Executive Director, Clinical Leader- Neuropsychiatry Johnson & JohnsonExecutive Director, Clinical Leader- NeuropsychiatryCambridge, MA$232,000–$401,350 / yearTeam leadership via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, data management, medical writing, biostatistics, global medical safety, pharmacogenomics, early clinical development, clinical pharmacology, data science, digital health, global clinical operations, health economics, epidemiology, global medical affairs and other scientific and business related disciplines. Required Skills: Preferred Skills: Clinical Research and Regulations, Clinical Trials, Collaboration, Corporate Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Health Care Regulation, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Strategic Change.
Associate Director-Medical Writer Eli Lilly and CompanyAssociate Director-Medical WriterBoston, MA$127,500–$187,000 / 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). Collaborate effectively with cross-functional teams, including clinical development, regulatory affairs, biostatistics, medical affairs, nonclinical, and legal, to gather necessary information and ensure scientific accuracy and consistency across documents.
Director, Analytical Development - Small Molecule Ardelyx, Inc.Director, Analytical Development - Small MoleculeWaltham, MA$211,000–$257,000 / yearPosition Summary: The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug product with the exception of stability program management. This position partners cross-functionally with CMC, Quality, Manufacturing, Regulatory Affairs, Supply Chain, and external partners to ensure the successful execution of analytical strategies that support reliable product supply, regulatory compliance, and business objectives.
Senior Clinical Director, Clinical Research, Hematology Merck & Co IncSenior Clinical Director, Clinical Research, HematologyBoston, MA$282,200–$444,200 / yearThe Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies.
Medical Writer (Remote, US) Getinge GroupMedical Writer (Remote, US)Boston, MARemoteStrong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, relevant MDCG guidance, ISO 14155, ICH guidance including E3 CSR, E6 (R3) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO14971). Performs comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required.
Sr.Clinical Operations Lead Integrated Resources, IncSr.Clinical Operations LeadCambridge, MassachusettsFull timeWorks closely with key scientific leaders, CRO global lead, Vendor Management, Operation Lead, study or program MDs, Program Directors, Study Management Team members including Regulatory Affairs, Medical Affairs, Commercial, Discovery, and Analytical Development. Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
Executive Director, Head of PV Operations Oversight 3316 Takeda Development Center AmericasExecutive Director, Head of PV Operations OversightBoston, Massachusetts$238,000–$374,000 / yearThis role is accountable for the operational performance of global case processing, Individual Case Safety Report (ICSR) management, regulatory reporting, tracking of market research / patient support programs (MR / PSP), performing PV review and approval of digital assets and social media programs before launch, and oversight of pharmacovigilance service providers. Oversee pharmacovigilance activities related to case intake, case processing, medical coding, triage, quality review, Individual Case Safety Reports (ICSRs), regulatory reporting, market research programs, patient support programs, and Takeda-sponsored digital assets and social media initiatives.
Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization Oruka TherapeuticsSenior Manager/Associate Director Clinical Monitoring Strategy & OptimizationWaltham, CaliforniaRemoteSupport development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans. Oruka’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.
ClinicalData and Analytics Lead Integrated Resources, IncClinicalData and Analytics LeadCambridge, MassachusettsContractor5+ years relevant work experience with a focus on data management • Deep understanding of drug development and biopharmaceutical industry required • Strong project management skills, and ability to effectively lead and collaborate with various business functions • High attention to detail including proven ability to manage multiple competing priorities • Experience overseeing outsourced clinical trials work performed by vendors • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at vendor • Deep knowledge of clinical data management with full-service global CROs and FSPs • Demonstrated ability to influence without authority • Excellent written and oral communication skill. Liaises directly with internal customers (Medical functions, Statistical Programming, Clinical Operations, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel).
Senior Director, Post Market Monitoring Job Details | Olympus Corporation Of The Americas OlympusSenior Director, Post Market Monitoring Job Details | Olympus Corporation Of The AmericasWestborough, MAThe Senior Director, Post Market Monitoring is accountable for developing and integrating advanced post market surveillance systems that combine external market intelligence, publicly available safety and regulatory data, scientific literature, real-world evidence, and internal quality data sources to generate actionable insights that improve product performance, patient safety, and regulatory compliance. The Senior Director will lead the implementation of AI-enabled analytics and signal detection capabilities that transform structured and unstructured data into meaningful risk intelligence, enabling the organization to identify trends, emerging risks, and new use cases before they escalate into significant quality, regulatory, or business risks.
Clinical Safety Data Manager Integrated Resources, IncClinical Safety Data ManagerCambridge, MassachusettsFull timeSupport 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.
NewClinical Development Associate Medical Director-Nephrology Vertex PharmaceuticalsClinical Development Associate Medical Director-NephrologyBoston, Massachusetts$204,000–$306,000 / yearParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports.
Research Compliance Specialist Tufts UniversityResearch Compliance SpecialistBoston, MassachusettsThis position is part of the Research Compliance team and partners closely with faculty, researchers, administrators, and institutional stakeholders to support Research Security, Export Controls, Conflict of Interest (COI), and other research compliance initiatives that help advance, protect, and safeguard the university's research enterprise. We are seeking a highly organized and collaborative professional who can independently manage competing priorities, communicate effectively with faculty and researchers, and help support the continued growth of the university's Research Security, Export Controls, Conflict of Interest, and research compliance programs.
NewAssociate Director, Global Labeling Lead 3316 Takeda Development Center AmericasAssociate Director, Global Labeling LeadMassachusettsThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is: Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device. In close collaboration with the Takeda R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.
NewMedical Director, Gastrointestinal & Inflammation (Remote) 3316 Takeda Development Center AmericasMedical Director, Gastrointestinal & Inflammation (Remote)MassachusettsRemoteProvide patient safety input to the clinical development program for assigned products and development compounds, and represent GPSE on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable. Principal responsibilities include: Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product.
Manager, Quality Control Consultant The Steely GroupManager, Quality Control ConsultantHybrid, Waltham, MAThe selected candidate will work collaboratively with Analytical Quality Control leaders to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs and Quality Assurance to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities. Contribute to regulatory and technical documentation by reviewing QC data for accuracy, completeness, and traceability; verifying data transcription and data checks supporting regulatory submissions; and ensuring information is ready for inclusion in internal reports, APQRs, Module 3 submission-supporting documents, and responses to regulatory authorities.
Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT Vertex PharmaceuticalsAssociate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGTBoston, Massachusetts$156,600–$234,800 / yearThe Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes.
Associate Director, Manufacturing Process And Technical Quality Assurance Cell And Genetic Therapies - Vcgt Vertex Pharmaceuticals, IncAssociate Director, Manufacturing Process And Technical Quality Assurance Cell And Genetic Therapies - VcgtBoston, MA$156,600–$234,800 / yearGeneral Summary: The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes.
NewAssociate Director - Value, Access, Insights, and Solutions 3310 Takeda Pharmaceuticals U.Associate Director - Value, Access, Insights, and SolutionsLexington, MassachusettsDevelops and maintains a broad network of mutually supportive relationships with internal Takeda colleagues (Medical Product Teams, Medical Communications, VEG, Marketing, Managed Markets, Market Access Channel Strategy, Government External Affairs, Account Management and other affiliates) to ensure US Medical scientific and outcomes research and external affairs strategies are integrated across groups. The Associate Director of Value Access Insights & Solutions is an integral member of the Marketing Content Enablement & Customer Engagement group and is responsible for: Serving as a partner to Product Medical Units, Medical Communications, Medical leads, Field Medical Leaders, Brand Teams, Market Access and Channel Strategy, Public Affairs and other Global and US internal stakeholders to ensure strategic alignment on cross-functional imperatives and initiatives.
Associate Product Development Scientist Ajinomoto Cambrooke, Inc.Associate Product Development ScientistAyer, MassachusettsFull timeWorking Conditions / Physical Requirements: WORKING CONDITIONS: This position works in a food manufacturing environment and requires the ability to adhere to all GMP, Food Safety, workplace safety and security policies including wearing required personal protective equipment, as well hair net, beard net, etc. Strong collaboration with product development, regulatory affairs, quality, operations, and commercial team members to ensure development and commercialization of medical nutrition products of highest quality and sensory attributes that meet the needs of the patient population.