatment for people living with debilitating conditions that impact overall health and...
-
Assistant Nurse Director
2 weeks ago
Cambridge, Massachusetts, United States Mass General Brigham Full timeJob Description & RequirementsSpecialty: OR - Operating RoomDiscipline: RNDuration: Ongoing40 hours per weekShift: 8 hours, daysEmployment Type: StaffAt Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. When determining base pay, we take a comprehensive approach that considers your...
-
Associate Director Data Operations
3 weeks ago
Cambridge, Massachusetts, United States Randstad Full timeJob Title: Associate Director Data OperationsWe are seeking a highly skilled Associate Director Data Operations to join our team at Randstad. This is a contract position based in Cambridge, Massachusetts, with a salary range of $56.47 - $74.99 per hour.Job Summary:The Associate Director Data Operations will be responsible for supporting Digital Health...
-
Clinical Trial Oversight Director
3 weeks ago
Cambridge, Massachusetts, United States Alnylam Full timeJob Summary:The Associate Director, Clinical Trial Oversight will provide leadership and clinical operations experience to support Alnylam's oversight of CRO monitoring effectiveness. This position reports to the Director, Clinical Operations.Key Responsibilities: Develop and implement Alnylam's Clinical Trial Oversight strategy in alignment with ICH GCP E6...
-
Associate Director Data Operations
3 weeks ago
Cambridge, Massachusetts, United States System One Full timeJob Title: Associate Director Data OperationsWe are seeking an experienced Associate Director Data Operations to join our team at System One. As a key member of our organization, you will be responsible for overseeing the operational and vendor engagement aspects of our Digital Health Technology (DHT) and imaging components set-up and monitoring within...
-
Associate Director, Biomarker Operations
3 weeks ago
Cambridge, Massachusetts, United States Moderna Full timeAbout the RoleModerna is seeking an experienced Associate Director to lead the Biomarker Operations team within the Clinical Biomarkers Department. As a key member of our team, you will provide strategic leadership and direction to drive the innovation and compliance of biomarker biosample management plans for all clinical trials conducted by Moderna.Key...
-
Associate Director Clinical Science
1 month ago
Cambridge, Massachusetts, United States FogPharma Full timeUnlock the Future of Precision MedicineFogPharma is a pioneering biopharmaceutical company revolutionizing the discovery and development of Helicon therapeutics, peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions.Join Our MissionWe are seeking an exceptional Associate Director/Director, Clinical...
-
Clinical Operations Supervisor
3 weeks ago
Cambridge, Massachusetts, United States ProPivotal Full timeRN (Registered Nurse) CoordinatorThis role involves supervising the clinical operations of all nursing floors in the absence of the Nurse Manager and/or Director of Nursing, and assuming administrative responsibilities for the Center in the absence of executive administrative personnel.Key Responsibilities:Make clinical rounds to ensure appropriate nursing...
-
Clinical Director
3 weeks ago
Cambridge, Massachusetts, United States Strong Force Staffing Full timeAbout the JobClinical Director - Home HealthLocation: Cambridge, MassachusettsCompany: Strong Force Staffing (RPO for Client Agency)OverviewStrong Force Staffing is a leading recruitment process outsourcing firm dedicated to building stronger teams for a stronger tomorrow. We connect skilled professionals with dynamic employers, ensuring mutual growth and...
-
Clinical Development Director
1 month ago
Cambridge, Massachusetts, United States Sarepta Therapeutics, Inc. Full timeJob SummaryThe Director, Clinical Development is a key leadership position responsible for driving the advancement of Sarepta's clinical-stage programs. This individual will lead a clinical sciences team and be accountable for defining strategic priorities and integrating cross-functional input to develop and execute the clinical development plan.Key...
-
Clinical Sciences Associate Director
4 weeks ago
Cambridge, Massachusetts, United States Novartis Group Companies Full timeAbout the RoleWe are seeking a highly experienced and skilled Clinical Sciences Associate Director to join our team at Novartis Group Companies. This is a key leadership position that will be responsible for leading cross-functional teams in the design, execution, and delivery of complex global early-phase oncology trials.Key ResponsibilitiesLead global...
-
Clinical Director
2 weeks ago
Cambridge, Massachusetts, United States Strong Force Staffing Full timeAbout the Clinical Director - Home Health OpportunityWelcome to Strong Force Staffing, where we connect skilled professionals with dynamic employers. As a Clinical Director - Home Health, you will oversee clinical operations, ensuring the delivery of high-quality home health services. Your leadership will be instrumental in shaping the future of patient...
-
Medical Director
3 weeks ago
Cambridge, Massachusetts, United States Planet Pharma Full timeJob SummaryPlanet Pharma is seeking a highly skilled Medical Director to provide clinical input to SAD/MAD studies. The ideal candidate will have industry and allergy experience, with a strong background in clinical settings.Key ResponsibilitiesProvide clinical input to SAD/MAD studiesHelp design and implement early POC studiesMedical monitoring of early POC...
-
Director of Quality Operations
3 weeks ago
Cambridge, Massachusetts, United States Meet Full timeJob Title: Director of Quality OperationsSummary:The Director of Quality Operations is responsible for overseeing commercial product distribution and maintaining Good Distribution Practices (GDP) for the US affiliate. This role manages third-party logistics providers, handles product release for distribution, and ensures compliance with GDP regulations and...
Clinical Operations Director
2 months ago
We are a clinical-stage biotechnology company pioneering precision medicines for neurodegenerative diseases. Our team of neurodegenerative biologists from Harvard Medical School and Harvard University is dedicated to advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
Job SummaryWe are seeking an experienced Vice President of Clinical Operations to oversee the transition of our discovery projects into clinical trials. The successful candidate will be responsible for timeline management, risk assessment, risk mitigation planning, and cross-functional communication in a largely externalized environment.
Key Responsibilities- Spearhead and Champion Clinical Operations
- Oversee and manage all operations and staff involved in clinical operations, data management, and other groups as assigned.
- Ensure that clinical trials are properly resourced, managed, executed, and inspection-ready in accordance with timelines, good quality practices, and applicable regulatory requirements.
- Apply expertise to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.
- Participate in the review, planning, and implementation of clinical trials, evaluating hypotheses, objectives, study design, feasibility, and regulatory requirements.
- Develop clinical timelines, budget forecasts, and ensure accountability for tracking and deliverables.
- Oversee CROs and vendors from identification and selection to close of contracts.
- Collaborate with others on the development of protocols, annual safety reports, clinical study reports, publications, presentations, and regulatory submissions.
- Review relevant master service agreements, statements of work, and quality agreements.
- Regularly present clinical operations updates and strategy to QurAlis' executive committee.
- Evolve the Clinical Operations Department Infrastructure
- Lead initiatives to build the clinical operations department infrastructure.
- Plan clinical operations headcount and hiring needs to meet program workload demands.
- Represent and advocate for clinical operations needs and resources at the Executive Committee level.
- Mentor Your Team and Develop Their Talents
- Lead the members of the clinical operations team by example.
- Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs.
- Provide leadership, mentorship, and development opportunities to others within QurAlis.
- Minimum of 15 years of clinical operations experience in the pharmaceutical/biotech industry, with at least 8 years of direct line management experience.
- BS/MS in a scientific discipline or equivalent experience.
- Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations, and regulatory components is essential.
- Proven success in leading and coordinating cross-functional clinical operations teams.
- Experience working on complex studies involving biomarkers and activities across multiple vendors.
- Knowledge and experience with developing, negotiating, and managing contracts (vendor and site).
- Experience in regulatory inspection.
- Experience in developing RFPs, selection of CROs/vendors, and management of external resources.
- Demonstrated ability to manage international clinical trials within designated program budgets and timelines.
- Proven success participating in cross-departmental clinical strategy, planning, and implementation activities.
- Strong working knowledge of FDA, EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices.
- Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness, and ability to work in a fast-paced team environment.
- Experience with building clinical operations infrastructure, including writing of SOPs.
- Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing.
