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Oruka Therapeutics · 3 months ago

Senior Medical Director, Clinical Development

United States

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$294K/yr - $330K/yr

Oruka Therapeutics is developing novel biologics aimed at treating chronic skin diseases. The Senior Medical Director of Clinical Development will oversee clinical trials, ensuring high-quality data generation to support the safety and efficacy of pipeline products while collaborating with various stakeholders to align clinical activities with development plans.

BiotechnologyHealth CareMedical

Responsibilities

Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods

Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines

Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug

Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)

Provides medical expertise of the therapeutic area, disease state, and potential drug effects

Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team

Stays current with relevant medical literature and clinical trial methodologies

Contributes medical expertise to external interactions with collaborators throughout the clinical development cycle

Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process

Presents clinical data to internal and external stakeholders

Contributes to the overall clinical development strategy

Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding timelines

Leads the clinical contribution for clinical study reports, clinical documents and regulatory submissions

May oversee the work of Clinical Scientists working on the same or other programs

Qualification

Medical degree (MD)Clinical research experienceClinical trial designGCP guidelinesRegulatory requirementsAnalytical skillsLeadership skillsCommunication skills