Jobs at Monte Rosa Therapeutics

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.

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.

Leads external corporate communications for a publicly traded biotechnology company, including press releases, investor materials, SEC disclosures, executive messaging, website and social content. Translates complex scientific and clinical information into clear narratives for investors, media, and stakeholders. Partners with Clinical, Finance, Legal, R&D, Regulatory, investor relations advisors, and public relations agencies while monitoring industry trends, investor sentiment, and media coverage.

Supports immunology and preclinical pharmacology drug discovery programs by designing experiments with primary immune cells and tissues. Performs compound profiling using MSD, ELISA, Western blot, Simple Western, flow cytometry, and qPCR; processes ex vivo mouse tissues; and maintains detailed electronic laboratory records. Requires hands-on inflammatory and immunology drug discovery experience, primary cell and tissue handling, protein detection expertise, and proficiency with Excel and GraphPad Prism.

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.