Drug Safety Assistant Integrated Resources, IncDrug Safety AssistantSomerville, MassachusettsContractorA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. • Maintain local documentation as required by legislation (including archiving/tracking/retrieval) – lifting of boxes.
NewMedical Director, Global Drug Safety Replimune Group IncMedical Director, Global Drug SafetyWoburn, MA$257,500–$333,500 / yearThe 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. Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it.
Drug Safety Associate Integrated Resources, IncDrug Safety AssociateCambridge, MassachusettsContractorThe candidate will function as an integral part of the Global Case Management team, working under the direction of a manager, to meet department objectives or assist on special projects within established deadlines. The Safety and Benefit Risk, Global Case Management department performs pharmacovigilance activities, ensuring timely adverse event reporting in compliance with applicable laws and regulations/company policies throughout the lifecycle of products.
Sr. Drug Safety Associate Integrated Resources, IncSr. Drug Safety AssociateCambridge, MassachusettsContractorSupport the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection: Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans). The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives.
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.
Drug Safety Data management Specialist Integrated Resources, IncDrug Safety Data management SpecialistSomerville, MassachusettsContractorMonitor electronic mailboxes and Argus ESM to ensure timely acceptance of Adverse Event (AE) Reports Perform data entry into databases, as needed. Ensure proper coding of events and drugs for cases to ensure correct forwarding to the relevant Therapeutic Area Teams and Licensing Group.
NewExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product 3316 Takeda Development Center AmericasExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination ProductBoston, MassachusettsAs Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.
Project Toxicologist, Director - Oncology Targeted Delivery (OTD) Safety Science, Clinical Pharmacology and Safety Sciences (Cambridge, MA or Gaithersburg, MD) AstraZeneca PlcProject Toxicologist, Director - Oncology Targeted Delivery (OTD) Safety Science, Clinical Pharmacology and Safety Sciences (Cambridge, MA or Gaithersburg, MD)Cambridge, MA$184,538–$276,808 / yearAlternative experience pathway: Candidates with a minimum bachelor's degree and substantial additional pharmaceutical industry experience may also be considered, including candidates with approximately 15 or more years of relevant experience. Professional experience: Typically, at least 10 years of experience in project toxicology, investigative toxicology, regulatory toxicology, or related safety-focused roles within the pharmaceutical, biotechnology, or CRO sector.
Senior Associate Scientist - Drug Product Development SanofiSenior Associate Scientist - Drug Product DevelopmentCambridge, MA$75–$108.33 / hourThe successful candidate will contribute to the design, development, and optimization of preclinical formulations (conventional and enabling) and clinical solid oral dosage forms (tablet and capsule), from early-stage development through scale-up and technology transfer to GMP manufacturing. Education: Bachelor's degree OR Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, Food Science, or a related life science/scientific/engineering discipline.
Associate Director, Drug Product - CMC Centessa Pharmaceuticals, LLCAssociate Director, Drug Product - CMCBoston, MA$140,000–$195,000 / yearWork closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions. Excellent communication, interpersonal, and project leadership skills, with the ability to influence stakeholders, manage cross-functional and external relationships, and effectively communicate complex concepts to diverse audiences.
Senior Director, Drug Product CMC Centessa Pharmaceuticals, LLCSenior Director, Drug Product CMCBoston, MA$165,000–$250,000 / yearReporting to the Executive Director, CMC, this position will primarily lead work with external vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions.
Associate Director, Drug Product Disc Medicine IncAssociate Director, Drug ProductMassachusetts, MA$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.
VP, Head Of Drug Discovery Relay Therapeutics, Inc.VP, Head Of Drug DiscoveryCambridge, MA$230,000–$328,000 / yearBuilt 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. This individual will be responsible for driving the discovery and optimization of transformative small molecule therapeutics by building a highly collaborative, data-driven discovery engine that combines deep scientific expertise with modern computational approaches.
Senior Director, Novel Drug Delivery Technologies Eli Lilly and CompanySenior Director, Novel Drug Delivery TechnologiesBoston, MA$166,500–$264,000 / yearOur current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL). Position Overview: The Drug Delivery group at Lilly studies physiological barriers across routes of administration to create novel, patient-centric delivery solutions, serving as a center of excellence in injection physiology, device ideation, novel drug delivery technologies across modalities and routes of administration, nanomedicine and targeted delivery, and connected devices/digital biomarkers.
Senior Director, Focused Ultrasound Drug Delivery Eli Lilly and CompanySenior Director, Focused Ultrasound Drug DeliveryBoston, MA$166,500–$264,000 / yearThis role anchors a growing technical capability in ultrasound-mediated delivery - spanning focused ultrasound (FUS) for deep-tissue and organ-specific targets as well as non-focused ultrasound approaches where spatial precision is not required for the target bioeffect - including microbubble/nanobubble-mediated bioeffects such as sonoporation and reversible barrier permeabilization, intended to enhance delivery of biologics and gene therapies across a range of deep and superficial tissue targets and emerging routes of administration. Job Position Overview: The Drug Delivery group at Lilly studies physiological barriers across routes of administration to create novel, patient-centric delivery solutions, serving as a center of excellence in injection physiology, device ideation, novel drug delivery technologies across modalities and routes of administration, nanomedicine and targeted delivery, and connected devices/digital biomarkers.
VP, Head of Drug Discovery Relay TherapeuticsVP, Head of Drug DiscoveryCambridge, MA$230,000–$328,000 / yearBuilt 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. This individual will be responsible for driving the discovery and optimization of transformative small molecule therapeutics by building a highly collaborative, data-driven discovery engine that combines deep scientific expertise with modern computational approaches.
Associate Director, Drug Product - CMC Centessa Pharmaceuticals PlcAssociate Director, Drug Product - CMCBoston, MA$140,000–$195,000 / yearWork closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions. Excellent communication, interpersonal, and project leadership skills, with the ability to influence stakeholders, manage cross-functional and external relationships, and effectively communicate complex concepts to diverse audiences.
Senior Director, Drug Product CMC Centessa Pharmaceuticals PlcSenior Director, Drug Product CMCBoston, MA$165,000–$250,000 / yearReporting to the Executive Director, CMC, this position will primarily lead work with external vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions.
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.
NewDrug Substance MSAT Scientist II Thermo Fisher ScientificDrug Substance MSAT Scientist IIPlainville, MassachusettsWe 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.