NewAssociate Director, Clinical Operations – Therapeutics/Oncology ModernaTXAssociate Director, Clinical Operations – Therapeutics/OncologyCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives.
Sr. Manager, Clinical Data Management ModernaTXSr. Manager, Clinical Data ManagementCambridge, MassachusettsRemote7 years of experience must include: Vendor Management; Medidata RAVE, InForm, and Oracle Clinical EDC tools; Clinical Data Management using Biomarker and External data; Utilizing eTMF tools; Study Database Lock processes including Final, Interim, Snapshots, DSUR submission, and Staggered Lock; Study Initiation, CSR Review, and SAE Reporting; J-Review, I-Review, and Clinbrowser; and. Lead the creation and maintenance of study cross functional data review plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, Serious Adverse Events (SAE) reconciliation guidelines, and database lock plans.
Senior Director, Global Medical Affairs, Oncology ModernaTXSenior Director, Global Medical Affairs, OncologyCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. As a key member of the global Medical Affairs team, you will be responsible for integrated evidence planning, medical governance leadership, and driving scientific thought leadership worldwide.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesBoston, MA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Global Clinical Department Strategy Expert SanofiGlobal Clinical Department Strategy ExpertWaltham, MA$178,500–$257,833.33 / yearExperience: MD with specialization in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field; or PhD in a life science area (Biology, Immunology, Pharmacology, or related field) with extensive clinical development experience. Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
Senior Director, Statistical Programming Bicycle Therapeutics PlcSenior Director, Statistical ProgrammingCambridge, MA$215,000–$270,000 / yearThe company is evaluating nuzafatide pevedotin (formerly BT5528), a Bicycle Drug Conjugate (BDC) targeting EphA2, a historically undruggable target; a pipeline of Bicycle Radioconjugates (BRCs) and imaging agents; zelenectide pevedotin (formerly BT8009), a BDC targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, the use of Bicycle technology to develop therapies to treat diseases in a range of therapeutic areas. You will ensure operational excellence across all programming activities, serve as a key strategic partner to Biostatistics and Clinical Development, and lead and mentor a team of programmers to support the successful execution of our clinical trials and regulatory submissions.
Senior Director, Program & Portfolio Management Vera Therapeutics IncSenior Director, Program & Portfolio ManagementBoston, MA$230,000–$300,000 / yearThis person will also lead the Research and Development Governance and will partner closely with the Global Program Team Lead (GPTL) and the Global Program Team (GPT) Program Manager to ensure strategic direction set by the GPT translates into clear, well-coordinated execution across Program Teams and Governance Forums. Serve as the principal execution partner to the Global Program Team Lead (GPTL) and GPT Program Manager, translating GPT-level strategy into coordinated execution plans and ensuring program risk and status are communicated clearly across governance layers.
Senior Regulatory Medical Writer Ionis Pharmaceuticals IncSenior Regulatory Medical WriterBoston, MARemote$113,000–$142,426 / yearThis role includes responsibilities throughout the lifecycle of a document including working cross-functionally to interpret source information (including leading data interpretation meetings), leading key messaging meetings, writing content following US and international regulations (including Marketing Application Module 2 summary documents), conducting quality control (QC) reviews, resolving Quality Assurance (QA) audit findings, and working with Regulatory Operations for publishing and submission. Experience writing, as lead and/or contributor, important regulatory and clinical documents such as clinical study reports (all sections including safety narratives), Investigator's Brochures, clinical study protocols, drug marketing application summary documents, Investigational New Drug applications, clinical sections of New Drug Applications, and other regulatory documents (e.g., Briefing Documents) for submission.
Clinical Research Director, Rare Diseases SanofiClinical Research Director, Rare DiseasesCambridge, MA$206,250–$343,750 / yearExperience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization. On Clinical Development, the CRD: Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes.
Global Lead, Medical Intelligence To Strategy SanofiGlobal Lead, Medical Intelligence To StrategyCambridge, MA$206,250–$297,916.66 / yearInnovation Incubation, Test & learn: Function as the primary incubator for medical intelligence innovations - scout emerging data science and AI/ML capabilities, test use cases in partnership with Digital, and define rigorous success metrics before recommending enterprise-wide scaling. The team operates at the intersection of medical science, data, and digital technology - building future-state capabilities, testing breakthrough solutions, and partnering with GBUs and Digital teams to ensure innovation creates measurable impact for patients and the business.
Principal Scientist, Systems And Disease Biology SanofiPrincipal Scientist, Systems And Disease BiologyCambridge, MA$122.25–$176.58 / hourD. in systems biology, computational biology, biostatistics, or related quantitative field with proven experience in a relevant disease area (Immunology, Neurology or Oncology) OR PhD in biological sciences, biomedical sciences, immunology, neuroscience, oncology or in a related disease area and proven advanced track record of data analytics, ML/AI, or computational biology. Leading projects involving internal experiment design and data analytics as well as outsourcing of established workflows and/or complex follow-up mechanistic assays (organoid, CRISPR, proteomics).
NewSenior Clinical Outcomes Assessment (Coa) Lead SanofiSenior Clinical Outcomes Assessment (Coa) LeadCambridge, MA$178,500–$257,833.33 / yearThis includes coaching less experienced COA scientists, acting as referral level whenever needed, leading and delivering internal educational programs, reviewing documents, representing the COA team in Sanofi asset and indication strategy meeting, as well as in FDA meetings on invitation. Example research activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs.
Senior Director, Clinical Operations Kymera TherapeuticsSenior Director, Clinical OperationsWatertown, MA$235,000–$330,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Accountable for robust operational strategies for all studies in the Phase 3 program, ensuring consistency as needed, including country and site mix, PR&R and Site Engagement strategies, vendor strategy, risk based and site monitoring strategies, etc.
Associate Director, Statistics 3316 Takeda Development Center AmericasAssociate Director, StatisticsBoston, MassachusettsCentral to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Senior/Principal Scientist Cell Based Potency Assay 3316 Takeda Development Center AmericasSenior/Principal Scientist Cell Based Potency AssayLexington, MassachusettsD. in cell biology, molecular biology, immunology, biochemistry, bioengineering, pharmaceutical sciences, statistics, biostatistics, or a related discipline with 3+ years of relevant experience for Senior Scientist or 7+ years for Principal Scientist; MS with 9+ years for Senior Scientist or 13+ years for Principal Scientist; or BS with 11+ years for Senior Scientist or 15+ years for Principal Scientist. Plan and coordinate work with departmental, cross-functional, and external stakeholders, including Process Development, Quality Control, contract testing laboratories, Analytical Sciences, Quality Assurance, Regulatory, and other Analytical Development teams.
Clinical Scientist, Neuroimmunology & Specialty Care, PDT 3316 Takeda Development Center AmericasClinical Scientist, Neuroimmunology & Specialty Care, PDTBoston, MassachusettsThis role will work within the Neuroimmunology and Specialty Care team to support development of clinical assets across the United States, the European Union, and Japan, including protocol concept and protocol development, study start-up and execution, data cleaning, preparation of clinical study reports, and contributions to regulatory filings. Proven experience preparing clinical study protocols, Clinical Study Reports, integrated clinical statistical reports, and clinical sections for regulatory submissions across multiple regions, including Investigational New Drug and New Drug Application documentation.
ClinicalData and Analytics Lead Integrated Resources, IncClinicalData and Analytics LeadCambridge, MassachusettsContractorQualifications• 5+ 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 Primary contact between Data Management and clinical study management teams (SMT and/or Clinical Development Team representatives).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).Serves as Subject Matter Expert for data, reporting, and analysis process definition, improvement, and innovation as needed.
Medical Director, Clinical Development Dyne Therapeutics IncMedical Director, Clinical DevelopmentWaltham, MA$270,000–$310,000 / yearThis role serves as the medical monitor on their assigned study(s), partnering closely with Clinical Development leadership, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics, Data Management, Translational Medicine, and other key stakeholders to support study design, protocol execution, medical review, data analysis, and regulatory deliverables. This role is responsible for ensuring participant safety, supporting high-quality study execution, interpreting emerging clinical and safety data, and providing timely medical input to study teams, investigators, vendors, and cross-functional partners.
Director, Clinical Development Wave Life Sciences LtdDirector, Clinical DevelopmentLexington, MA$255,000–$345,000 / yearThe Director, Clinical Development will collaborate closely with cross-functional partners including Clinical Operations for study design and implementation, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program Management, Preclinical Development and other functions to ensure aligned strategy and execution of all programs. This includes the design, planning, execution, scientific integrity, and medical oversight of clinical studies for all phases of development for various therapeutic areas (TA) including cardiometabolic, hepatology, and potentially additional TA programs from early clinical development through regulatory approval.
Director, Medical Affairs, Rare Disease Ipsen SADirector, Medical Affairs, Rare DiseaseCambridge, MA$225,000–$300,000 / yearThe role also includes oversight of medical information responses (in collaboration with Medical Information), scientific communications (including publications and congress presentations in partnership with the Publication team), and the design and medical oversight of US based clinical studies, as well as the review and approval of promotional and medical materials and educational grants. The Director works closely with the Medical Science Liaison team to guide field medical strategy, develop and maintain relationships with key opinion leaders, and incorporate field insights into medical planning.