Senior Director, Head of Clinical Program Quality & Excellence (TAU) 3316 Takeda Development Center AmericasSenior Director, Head of Clinical Program Quality & Excellence (TAU)MassachusettsYou will provide quality leadership to key governance bodies, identify and mitigate emerging risks, and lead the Clinical Program Quality & Excellence team to embed operational excellence, patient safety, data integrity, and global regulatory compliance across clinical trial delivery. As the Senior Director, Head of Clinical Program Quality & Excellence (TAU), you will drive a risk-based quality management approach across the Therapeutic Area Unit, strengthening clinical program performance, regulatory confidence, and inspection readiness.
Senior Director, Clinical Development Definium Therapeutics IncSenior Director, Clinical DevelopmentBoston, MA$247,649–$298,800 / yearResponsibilities: • Provides clinical science leadership within assigned teams or programs • Manages the design, planning and execution of clinical trial program(s) as needed with minimal guidance • Is able to play a leadership role in subject matter expertise when interacting with global health authorities • Has deep familiarity with registration submission strategies and can manage the Clinical needs for all submissions as needed • Leads the study design, implementation and execution of clinical trials on assigned programs • Is responsible for the preparation of clinical study synopses and serves as a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports • Works cooperatively with project team members to provide clinical development expertise and leadership • Responsible for identifying and cultivating relationships with relevant national and international thought leaders to further project goals • In partnership with Regulatory Affairs and Project Management, oversees and ensures the quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS, ISEs and clinical expert reports, including writing and editing • Responsible for providing or supervising medical monitoring activities for all human clinical trials including support of adverse event reporting and safety management • Responsible for ongoing benefit/risk assessment, monitoring adherence to protocols, helping in the investigation of protocol deviations and providing leadership for monitoring activities related to execution of the protocol or program • Provides medical/clinical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents • Develops relationships with investigators and external organizations and experts to optimize study design and executions. Requirements: • Doctoral level degree (PhD, MD, PharmD, PsyD) required • 6+ years of relevant clinical development experience • Experience in CNS development (Psychiatry or neurology) strongly preferred • Possess strong knowledge of the clinical development process • Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business • Experience in small molecule development • Experienced in data review and analysis, presentations (internal and external) and regulatory writing (IND, CTD sections) • Experienced in building strong relationships within cross-functional groups to achieve results • Proven ability to identify and solve relevant problems related to clinical development • Experience in clinical research for psychiatry, addiction psychiatry, and addiction medicine programs, strongly preferred • Background and proven relevant experience in engaging with clinical trial strategy and trial management • Understanding of the drug development process including technical, business, and regulatory issues • IND experience strongly preferred • Diplomacy and professionalism, ability to build positive relationships both with company leadership and external experts • Able to command respect from peers and subordinates, capable of highly independent work as well as being a team player and role model • Excellent interpersonal, verbal and written communication skills • Proven ability to work remotely and with remote internal and external interdisciplinary teams • Problem-solving and strategic planning skills • Excited by innovative ideas in clinical research space • Self-motivated, resourceful with a 'get the job done' attitude in a fast-paced team environment.
Clinical Research Assistant Adams ClinicalClinical Research AssistantBoston, Massachusetts$24–$26.92 / hourWorking under the direct supervision of a CRC II, CRC III, or Site Manager, the RA assists with operational, administrative, and participant-facing tasks to ensure studies run smoothly and in accordance with ICH-GCP, regulatory requirements, and protocol guidelines. Assist with investigational product (IP) accountability tasks as needed and where applicable, gaining exposure to IP handling, tracking, and documentation under the direct supervision of CRC staff, while ensuring adherence to protocol and site SOPs.
Head, PV and Regulatory QA CSL Behring LLCHead, PV and Regulatory QAWaltham, MAAudit Strategy: Own the long-term, risk-based audit strategy aligned with GVP Module IV; deliver annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors. Your role bridges strategic oversight with hands on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business.
Clinical Research Finance & CTMS Specialist Gastro HealthClinical Research Finance & CTMS SpecialistFramingham, MAPartner with site staff to ensure completed visits, procedures, stipends, screen failures, unscheduled visits, and protocolrequired activities are properly documented and financially captured. This role will report to the Finance Department, while working closely with Clinical Research leadership,site managers, coordinators, investigators, sponsors, CROs, and external financial partners.
Provider Clinical Operations Consultant, Senior Manager PricewaterhouseCoopers LLPProvider Clinical Operations Consultant, Senior ManagerBoston, MA$124,000–$280,000 / yearPreference for at least one of the following fields of study: Accounting, Actuarial Science, Analytics/Data Science, Business Administration/Management, Computer Science/Information Systems, Economics, Engineering, Finance, Government/Public Policy, Health Administration/Public Health, Mathematics/Statistics, Operations/Supply Chain, Organizational Management/Behavior, Risk Management/Insurance. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy .
Clinical Trial Manager Frontier Medicines CorpClinical Trial ManagerBoston, MADirector, Clinical Operations, you will serve as a key operational contact for our CROs and trial sites, helping drive feasibility assessments, site selection, start-up, maintenance, and close-out. This is a hybrid role based in our Boston, MA office, with an expectation of 2-3 days per week onsite, plus periodic travel to trial sites and CRO/vendor meetings as needed.
Director, Clinical Program Quality & Excellence (CPQE), TAU 3316 Takeda Development Center AmericasDirector, Clinical Program Quality & Excellence (CPQE), TAUMassachusettsAs Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality leadership across clinical assets, driving a risk-based quality management approach that enhances program performance, strengthens regulatory confidence, and supports faster delivery of innovative therapies to patients. You will influence key portfolio decisions by providing insights on emerging risks, critical quality issues, and mitigation strategies, while leading inspection readiness across Study Execution Teams and ensuring compliance with global GCP and regulatory expectations.
Fellow in Human-Machine Interface Clinical Research - Bionics Lab Harvard UniversityFellow in Human-Machine Interface Clinical Research - Bionics LabCambridge, MA$50,000–$70,000 / yearThe Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) Bionics Lab ( https://bioniclab.seas.harvard.edu/ ) is seeking a highly motivated Fellow with a background in Biomedical Engineering, Mechanical Engineering, or Neural Engineering to join our interdisciplinary research team. You will work at the intersection of neuroscience, engineering, and clinical science, gaining hands-on experience with human subject research, robotics, and electrophysiological data analysis, while contributing to impactful translational research.
Clinical Research Nurse (PRN) Adams ClinicalClinical Research Nurse (PRN)Watertown, Massachusetts$45,000–$55,000 / yearThis position will also involve general research-related responsibilities like facilitating the informed consent process, administration of screening procedures, data entry, maintenance of regulatory binders, and other nursing functions as required in support of the clinical trial. As a member of our clinical team, you will work under the supervision of our physician principal investigators and clinical nurse manager on the conduct of pharmaceutical-sponsored clinical trials in accordance with FDA regulations and GCP guidelines.
Clinical Research Enrollment Assistant Adams ClinicalClinical Research Enrollment AssistantBoston, Massachusetts$24–$30 / hourThis role focuses on the hands-on execution of essential administrative and clinical tasks—such as scheduling, preparing visit materials, supporting participant flow, maintaining source documentation, and completing timely data entry—to ensure efficient site operations and high-quality study conduct. The enrollment RA works closely with the enrollment coordinators to provide insights that inform clinical judgment on participant eligibility and study suitability and assists with screening activities and accurate documentation in compliance with ICH-GCP, study protocols, and regulatory requirements.
Senior Director, Clinical Data Management Amylyx Pharmaceuticals IncSenior Director, Clinical Data ManagementCambridge, MARemote$245,000–$276,000 / yearThe Senior Director will build and scale internal capabilities while transitioning from a predominantly outsourced model, establishing the systems, processes, and organizational infrastructure necessary to support late-stage development programs and future commercial operations. This role will define and execute the long-term vision for data management across the clinical development portfolio, ensuring the delivery of high-quality data to support regulatory submissions and key business decisions.
Clinical Research Director SanofiClinical Research DirectorCambridge, MA$206,250–$343,750 / yearParticipates and contributes to regulatory and safety documents and discussions: Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
Senior Director, Clinical Operations Kymera Therapeutics IncSenior Director, Clinical OperationsWatertown, MA$235,000–$330,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. How you'll make an impact: The Senior Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for the Phase 3 program of a high priority immunology program, KT-621.
Clinical Research Coordinator Peregrine TeamClinical Research CoordinatorBoston, MAPeregrine Team is seeking a Clinical Research Coordinator to support clinical trial operations for a leading pharmaceutical organization. Coordinate day-to-day clinical trial activities, including patient scheduling and follow-ups.
Scientist I / Scientist II, Computational Protein Design Generate BiomedicinesScientist I / Scientist II, Computational Protein DesignSomerville, MassachusettsThe ideal candidate combines deep structural intuition with a demonstrated ability to rapidly assess and apply protein design methods and metrics across diverse design problems, thinks in terms of reusable capabilities, benchmarks, and feedback loops across applications, and uses modern generative models and experimental readouts to guide iterative design cycles across modalities. This role sits at the intersection of machine learning, structural biology, and therapeutic development, where you will stay at the leading edge of internal and external models for de novo protein design and systematically benchmark, integrate, and apply them within tightly integrated design–build–test–learn cycles to advance our therapeutic pipeline and impact patients' lives.
Clinical Research Director - Immunology And Inflammation SanofiClinical Research Director - Immunology And InflammationCambridge, MA$206,250–$343,750 / yearThe Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, Solid Organ Transplant focus, is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
["Regulatory Coordinator - M Dougan Lab","Regulatory Coordinator - M Dougan Lab"] Dana-Farber Cancer Institute["Regulatory Coordinator - M Dougan Lab","Regulatory Coordinator - M Dougan Lab"]Boston$55,530–$61,700 / yearThis position will work collaboratively with a variety of personnel atall levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project.
Clinical Research Director - Immunology and Inflammation SanofiClinical Research Director - Immunology and InflammationCambridge, MA$206,250–$343,750 / yearThe Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, Solid Organ Transplant focus, is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
Supervisor MRI Imaging Operations $20K Sign-On Incentive Dana-Farber Cancer Institute IncSupervisor MRI Imaging Operations $20K Sign-On IncentiveMA$127,200–$140,400 / yearWorking in close coordination with the Imaging Manager and serving as a subject matter expert, the IS ensures their specific modality and location meet all regulatory and accreditation requirements issued by agencies that include, but not limited to the Centers for Medicare and Medicaid Services, American College of Radiology, The Joint Commission, and the Massachusetts Department of Public Health Radiation Control Program. The responsibilities include coordination of patient scheduling and work flow, managing staffing assignments, providing oversight of operational activities, facilitating clinical research and educational activities, ensuring regulatory and accreditation compliance, participation in the development and achievement of departmental goals, and leads Quality Assurance/Quality Improvement activities.