Director of Operations TekProDirector of OperationsBillerica, MassachusettsWe are a small but highly capable team, and we’re seeking an experienced Operations Director to drive manage global supply chain coordination, oversee day-to-day operations and elevate our quality systems. This is a critical leadership role for a hands-on, results-driven Operations Manager who can oversee and optimize the company’s end-to-end supply chain, quality assurance, vendor management, and planning.
Global Managed Access Manager LancesoftGlobal Managed Access ManagerWaltham, MA$1Job Description: Work with internal stakeholders to provide operational leadership for CLIENT oncology expanded access/compassionate programs including plans and strategies for footprint, drug supply, regulatory coordination, physician oversight, vendor set up and management, safety reporting, and other related activities accordance with CLIENT Policies and SOPs. Establish strong relationships with all stakeholders, including Global Medical Affairs colleagues, Supply team, LOCs, physicians, program managers, regulatory and safety teams as well as external vendors.
Senior Product Manager, Medical Device Aesthetics AtriumSenior Product Manager, Medical Device AestheticsMarlborough, MA$145,000–$195,000 / yearIn this role, the individual acts as the central driver of category strategy and execution, collaborating closely with Sales, Marketing, Clinical Affairs, Regulatory, Operations, Service teams, physicians, and Key Opinion Leaders (KOLs) to expand market adoption, uncover growth opportunities, and meet business goals. The Senior Product Manager, Medical Device Aesthetics spearheads significant cross-functional projects, acts as the go-to expert for the product category, and supports the Director of Product Management in carrying out broader portfolio strategies.
Senior Clinical Trial Manager Eight Sleep IncSenior Clinical Trial ManagerBoston, MA$140,000–$175,000 / yearThis is a hands-on, operationally intense position for someone who knows how to stand up a study from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, and drive studies to completion on time and on budget. Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.
Clinical Project Manager Relay Therapeutics IncClinical Project ManagerCambridge, MA$102,000–$145,000 / yearDevelop and maintain strong working relationships with internal and external stakeholders (cross-functional team members, Contract Research Organizations (CROs), external experts, and clinical site staff), ensuring high-quality services are executed in a timely and cost-effective manner. Experience managing global clinical trials and study teams across all stages (startup-closeout) of phase I-III studies and a strong working knowledge of GCP/ICH and other applicable regulations/guidelines required.
Program Manager, New Product Development TransMedics Group, Inc.Program Manager, New Product DevelopmentAndover, MA$147,200–$183,600 / yearLead the creation and management of comprehensive program schedules, including detailed Gantt charts and Work Breakdown Structures (WBS); analyze critical paths, key workstreams, and interdependencies to proactively manage timeline risks. We are seeking a highly motivated and experienced Program Manager to lead cross-functional teams in the development and commercialization of innovative medical device products, including capital equipment, disposable components, and software-enabled systems.
Senior Manager, GMP QA Operations Dyne TherapeuticsSenior Manager, GMP QA OperationsWaltham, MA$160,000–$195,000 / year4+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry, preferably with experience overseeing CMO/CDMO organizations. Leads tactical GMP QA operations supporting manufacturing, testing, deviation investigations, and CAPA implementation to enable compliant product disposition for clinical development and future commercialization.
Clinical Project Associate Relay Therapeutics IncClinical Project AssociateCambridge, MA$61,000–$87,000 / yearYour Role: Partner with Clinical Project Managers to support the day-to-day operations of clinical trial execution, with a focus on site start-up, study participant enrollment, clinical monitoring, GCP and protocol compliance, from the clinical sites, CROs and vendors. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology.
Clinical Research Budget & Effort Analyst Actalent IncClinical Research Budget & Effort AnalystBrookline, MA$36.10–$40.62 / hourWe are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Global Clinical Department Strategy Expert SanofiGlobal Clinical Department Strategy ExpertWaltham, MA$178,500–$257,833.33 / yearExperience: MD with specialization in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field; or PhD in a life science area (Biology, Immunology, Pharmacology, or related field) with extensive clinical development experience. Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
Senior Clinical Research Associate (level dependent on experience) CTISenior Clinical Research Associate (level dependent on experience)Boston, MassachusettsFor that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward. To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance.
Manager, RBQM ModernaTXManager, RBQMCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Support study- and program-level risk assessments, including identification of Critical to Quality (CTQ) factors, development of Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs), and tracking of mitigation actions.
Director of Behavioral Health Fenway HealthDirector of Behavioral HealthBoston, MA$140,000–$175,000 / yearDirectly supervises the Medical Director of Behavioral Health, Manager of Outpatient Behavioral Health, Manager of Integrated Behavioral Health, Manager of Clinical Training and Education, Violence Recovery Program leadership, and other assigned department managers and supervisors. Minimum of five (5) years of progressively responsible leadership experience leading behavioral health programs, multidisciplinary clinical teams, or integrated behavioral health services, preferably across multiple clinical sites.
Director, Site Performance & Strategy - Cardiology Iterative HealthDirector, Site Performance & Strategy - CardiologyCambridge, MA$170,000–$215,000 / yearIf you've spent years building frameworks for other people's businesses in consulting, or running ops at a startup where you had to build the plane while flying it, this is where that skill set gets applied to a mission that matters: accelerating clinical trials that bring new treatments to patients faster. Serving as the operational owner of our centralized site solutions—including pre-screening, regulatory support, and eSource—you will partner cross-functionally to optimize workflows, scale capabilities, and improve site and sponsor outcomes.
Principal Carelon Research Biostatistician Elevance HealthPrincipal Carelon Research BiostatisticianNewton, Massachusetts$136,000–$234,600 / yearThis researcher partners with investigators, research sponsors, academic institutions, and cross-functional project teams to design studies, develop statistical methodologies, oversee analytical execution, and communicate scientific findings that advance externally funded clinical research programs. Experience designing clinical research studies, developing sample size calculations, statistical analysis plans, outcome measures, and advanced statistical methodologies including survival analysis, causal inference, and experimental design preferred.
Director, Global Program Management - Clinical Oncology 3316 Takeda Development Center AmericasDirector, Global Program Management - Clinical OncologyBoston, MassachusettsCore responsibilities include: Providing strategic direction and matrixed leadership in translating the integrated Global Product Team (GPT) asset strategy into an efficiently executable plan; predicting and planning solutions to achieve program goals and objectives; driving clarity and removing barriers to ensure team success; interfacing with management and influencing decision-making, proactive management and mitigation of development risks, and supporting appropriate communication and interface with PRC governance. Provides strong global program management and matrixed leadership to global, cross-functional, cross-divisional teams to drive development and deliver results in early to late-phase major development and/or lifecycle management programs (including established/marketed products) to meet Takeda strategic objectives.
Director, Pharmacovigilance Beam Therapeutics IncDirector, PharmacovigilanceCambridge, MA$210,000–$260,000 / yearWork closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents; leading cross functional teams to assess safety signals; preparing action and communication plans to mitigate/manage product risks; responding to safety related regulatory requests; developing and maintaining product risk management plans. The Director of Pharmacovigilance will contribute to a full range of pharmacovigilance activities including but not limited to the oversight and management of safety reports and safety data, signal management activities, PV organization and process development, inspection readiness, PV vendor management, and operational support for Beam products throughout the lifecycle.
Clinical Director, Askia The Dimock CenterClinical Director, AskiaRoxbury, MA$100,000–$115,000 / year3-5 years of progressively responsible management experience; at least three years of post LMHC/LICSW/LADC1 experience; at least one year of clinical supervision in a substance use treatment environment and at least two years of direct clinical practice experience; Demonstrated ability and experience in managing multidisciplinary staff; proven leadership in improving systems; knowledge of current trends in substance use/mental health care and experience in developingsuccessful operational systems to meet identified needs; experience and clear communication skills withregulatory, accreditation, funding, managed care and referral entities. Reporting to the Chief Behavioral Health Officer and working in close partnership with the Program Director, the Clinical Director oversees all clinical components of the program, including patient care, service utilization, admissions, continued stay reviews, and discharge planning.
Associate Director, Quality Operations Amylyx PharmaceuticalsAssociate Director, Quality OperationsCambridge, MARemote$172,000–$194,000 / yearProvide QA review and approval on quality technical agreements, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans. Lead or participate in regular meetings internally and externally as CMC Quality SME to ensure Amylyx’s quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.
Associate Director, Quality Operations Amylyx Pharmaceuticals IncAssociate Director, Quality OperationsCambridge, MARemote$172,000–$194,000 / yearProvide QA review and approval on quality technical agreements, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans. Lead or participate in regular meetings internally and externally as CMC Quality SME to ensure Amylyx's quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.