Jobs at Monte Rosa Therapeutics

Designs and leads preclinical in vivo pharmacology studies in mouse models of immunology, inflammation, and oncology. Performs animal procedures, pharmacokinetic/pharmacodynamic studies, immune profiling, flow cytometry, tissue processing, and ex vivo assays. Interprets and presents findings, troubleshoots experiments, coordinates cross-functional study execution, mentors junior scientists, and supports animal facility operations, protocols, and standard operating procedures.

Develops and executes cellular assays supporting drug discovery, compound profiling, and mechanism-of-action studies. Responsibilities include mammalian cell culture, CRISPR/Cas9 engineering, engineered cell-line characterization, molecular biology, protein analysis, functional cellular readouts, assay optimization, automation, quantitative data analysis, and workflow scale-up. The contractor collaborates with internal teams and CROs, maintains experimental records and materials, troubleshoots independently, and follows laboratory safety and quality procedures.

Supports and administers clinical operations systems including EDC, IRT/RTSM, eTMF, and CTMS. Builds and maintains AWS-based data pipelines and integrations for clinical, operational, biomarker, and assay data. Automates manual processes, monitors pipeline health, supports audit readiness and data integrity, and partners with Clinical Operations, Clinical Data Science, Biomarkers, CROs, vendors, and IT teams.

Develops global CMC regulatory strategies and authors CTD Module 3, Module 2.3, IMPD, and health authority responses for small-molecule drug programs. Coordinates cross-functional input across chemistry, analytical development, drug product, quality, clinical supply, and external manufacturing partners. Leads regulatory risk assessments, supports FDA and EMA interactions, interprets evolving ICH and global requirements, and helps establish CMC regulatory processes and best practices.

Provides hands-on IT support across Windows, macOS, mobile devices, SaaS applications, conference-room technology, and basic networking. Serves as a help desk escalation point, manages device administration and patching, maintains documentation, and develops automations, API integrations, and AI-enabled workflows to improve productivity for scientific and administrative teams.

Leads global Phase I–III clinical trial planning, execution, budgets, timelines, vendor oversight, and quality compliance across oncology and non-oncology indications. Develops operational strategies, manages CROs and cross-functional study teams, contributes to regulatory and clinical documents, tracks study metrics, mentors team members, and supports process improvement. The role requires a hybrid Boston schedule with approximately 30–40% travel for site visits, investigator meetings, and international activities.

Leads global clinical operations strategy and execution for oncology and autoimmune/inflammatory disease trials from first-in-human through Phase III. Oversees study timelines, budgets, quality, CROs, vendors, data review, regulatory documentation, risk mitigation, and cross-functional teams. Manages clinical operations personnel and external partners while ensuring compliance with FDA regulations, ICH/GCP, internal SOPs, and local requirements. The role requires substantial investigator and site engagement, approximately 30–40% travel, and a hybrid schedule with 70% Boston office presence.

Supports Phase I–III clinical trials through site monitoring, study startup, data oversight, regulatory documentation, and CRO/vendor oversight. Responsibilities include monitoring visits, SDV, SDR, query management, CAPA resolution, TMF maintenance, IRB/IEC submissions, site activation, investigator training, and clinical trial system management. The role focuses on Oncology or I&I indications and requires approximately 30–40% travel with 70% office presence in Boston.

Supports clinical trial planning, startup, maintenance, and closeout. Responsibilities include preparing study documents, coordinating with investigators and sites, reviewing regulatory packets and monitoring reports, tracking clinical data, biological samples, investigational medicinal products, and trial master files, supporting vendor finance processes, and maintaining inspection readiness. The role also contributes to SOP development, process improvements, and cross-functional trial communications.

Provides strategic GCP and GCLP quality oversight for preclinical and clinical programs. Responsibilities include vendor and investigator site oversight, SOP authorship, risk-based compliance programs, CAPA and quality event management, training, audits, regulatory submission review, inspection readiness, and cross-functional collaboration. Requires extensive pharmaceutical or biopharmaceutical experience, knowledge of global GCP regulations, and leadership in matrixed startup environments.

Coordinates regulatory workflows and prepares FDA and international regulatory submissions, license renewals, and annual registrations. Reviews and formats clinical, CMC, and non-clinical documentation; tracks timelines and budgets; researches regulatory requirements; supports product registration; and interacts with regulatory agencies. Requires extensive small-molecule CMC expertise, FDA filing experience, and strong project management, analytical, organizational, and communication skills.

Manage compound storage, retrieval, distribution, solution preparation, and automated plate production for screening teams. Track compound transfers using software, maintain laboratory equipment and safety standards, and support small-molecule degrader discovery. Requires hands-on sample management experience, LIMS and laboratory automation knowledge, strong documentation accuracy, organizational skills, and effective collaboration in a chemistry laboratory environment.

Leads immunology and inflammation drug development programs from mid- to late-stage development through regulatory submission. Responsibilities include integrated planning, scenario modeling, risk mitigation, regulatory coordination, budget and resource oversight, executive communication, and cross-functional leadership across clinical, CMC, manufacturing, regulatory, biomarker, translational, and commercial teams.

Leads global regulatory strategy for pharmaceutical development programs from early development through approval and lifecycle management. Oversees INDs, CTAs, marketing applications, designations, regulatory submissions, and health authority interactions with agencies including FDA, EMA, and PMDA. Provides strategic guidance to cross-functional teams, manages regulatory vendors and consultants, maintains regulatory files and commitments, and develops controlled processes and documents.

Leads and executes biostatistical strategy for Phase 1–3 oncology and inflammation clinical trials. Responsibilities include trial design, endpoint selection, sample size justification, interim analyses, SAPs, TLFs, CSRs, regulatory submissions, and oversight of outsourced CRO statistical and programming work. Directs production and validation of CDISC-compliant SDTM and ADaM datasets, mentors programmers, ensures regulatory compliance, and collaborates with clinical, data management, and regulatory teams.

Leads HR operations, HRIS administration, compliance, employee lifecycle processes, workforce reporting, benefits, vendor management, and annual HR programs. Partners with Payroll, Finance, Talent Acquisition, and cross-functional stakeholders to improve policies, workflows, automation, and employee services while maintaining accurate and confidential employee records.

Oversee end-to-end clinical data management for clinical studies, including CRO and vendor management, CRF and database development, data cleaning, reconciliation, coding, query management, database lock, and inspection readiness. Collaborate cross-functionally with clinical, biostatistics, medical, safety, regulatory, and technology teams. Support oncology and biomarker-driven trials, clinical data standards, GCP compliance, vendor oversight, process development, and preparation of clinical data outputs.

Provide hands-on IT support across Windows, macOS, mobile devices, SaaS applications, conference room technology, and networks. Escalate help desk issues, manage endpoint compliance and patching, maintain documentation, and support hybrid collaboration. Develop lightweight automations, API integrations, AI copilots, and agentic workflows to reduce manual effort and improve productivity for scientific and administrative teams.