NewSenior Director, Clinical Operations Keros TherapeuticsSenior Director, Clinical OperationsLexington, MA$253,000–$300,000 / yearWith a focus on developing differentiated product candidates that are designed to alter TGF- signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. As the leader of the cross-functional Clinical Program Team, the Senior Director Clinical Operations (SDCO) will lead the planning and execution strategy of assigned clinical trials to achieve overall program and corporate objectives.
Senior Director, Clinical Operations Alira HealthSenior Director, Clinical OperationsBoston, MA$175,000–$195,000 / yearThe Senior Director, Clinical Operations provides oversight of Clinical Development Operations, Nonclinical Development, Regulatory Affairs, Quality Assurance, Manufacturing/CMC Operations, and Program Management, while partnering closely with R&D, Finance, Investor Relations, Legal, and the CEO to ensure efficient execution of corporate objectives. This role is accountable for translating the clinical operations strategy into operational execution, driving cross-functional alignment, ensuring compliance with global regulatory requirements, maintaining operational excellence, and supporting the advancement of the Company's development pipeline from research through commercialization.
NewSr. Manager, Regulatory Operations (Publishing) Replimune Group, Inc.Sr. Manager, Regulatory Operations (Publishing)Woburn, MA$137,500–$168,500 / yearThis role is a key member of the Regulatory Operations team and will partner closely with Regulatory Affairs, Medical Writing, Clinical Operations, Biostatistics, Data Management, Quality, and external service providers to ensure the successful delivery of high-quality, compliant submissions to global health authorities. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
Sr. Associate/Manager Project Management & Operations Oruka Therapeutics, Inc.Sr. Associate/Manager Project Management & OperationsWaltham, MA$146,000–$161,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.
Manager, User Guide Strategy and Operations (Hybrid-Acton, MA or San Diego, CA) Insulet CorpManager, User Guide Strategy and Operations (Hybrid-Acton, MA or San Diego, CA)Acton, MA$144,500–$216,800 / yearThe manager leads a team of senior independent contributors and contract technical writers while serving as the primary user guide representative for cross-functional stakeholders, including Product, Engineering, Medical Affairs, Regulatory Affairs, Human Factors, Quality, and external partners. The Manager, User Guide Strategy and Operations serves as a senior leader within the user guide function and is responsible for portfolio ownership, people leadership, delivery execution, and operational excellence across a portfolio of Omnipod products and programs.
Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery LancesoftSenior Manager, Integrated Clinical Trial Data Process Excellence and DeliveryCambridge, MA$75Facilitate cross-functional workshops and subject matter expert interviews to gather requirements, document process steps, clarify roles and handoffs, and confirm proposed content. Experience facilitating cross-functional workshops and subject matter expert discussions to gather requirements, clarify roles and handoffs, and confirm proposed process content.
Director of Clinical Research Eight Sleep IncDirector of Clinical ResearchBoston, MAYou will also own program management across the full breadth of the clinical teams verticals - hardware studies, AI/ML development studies, and women's sleep studies - while also acting as Eight Sleeps public-facing voice on the science of sleep, from peer-reviewed publications to press and podcast appearances. Provide scientific input on marketing claims, press releases, and journalist articles by reviewing web, social, and app content for accuracy and ensuring every public-facing claim and document is backed by data.
Clinical Trial Manager II Summit Therapeutics IncClinical Trial Manager IICambridge, MA$122,000–$145,000 / yearHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Drafts, reviews and manages study related plans, processes including Informed Consent Forms, Investigator agreements (CTA), CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring as delegated.
Sr. Manager, Clinical Quality Assurance Summit Therapeutics IncSr. Manager, Clinical Quality AssuranceCambridge, MA$158,000–$185,000 / yearHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. In collaboration with the Global RD/PV QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections.
Associate Director Drug Product Technical Operations Vor BioAssociate Director Drug Product Technical OperationsBoston, MA$170,000–$195,000 / yearDrug Product and Combination Product Integration: Partner closely with the Combination Product Development Lead to ensure alignment between drug product characteristics, primary container systems, prefilled syringes, needle safety devices, autoinjectors, fill-finish processes, device performance, and product presentation requirements. This role will have end-to-end accountability for drug product manufacturing from late-stage development through commercialization, including manufacturing strategy, technology transfer, aseptic fill-finish, process validation, lifecycle management, commercial readiness, and Drug Product Module 3 content.
Clinical Research Associate - I&I or Oncology (In house) Monte Rosa Therapeutics IncClinical Research Associate - I&I or Oncology (In house)Boston, MAThe CRA will also serve as an in-house sponsor representative overseeing CROs and third-party monitoring vendors, ensuring delegated activities meet protocol, GCP, quality, and timeline requirements. The Clinical Research Associate (CRA) supports clinical trial quality, compliance, and execution through site monitoring, study startup, data oversight, and regulatory documentation.
Vice President, Clinical Development Remix TherapeuticsVice President, Clinical DevelopmentWatertown, MA$293,000–$358,000 / yearWe are a clinical-stage biopharmaceutical company that has pioneered a new class of small molecule medicines targeting the RNA splicing machinery — correcting the disease-causing errors that drive ACC and other serious conditions at their source. Reporting directly to the Chief Medical Officer at our Watertown, MA headquarters, you will work alongside senior leadership at a pivotal moment in the company's clinical trajectory, with direct visibility into how key development decisions get made.
Director, Radiation Oncology Operations Tufts MedicineDirector, Radiation Oncology OperationsStoneham, MA$162,773.52–$207,541.52 / yearDrive updates to radiation oncology model to ensure high-quality, safe patient care and efficient workflows across radiation oncology department, across four sites of care including both AMC and community settings. Will oversee operations at four radiation oncology sites for the Tufts Medicine system: Tufts Medical Center/Boston, Tufts Medical Center /Framingham, Melrose-Wakefield Hospital/Stoneham, and Lowell General Hospital/Lowell.
Senior Clinical Trial Manager (Contract) Centessa Pharmaceuticals PlcSenior Clinical Trial Manager (Contract)Boston, MA$70–$100 / hourCentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. This role is a temporary position with the potential to convert to a permanent role, accountable for study delivery, including operational strategy, timelines, budget, quality, vendor oversight, risk management, and inspection readiness.
Senior Clinical Trial Manager Contract Centessa Pharmaceuticals PlcSenior Clinical Trial Manager ContractBoston, MA$70–$100 / hourCentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. This role is a temporary position with the potential to convert to a permanent role, accountable for study delivery, including operational strategy, timelines, budget, quality, vendor oversight, risk management, and inspection readiness.
Operations Process Leader (OPL) Band 6 Thermo Fisher Scientific IncOperations Process Leader (OPL) Band 6Plainville, MA$83,300–$125,000 / yearA day in the Life: Lead operational production readiness for late clinical stage and commercial manufacturing of new products ensuring robust implementation of new production capabilities that reliably and sustainably meet and/or exceed operational, quality, and cost targets. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Head of Clinical Process and Standards Galderma Group AGHead of Clinical Process and StandardsBoston, MA$200,000–$265,000 / yearWhere pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.
Senior Clinical Trial Manager Summit Therapeutics IncSenior Clinical Trial ManagerCambridge, MA$158,000–$185,000 / yearHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Drafts, reviews and approves study-related plans, processes, and documents including Informed Consent Forms, Investigator Agreements (CTA), CRFs, CRF Guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management plans, and safety monitoring activities.
Associate Director, Clinical Quality Assurance Centessa Pharmaceuticals PlcAssociate Director, Clinical Quality AssuranceBoston, MA$140,000–$180,000 / yearCentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.
Operations & Office Manager for a Mental Health Clinic Ellie Mental Health - 221Operations & Office Manager for a Mental Health ClinicFramingham, MAPart timeIf you’re the kind of person who finds joy in turning chaos into checklists, loves making systems run like clockwork, and can juggle a ringing phone while keeping a smile in your voice, we want to meet you! · Serve as a liaison between administrative staff, clinicians, and clients to resolve scheduling issues, billing questions, and maintain client satisfaction.