Associate Director, Global Safety Lead - Remote Agios PharmaceuticalsAssociate Director, Global Safety Lead - RemoteBoston, MARemote$185,369–$308,948 / yearo The current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. • Proactively assesses and evaluates the clinical implications of safety data from all sources in order to understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing settings as appropriate.
Senior Scientist, Safety Assessment Prime Medicine, Inc.Senior Scientist, Safety AssessmentCambridge, MA$145,000–$177,000 / yearD. in toxicology or a related field with 6+ years of pharma/biotech experience in nonclinical safety assessment, or an M.S. in toxicology or a related field with 10+ years of experience in nonclinical safety assessment, the ability to work independently, provide domain expertise and leadership, as well as cross-functionally in a fast-paced, matrixed environment with a positive, flexible attitude. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Associate Director, Medical Review Lead, MSRM - Remote Agios PharmaceuticalsAssociate Director, Medical Review Lead, MSRM - RemoteBoston, MARemote$185,369–$308,948 / yearThe current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This role provides oversight of medical review for Individual Case Safety Reports (ICSRs) across investigational and marketed products, ensuring medical accuracy, regulatory compliance, and high-quality safety data to support pharmacovigilance and risk management activities.
Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) Xenon PharmaceuticalsDirector/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)Needham, MassachusettsThe successful candidate will author safety documents, reviews safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, performs QC, and, when necessary, assists in responding to information requests from Health Authorities for Xenon products, participate in cross-functional Safety Risk Management Team (SRMT) meetings and collaborate with colleagues in Clinical Development, Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, Medical Affairs, non-clinical safety lead, QA and Legal departments. • Support and review safety-related documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-related documents, and responses to ad-hoc information requests by Health Authorities and internal stakeholders.
Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV) Hemab ApSVice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV)Boston, MADevelop processes for and provide safety medical oversight of safety surveillance and benefit risk assessments, including medical review of ICSRs, signal management activities, safety analyses, benefit risk profile development and monitoring, and risk mitigation strategies. This role requires a hands-on leader with robust medical and operational expertise, a strong understanding of global regulatory requirements, and the ability to design and oversee a robust fit-for-purpose safety system that scales with company growth to support excellence in Drug Safety & Pharmacovigilance as a critical part of our mission.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MAThis role is responsible for establishing and executing global safety strategy across early- and mid-stage clinical programs, with particular focus on immune-mediated toxicities, oncology risk management, and complex benefit-risk assessment. The Director of Drug Safety & Pharmacovigilance provides strategic and hands-on leadership for pharmacovigilance activities supporting a clinical-stage biotech pipeline in inflammatory and oncology diseases.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics, IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MassachusettsFull timeThis role is responsible for establishing and executing global safety strategy across early‑ and mid‑stage clinical programs, with particular focus on immune‑mediated toxicities, oncology risk management, and complex benefit–risk assessment. Overview: The Director of Drug Safety & Pharmacovigilance provides strategic and hands‑on leadership for pharmacovigilance activities supporting a clinical‑stage biotech pipeline in inflammatory and oncology diseases .
Senior Specialist, Drug Safety CRISPR Therapeutics AGSenior Specialist, Drug SafetySouth Boston, MA$105,000–$115,000 / yearThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Senior Manager, Drug Safety CRISPR Therapeutics AGSenior Manager, Drug SafetySouth Boston, MA$140,000–$155,000 / yearThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Associate Medical Director, Global Drug Safety Biogen IncAssociate Medical Director, Global Drug SafetyCambridge, MA$194,000–$267,000 / yearRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including: • review and analysis of safety data • design of clinical trials • identification and investigation of safety signals • management of benefit-risk profile for assigned compounds and products.
Senior Specialist, Drug Safety CRISPR TherapeuticsSenior Specialist, Drug SafetySouth Boston, MassachusettsThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Principal Scientist, Nonclinical Drug Safety Program Discovery Merck & Co IncPrincipal Scientist, Nonclinical Drug Safety Program DiscoveryCambridge, MA$176,200–$277,300 / yearThey are responsible for 1) providing risk assessments for targets, 2) de-risking strategies for discovery programs and 3) collaborating with NDS staff at other sites to execute on the appropriate studies to support selection of therapeutic targets, and the identification and development of new drug candidates. The Discovery Program Leader is responsible for defining and overseeing the NDS strategy for programs in all modalities (including small molecules, peptides, biologics and ADC programs) from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies.
Senior Manager, Drug Safety CRISPR TherapeuticsSenior Manager, Drug SafetySouth Boston, MassachusettsThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs) SanofiGlobal Project Head, Solid Tumor Antibody Drug Conjugates (ADCs)Cambridge, MA$232,500–$335,833.33 / yearThe GPH will collaborate with the Principal Clinical Lead (PCL) and Global Project Manager (GPM) to lead the cross-functional GPT (which includes translational, regulatory, drug manufacturing, safety, medical and commercial compound leads), to ensure correct planning and implementation of end-to-end compound strategy. Key Responsibilities: The Global Project Head (GPH) drives worldwide clinical development and life cycle management for a late-stage Sanofi Antibody Drug Conjugate (ADC) compound within Solid Tumor Oncology.
Senior Scientist, Medicinal Chemistry, Integrated Drug Discovery SanofiSenior Scientist, Medicinal Chemistry, Integrated Drug DiscoveryCambridge, MA$100.50–$145.17 / hourActively participate in medicinal chemistry discussions communicating own science in a clear and precise manner; proactively raise issues which positively influence the direction of program. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products.
VP/SVP of Drug Discovery Deep Origin IncVP/SVP of Drug DiscoveryBoston, MAThis individual will serve as a key scientific and operational leader inside the company, partnering closely with computational scientists, experimental scientists (own lab), platform teams, translational biology, external collaborators, and executive leadership to prioritize programs, guide strategic decisions, and accelerate pipeline execution. This is a critical executive leadership role for a hands-on scientific leader who has spent significant time navigating the realities of drug discovery and development - someone who understands not only what can work scientifically, but what actually translates into successful therapeutic programs.
VP/SVP of Drug Discovery Deep OriginVP/SVP of Drug DiscoveryBoston, MassachusettsThis individual will serve as a key scientific and operational leader inside the company, partnering closely with computational scientists, experimental scientists (own lab), platform teams, translational biology, external collaborators, and executive leadership to prioritize programs, guide strategic decisions, and accelerate pipeline execution. This is a critical executive leadership role for a hands-on scientific leader who has spent significant time navigating the realities of drug discovery and development — someone who understands not only what can work scientifically, but what actually translates into successful therapeutic programs.
Manufacturing Process Owner - Drug Product Formulation (SAP S/4 HANA Enablement) Sun Pharmaceutical Industries LtdManufacturing Process Owner - Drug Product Formulation (SAP S/4 HANA Enablement)Billerica, MA$86,500–$96,500 / yearProcess Design & Operational Enablement: • Lead design, mapping, and optimization of manufacturing processes in consultation with global process owners • Work with Digital/IT to translate operational requirements into SAP S/4HANA configuration • Validate master data from an operations and GMP perspective • Ensure GMP/GxP and data integrity compliance in daily manufacturing execution. Work Conditions: Office Controlled/manufacturing area Physical Requirements: • Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk and hear • Be able to multitask • Operate computer/office machines.
Associate Director, Drug Product Disc Medicine IncAssociate Director, Drug ProductMA$167,000–$205,000 / yearPOSITION OVERVIEW: Reporting to Executive Director, Biologics Drug Product; the Principal Scientist / Associate Director in Biologics Drug Product Development will be responsible for providing leadership for drug product technical elements of assets within the biologics pipeline programs, focusing on antibodies and/or proteins. 10-15 years in the pharmaceutical / biopharmaceutical industry with a minimum of 4-6 years of hands-on experience with early and/or late-stage drug product development programs, such as formulation, process, and/or device development and technology transfer.
NewSenior Scientist, Drug Discovery Biology (Target Biology & MoA) Novartis AGSenior Scientist, Drug Discovery Biology (Target Biology & MoA)Cambridge, MA$98,700–$183,300 / yearDepth in membrane protein biology experience (GPCRs and/or ion channels).Demonstrated hands‑on experimental strength in molecular/cell biology (e.g., interrogation of functional readouts).Evidence of strong hypothesis-driven thinking, experimental troubleshooting, and the ability to translate complex biology into clear next experiments. We are seeking a Senior Scientist to bring deep molecular target biology expertise and rigorous, hypothesis-driven experimentation to support mechanism of action (MoA) deconvolution and target validation in multiple diseases areas.
Drug Product MSAT Scientist I Thermo Fisher Scientific IncDrug Product MSAT Scientist IPlainville, MA$25.60–$38.39 / hourWe 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. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Drug Product MSAT Scientist II Thermo Fisher Scientific IncDrug Product MSAT Scientist IIMA$66,000–$99,000 / yearWe 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. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Senior Director, Bioprocess / Process Development - Pivotal Drug Substance Amgen IncSenior Director, Bioprocess / Process Development - Pivotal Drug SubstanceCambridge, MAIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen's manufacturing network.
Senior Director, Bioprocess / Process Development – Pivotal Drug Substance AmgenSenior Director, Bioprocess / Process Development – Pivotal Drug SubstanceMassachusettsIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen’s manufacturing network.
NewDrug Product, Manufacturing Supervisor Thermo Fisher Scientific IncDrug Product, Manufacturing SupervisorPlainville, MA$83,300–$125,000 / yearWe 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. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Strategy Insights & Planning Consultant - R&D Drug Development Veeva ZS Associates IncStrategy Insights & Planning Consultant - R&D Drug Development VeevaMALeverage knowledge of R&D Products and Platforms (ex: Veeva, Medidata, IQVIA, etc.) to advise on strategic planning, functional data flow, product implementations (ex: configuration, deployment, migration, and GxP testing), R&D stakeholders & processes, and platform ecosystem management; Advise on R&D business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. In lieu of an MBA or PhD, 5-8 years of relevant work experience may substitute; Required: At least 2 years of direct product services/design/implementation/management experience with Veeva Vault Clinical or Veeva Vault Regulator product suites and data.
Material Operations - Drug Product, Supply Chain Senior Specialist (Contract) 29251 Vertex PharmaceuticalsMaterial Operations - Drug Product, Supply Chain Senior Specialist (Contract) 29251Boston, Massachusetts$55–$65 / hourFull timeAgreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. The ideal candidate will have experience performing inventory analytics, inventory/raw material, planning, and forecasting experience in a pharmaceutical environment ( biologics, drug product, cell & gene) .
Non-Clinical Safety Lead - Cambridge, MA UCB SANon-Clinical Safety Lead - Cambridge, MACambridge, MA$168,000–$220,500 / yearYou will thrive in an environment where you can share expertise across functions and global UCB sites, engage with cutting-edge science and build collaborative networks to drive cross-functional success. This role is well suited to an experienced toxicologist-ideally with exposure to gene and cell therapy or other novel modalities-who enjoys working at the interface of science, development strategy, and regulation.
NewSenior Director / Director, Non-Clinical Safety Project Specialist GSK plcSenior Director / Director, Non-Clinical Safety Project SpecialistWaltham, MA$224,400–$374,000 / yearAccountable for the quality of scientific thinking and outputs that characterise non-clinical safety, drug disposition and on-/off-target engagement for potential therapies, integrating data and knowledge into clear project narratives, optimized development plans, regulatory documents and decision-making. Through direct project delivery, cross-functional influence and support of the wider PTM community, enable the safe and efficient progression of medicines through clinical development, approval and, where required, post-market support.
Senior Scientist II - Non-clinical Safety Novo Nordisk ASSenior Scientist II - Non-clinical SafetyLexington, MA$150,000–$190,000 / yearLead multiple projects as subject matter expert, function as project leader for projects comprising multiple experimental activities & coordination of activities to meet deadlines, communicate project updates & experimental results, provide expert-level guidance to experimental plans & data interpretation; may propose & lead external research efforts to support project goals; attend & present at scientific conferences as an NN-subject matter expert; deep understanding of subject matter & demonstrate creative thinking & solutions for addressing critical scientific questions; may supervise junior staff; author internal reports & external publications; recommend, present, & champion new targets or methodologies. Internal relationships include working closely with technical staff & other members of the scientific leadership team; regular collaborations with members of other research departments at Novo Nordisk; & frequent interaction with project managers & other colleagues across global R&D.
NewGlobal Safety Program Lead/Sr Medical Director AlexionGlobal Safety Program Lead/Sr Medical DirectorBoston, MassachusettsLeads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset. Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
Global Safety Program Lead/Sr Medical Director Alexion Pharmaceuticals IncGlobal Safety Program Lead/Sr Medical DirectorBoston, MA$280,895–$421,342 / yearLeads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset. Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
Medical Director, Global Patient Safety AlexionMedical Director, Global Patient SafetyBoston, MassachusettsEvaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required. Representing Alexion GPS at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetings.
Medical Director, Global Patient Safety Alexion Pharmaceuticals IncMedical Director, Global Patient SafetyBoston, MA$249,827.20–$374,740.80 / yearWe would prefer for you to have: 2-3 years safety and risk management experience in the pharmaceutical, biotech or CRO industry Rare, Ultra-Rare or Orphan Disease Area experience Strong verbal and written communication skills including making recommended courses of action to management Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Proficiency in Microsoft Word, PowerPoint and Excel. Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required.
Senior Director, Nonclinical Safety Evaluation ModernaTXSenior Director, Nonclinical Safety EvaluationCambridge, MassachusettsThis role will have specific emphasis and accountability for products in Moderna’s emerging and/or established Systemic IV portfolio (spanning Autoimmune, Immuno-Oncology, and/or Rare Disease), with additional responsibilities to partner with Platform Science teams to support the safety evaluation and optimization of novel and existing technologies, as well as in other therapeutic areas as needed based on evolving business needs. Accountable for the design, execution, critical analysis, and reporting of GLP/non-GLP nonclinical safety in vitro and/or in vivo studies conducted in multiple species under the nonclinical safety assessment umbrella for the assigned therapeutic area(s) via collaborative partnerships with study monitors and program team representatives (e.g., DMPK, bioanalytical, operations, etc.).
Preclinical Safety Profiling Expert, Principal Scientist Novartis AGPreclinical Safety Profiling Expert, Principal ScientistCambridge, MA$114,100–$211,900 / yearParticipate in cross-functional early safety screening & profiling collaborations with Novartis Biomedical Research partners to support the early derisking of compounds, drug targets, and therapeutic modalitiesDeliver clear and concise presentations for audiences with different expertiseIn collaboration with cross-functional partners, provide scientific and strategic input to support the early derisking of compounds, drug targets, and therapeutic modalitiesEnsure quality and compliance of data generation, analyses and resultant reportsEssential RequirementsDegree/Advanced Degree in Pharmacology, Toxicology or a Related Field5+ years of relevant experience in pharmacology / toxicologyUnderstands the basic concepts of hazard identification and risk assessment associated with drug ADME, off-target mitigation and cardiovascular safety. Cambridge MAInternal: Principal Scientist I or IILI#-HybridThe Preclinical Safety (PCS) department within the Novartis Biomedical Research Translational Medicine Unit provides world class preclinical safety profiling and assessment for optimal drug discovery, development and commercialization, with state-of-the-art regulatory compliance.
Global Safety Officer, I&I SanofiGlobal Safety Officer, I&ICambridge, MA$178,500–$297,500 / yearReview, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling. But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
Medical Safety Physician, Pharmacovigilance Verastem IncMedical Safety Physician, PharmacovigilanceBoston, MA$230,000–$317,000 / yearMinimum 8 years of experience as pharmacovigilance physician with strong experience in handling ICSR processing for clinical trials and marketed drugs, signal detection, aggregate reports development and safety analyses from clinical trials. The Medical Safety Physician will be responsible for the medical safety activities of all pharmacovigilance activities for the assigned products including medical review of all ICSR, aggregate reports related activities and support signal detection, risk management, and submission associated activities.
Vice President, Head of Global Patient Safety & Risk Management Disc Medicine IncVice President, Head of Global Patient Safety & Risk ManagementMA$322,000–$455,000 / yearServe as patient safety and risk management SME in development of key clinical trial and regulatory submission documents (e.g IBs, protocols, Integrated Summary of Safety, Risk Management Plans (RMPs), Safety Surveillance Plans, Reference Safety Information, CCDS/PIs). Reporting to the Chief Medical Officer, you will lead and execute the safety strategy, direct all pre- and post-marketing safety operations, ensure global regulatory compliance, and work cross-functionally with key stakeholders to foster a culture of safety as we transition into a late-stage and commercial biotherapeutics organization.
Sr. Medical Director/Medical Director, Global Safety Officer Alkermes PlcSr. Medical Director/Medical Director, Global Safety OfficerWaltham, MAIn 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively in a matrixed environment, and to be able to effectively communicate with varied stakeholders.
Senior Safety Scientist Viridian Therapeutics IncSenior Safety ScientistWaltham, MAThe Senior Safety Scientist collaborates primarily with the Product Safety Lead/Safety Physician for assigned products, and also with cross-functional team members to ensure active safety surveillance of SAEs and other clinical trial safety data and lead/assist in the preparation of safety-related documents. Cross-Functional Collaboration: Work closely with clinical operations, clinical development, regulatory affairs, and other departments, including the PV vendor, to ensure the safety of clinical trial participants.
Safety Scientist Viridian Therapeutics IncSafety ScientistWaltham, MAThe Safety Scientist collaborates primarily with the Product Safety Lead/Safety Physician for assigned products, and also with cross-functional team members to ensure active safety surveillance of SAEs and other clinical trial safety data and lead/assist in the preparation of safety-related documents. Cross-Functional Collaboration: Work closely with clinical operations, clinical development, regulatory affairs, and other departments, including the PV vendor, to ensure the safety of clinical trial participants.
Director, Medical Safety Assessment Physician Bristol-Myers Squibb CoDirector, Medical Safety Assessment PhysicianMA$286,560–$347,244 / yearOversee, prepare and/or review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Director Safety Physician BioNTech SEDirector Safety PhysicianCambridge, MAOversees quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator's brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries, and other clinical/regulatory documents as needed. The MSP also ensures compliance with Good Clinical Practice (GCP) and regulatory reporting requirements, while contributing to essential safety documents such as Development Safety Update Reports (DSURs), updates to reference safety information, Investigator Brochures, and Clinical Trial Reports.
Director, Global Safety Lead Les Laboratoires Servier SASDirector, Global Safety LeadBoston, MA$250,000–$300,000 / yearSpearhead signal detection activities, including kick off activities, planning, safety data retrieval and analysis, authoring some sections of the Safety Evaluation Report (SER) or Development Safety Evaluation Report (DSER), etc. for development and marketed compounds. Responsibilities include medical review, participation in drug safety related activities associated with clinical development, signal detection and evaluation, preparation of aggregate safety reports, and contributions to benefit-risk assessments and safety risk management strategies.
Director, Patient Safety ICSR Vertex Pharmaceuticals IncDirector, Patient Safety ICSRBoston, MARemote$196,200–$294,400 / yearThis position manages the technical aspects of end-to-end safety case intake, processing, quality control, and regulatory submissions within a therapeutic area (as assigned) covering the applicable drug, biologic, medical device, and combination products, ensuring operations are consistent, compliant, and inspection-ready worldwide. The role also represents GPS in cross-functional initiatives and requires strong technical PV expertise, communication, project management, and vendor management skills.
Manager, Global Medical Safety Kiniksa Pharmaceuticals International PlcManager, Global Medical SafetyLexington, MAThis includes (but is not limited to) providing thorough sponsor oversight of delegated safety responsibilities outsourced to safety vendor, leading operations in development of aggregate reports (e.g., DSUR, PAER), providing new hire AE/SI training, and planning Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings. Working knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidance's related to pharmacovigilance (e.g., E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety.
NewSenior Product Manager - Safety Veeva Systems IncSenior Product Manager - SafetyBoston, MA$120,000–$200,000 / yearIn this role, you will work closely with customers, plus our in-house industry experts and technology A-players to iteratively define a strategic road map, design & build elegant solutions, and bring rewarding solutions to market. As the newest member of our Product Management team, you will play a crucial role in advancing Veeva Safety, an enterprise-level pharmacovigilance (drug safety) solution that manages the intake, processing, and submission of adverse events for clinical and post-market products.
Senior Scientist - Translational Safety & Risk Sciences (TSRS) Amgen IncSenior Scientist - Translational Safety & Risk Sciences (TSRS)Cambridge, MAIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Clinical Safety Specialist InterSystems CorpClinical Safety SpecialistBoston, MA$126,000–$163,000 / yearOur data platforms solve interoperability, speed, and scalability problems for large organizations around the globe to unlock the power of data and allow people to perceive data in imaginative ways. The Clinical Safety Specialist will work alongside other members of the clinical safety team to manage the adoption of InterSystems Clinical Safety Management Framework supporting the development and implementation of InterSystems products.