Jobs at Oruka Therapeutics

Provides statistical leadership for Phase I–IV clinical development programs. Leads study design, protocol development, statistical analysis plans, clinical study reports, regulatory submissions, and interpretation of trial results. Oversees biostatistical timelines, CROs, data management and programming deliverables, and statistical programming. Partners with Clinical and Regulatory teams while ensuring compliance with FDA, EMA, ICH-GCP, CDISC, and company standards.

Leads biostatistical execution for Phase I–IV clinical trials, including study design, statistical analysis plans, protocol development, reporting, and interpretation of results. Authors and reviews clinical documents, develops statistical programs, oversees CRO biostatistics vendors, and ensures compliance with SOPs, ICH-GCP, FDA/EMA regulations, and CDISC standards. Collaborates cross-functionally while managing timelines, deliverables, risks, and ad hoc analyses in a fast-paced biotech environment.

Leads technical development and program execution for pharmaceutical combination device platforms, including autoinjectors and prefilled syringes. Responsibilities include design controls, risk management, verification and validation, human factors support, supplier and CDMO oversight, technology transfer, manufacturing campaigns, investigations, CAPAs, regulatory submission support, and cross-functional project management. The role requires hands-on device engineering expertise, external partner management, and approximately 20–30% international and domestic travel.

Collects and evaluates adverse event data, supports safety signal detection, risk assessments, case processing, data reconciliation, and pharmacovigilance documentation. Contributes to DSURs, risk management plans, regulatory submissions, literature reviews, and global drug safety compliance. Collaborates with clinical, regulatory, medical affairs, data management, and project management teams while supporting vendor oversight and safety activity coordination.

Leads statistical programming across clinical trials, overseeing SAS development and validation of tables, listings, figures, and analysis datasets. Coordinates internal teams and CRO vendors, ensures audit and regulatory submission readiness, and collaborates with biostatistics, data management, and clinical development teams on CDISC specifications and timelines. Represents statistical programming in audits and health authority meetings while developing tools, maintaining compliance, and providing technical leadership.

Coordinate biosample operations across clinical trials, including collection, shipment, reconciliation, chain-of-custody documentation, laboratory transfers, vendor oversight, and data quality review. Support study startup, audit readiness, issue resolution, reporting, and process improvement while collaborating with clinical operations, laboratories, vendors, and cross-functional biotech teams.

Supports Clinical Pharmacology and Nonclinical development programs by managing project timelines, deliverables, meetings, reviews, vendors, budgets, contracts, and operational tools. The role coordinates cross-functional activities, tracks risks and action items, facilitates document approvals, and improves project management processes. Candidates should have scientific or technical training, pharmaceutical or biotech experience, strong communication skills, and proficiency with project management tools.

Support CMC program execution by coordinating late-stage manufacturing, process development, analytical, quality, and regulatory readiness activities. Manage CMC documentation workflows, trackers, meeting materials, risk and issue logs, and CDMO communications. Maintain timelines, track deliverables, escalate issues, and contribute to continuous improvement of project management tools and processes.