Jobs at Rhythm Pharmaceuticals

Lead end-to-end development and lifecycle management of drug-device combination products (prefilled syringes, auto-injectors). Own DHF and design controls, drive verification/validation, human factors, risk management, regulatory support, and manufacturing tech transfer. Manage cross-functional teams and external vendors/CDMOs to deliver patient-centric, compliant devices from late-stage development through commercialization.

The Director of Nonclinical Development leads and executes nonclinical strategies, manages CRO relationships, and contributes to regulatory submissions for clinical programs.

Develop, validate, and QC analysis datasets, tables, listings, and figures for clinical studies and regulatory submissions. Create ADaM specs, TLF shells, reusable macros, and submission-ready documentation (define.xml, reviewer guides). Partner with Biostatistics, Data Management, Clinical Development, and vendors; identify risks, drive process improvements, and mentor junior programmers as needed.

Provide strategic and technical leadership for analytical development and QC across the product lifecycle. Define control strategies, lead method development/validation/transfer, oversee stability and impurity programs, ensure cGMP/data integrity compliance, manage CDMO/CRO partnerships, support regulatory CMC submissions and inspections, and build a high-performing analytical organization.

The Treasury Manager oversees cash operations, banking administration, compliance, financial analysis, and partnerships to optimize liquidity and streamline treasury functions.

The Head of Global Strategic Sourcing leads the strategic sourcing function, manages supplier relationships, and ensures alignment with business objectives. Responsibilities include executing sourcing vision, optimizing costs, building supplier partnerships, and establishing governance frameworks.

Manage U.S. multi-state payrolls for 270+ employees and Canadian payroll. Ensure compliance with tax laws and improve payroll processes.

Provide legal support for global clinical operations including drafting, reviewing, and negotiating clinical trial contracts (CROs, sites, vendors), lead CLM processes and playbooks, advise business leaders on risk-based strategies, manage outside counsel, and contribute to cross-functional life sciences legal matters.

Lead design, execution, and interpretation of mechanistic and translational in vitro and in vivo studies via CROs and collaborators to inform discovery and early-stage development. Identify and prioritize exploratory biology initiatives, develop hypotheses and assays, integrate multidisciplinary data, guide program strategy, and communicate findings to senior leadership while managing external partners and cross-functional teams.

Lead GCP/GLP/GVP quality oversight for clinical studies, manage QMS and vendor audit programs, develop SOPs and training, support regulatory inspections, review clinical and safety documents, identify and mitigate compliance risks, and partner cross-functionally to ensure GCP compliance and quality across programs.

Lead data management for multiple clinical studies and/or a development program. Oversee CRO-managed data activities, ensure timelines and data quality, develop DM metrics and SOPs, support vendor qualification and audits, drive inspection readiness and submissions, mentor staff, and contribute to operational improvements and hands-on data management as needed.

Lead development and deployment of AI-driven phenotyping pipelines using EMR and real-world data to define cohorts, extract features, and validate phenotypes. Integrate clinical, genomics, and biomarker datasets, build reproducible SQL/Python/R pipelines, apply statistical genetics and rare variant analyses, and improve data infrastructure to support Genetics-led programs.

Lead and oversee pharmacovigilance operations across clinical and post-marketing products, manage safety case processing and PV vendors, contribute to global aggregate safety reports (PBRER/PSUR/DSUR), provide PV input to clinical and regulatory documents, support audits and process improvements, and mentor junior staff to ensure regulatory compliance and high-quality safety data.