NewPharmacovigilance Scientist Oruka TherapeuticsPharmacovigilance ScientistWaltham, MassachusettsRemoteOruka’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. Cross-Functional Collaboration: Works closely with clinical operations, regulatory affairs, medical affairs, data management, bioinformatics and project management teams to ensure comprehensive safety oversight.
Associate Director, Campus Laboratory and Benchtop Systems Bristol-Myers Squibb CoAssociate Director, Campus Laboratory and Benchtop SystemsMA$186,070–$225,467 / yearThe Devens Campus Laboratory and Benchtop Systems Associate Director serves as the campus-wide lead for all laboratory informatics and benchtop instrument systems, providing strategic leadership and accountability for the deployment, validation, integration, and lifecycle management of laboratory technologies supporting GxP and non-GxP research and quality operations across the site. Additionally, the Associate Director leads and empowers the campus Laboratory and Benchtop Systems team, including overseeing instrument qualification and laboratory informatics activities, and partnering with enterprise platform teams to support site laboratory priorities.
Regulatory Specialist Lahey Hospital and Medical CenterRegulatory SpecialistBoston, MA$60,008–$88,005 / yearJob Description: Job Summary: The Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC) supports clinical research and provides infrastructure and services to 12 individual cancer disease programs: AIDS Oncology, Breast Oncology, Cutaneous Oncology, Experimental Therapeutics, Gastrointestinal Oncology, Genitourinary Oncology, Gynecological Oncology, Hematological Malignancies/Bone Marrow Transplant, Radiation Oncology, Renal Oncology, Thoracic Oncology, and Thrombosis/Benign Hematology. Essential Responsibilities: Prepare and submit applications, including preparation of consent forms to the DFHCC IRB on all cancer center clinical trials (industry, cooperative groups and PI initiated studies), and respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients.
Senior Director, Medical Affairs Editas MedicineSenior Director, Medical AffairsCambridge, MA$280,000–$325,000 / yearThe primary focus of this role is to lead medical and scientific strategic planning and operational execution of core medical affairs activities from early-clinical phase through lifecycle management for our lead in vivo development candidate, EDIT-401, a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. As the Senior Director, Medical Affairs you will: Develop and lead Medical Affairs strategies including medical communications, engagement with opinion leaders, data dissemination, and external collaborations.
Clinical Education Specialist StemWaveClinical Education SpecialistWoburn, Massachusetts$100,000–$180,000 / yearStemWave is a fast-growing medical device company based in Massachusetts, pioneering orthopedic shockwave technology in the U.S. Our technology is helping change the lives of practitioners and patients by advancing healing and expanding access to effective, non-invasive pain management solutions. Doctoral or advanced clinical degree from an accredited program: Doctor of Physical Therapy (DPT), Doctor of Chiropractic (DC), Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), or Master's/Doctoral degree as a Nurse Practitioner (NP).
Application Analyst Lil - Healthy Planet Certified Tufts MedicineApplication Analyst Lil - Healthy Planet CertifiedBurlington, MARemote$101,084.26–$128,878.21 / yearIn addition, this role focuses on performing the following Client Applications Support duties: Designs, develops, implements, and updates internal IT applications in accordance with specifications and business needs., designs, codes, tests, and debugs computer programs, and prepares systems documentation and training. Minimum Qualifications: High school diploma or equivalent and ten (10) years of relevant experience OR Associate degree in information technology, finance, clinical field, or related field and eight (8) years of relevant experience OR Bachelor's degree in information technology, finance, clinical field, or related field and six (6) years of relevant experience.
Senior Project Manager - Ostro Implementation Veeva SystemsSenior Project Manager - Ostro ImplementationBoston, MA$90,000–$150,000 / yearUnlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. Manage full-lifecycle software implementation projects from kickoff to go-live, driving clear client communication, proactive risk mitigation, and team accountability to maintain strict timelines.
Clinical Research Coordinator II - Lowell General Hospital, Cancer Center - On-Site Tufts MedicineClinical Research Coordinator II - Lowell General Hospital, Cancer Center - On-SiteLowell, MA$47,924.24–$59,894.75 / yearJob Profile Summary: The Clinical Research Coordinator supports clinical trials by recruiting and screening participants, conducting informed consent, and coordinating all protocol‑required visits, procedures, and follow‑up. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.
Neuro-Immunologist Tufts MedicineNeuro-ImmunologistBoston, MA$258,000–$265,000 / yearPosition Overview: You will be responsible for expanding a comprehensive Neuro-Immunology Service at Tufts Medical Center, delivering the highest quality, multidisciplinary care for patients with multiple sclerosis and autoimmune neurological disorders (including neuroinfectious diseases with immune sequelae). Responsibilities will include conducting thorough evaluations, implementing and managing disease-modifying therapies, collaborating with a multidisciplinary team to address patient needs with a focus on symptom management, rehabilitation, and lifestyle modifications, and engaging in ongoing research and clinical trials to advance neuro-immunological care.
Global Development Lead, Internal Medicine (Sr. Director) Pfizer IncGlobal Development Lead, Internal Medicine (Sr. Director)Cambridge, MA$214,900–$358,100 / yearResponsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the pediatric investigation plan / pediatric study plan and associated protocol design documents working closely with individual trial clinicians to ensure trial feasibility and optimized operational execution. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Global Development Lead, Internal Medicine (MD, Sr. Director) Pfizer IncGlobal Development Lead, Internal Medicine (MD, Sr. Director)Cambridge, MA$274,500–$457,500 / yearResponsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the pediatric investigation plan / pediatric study plan and associated protocol design documents working closely with individual trial clinicians to ensure trial feasibility and optimized operational execution. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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.
Senior Manager/Associate Director, Portfolio & Strategy Operations Relay Therapeutics IncSenior Manager/Associate Director, Portfolio & Strategy OperationsCambridge, MABuilt 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. The Opportunity: As the Senior Associate/Associate Director of Portfolio and Strategy Operations, you will help ensure flawless operation of activities for a first-in-class program as it moves through clinical development while reporting to the Director of Portfolio Strategy and Operations.
Director of Clinical Affairs Eight Sleep IncDirector of Clinical AffairsBoston, MA$200,000–$250,000 / 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, establish and oversee any study committees (EC, DSMB, etc.), prepare for FDA submissions and audits, and drive studies to completion on time and on budget. 10+ years of hands-on clinical operations experience, with at least 5 years of experience in leadership roles, executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products.
NewSenior Cloud Operations Engineer, Infrastructure Pegasystems IncSenior Cloud Operations Engineer, InfrastructureWaltham, MA$102,400–$153,200 / yearYou'll collaborate closely with Engineering, Cloud Engineering, Security, and Customer Support to deliver best‑in‑class infrastructure reliability for mission‑critical customer environments. For positions requiring access to technical data subject to export control regulations such as this, Pegasystems may need to obtain export license approval from the U.S. Government and EU Authorities for certain individuals.
Manager, CMC Project Management Crescent BiopharmaManager, CMC Project ManagementWaltham, Massachusetts$140,000–$180,000 / yearWorking closely with Technical Operations - including Drug Substance, Drug Product, Analytical Development, Regulatory CMC, Quality, Supply Chain and external partners, this role leads integrated project planning, facilitates cross-functional alignment, manages risks and timelines, and enables successful delivery of CMC milestones in support of regulatory and development objectives. Lead cross-functional CMC project management for clinical-stage development programs, developing and maintaining integrated project plans, timelines, critical path activities, milestones, risks, and decision logs.
Executive Director, Medical Affairs Operations & Strategic Excellence Viridian Therapeutics IncExecutive Director, Medical Affairs Operations & Strategic ExcellenceWaltham, MAThis individual will facilitate a broad range of strategic and tactical initiatives across all functional areas, including Independent Medical Education (IME), Investigator-Sponsored Trials (ISTs), Medical Communications, Medical Information, Health Economics and Outcomes Research (HEOR), Expanded Access Programs (EAP), and the field medical team. This role will focus on refining the medical affairs strategy, scientific platform and key messaging; enhancing training programs; contracting with vendors to implement platforms and services; ensuring policies and procedures are in place and being followed; supporting key opinion leader (KOL) engagement initiatives, and reporting on KPIs.
Audiologist II Boston Children's HospitalAudiologist IIBoston, MAAssists in maintaining efficiency of clinical operations, including day to day schedule coordination, provision of unscheduled services to patients having urgent needs, support to other staff in implementing clinical assignments, maintenance of up to date consignment stock of hearing technology with liaison to manufacturers' representatives; equipment calibration; organization of equipment and supplies. Coordinates implementation of case management plan, including communication with physicians, participation in interdisciplinary staffing, telephone and paperwork assistance to the family in obtaining funding for and fitting of hearing technology, coordinating return visits with appointments in related services, and facilitating contacts with outside services.
Executive Medical Director, SERM Sarepta Therapeutics IncExecutive Medical Director, SERMCambridge, MA$313,200–$391,500 / yearThe Executive Medical Director, SERM will function in a company matrix team environment interacting with several key stakeholder groups including Nonclinical, Research, Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs, Quality Assurance, and Commercial. Competent in safety reviews of postmarketing safety documents including spontaneous reports and other individual case safety reports (ICSRs), periodic safety reports, risk management plans, company core data sheet.
NewPrincipal Medical Writer Alnylam Pharmaceuticals IncPrincipal Medical WriterCambridge, MA$172,000–$232,800 / yearProvide medical writing subject matter expertise and leadership to project teams and collaborate with the Medical Writing line management to ensure proper planning and resourcing for upcoming project team writing deliverables. Independently plan, coordinate, develop, update, and revise key documents, including clinical protocols, investigator brochures, clinical study reports, integrated efficacy and safety summaries, and related documents.