Executive Medical Director, Clinical Development

About Us

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title

Executive Medical Director, Clinical Development

Location

Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview

The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans. The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment. The role reports to the Vice President of Clinical Development.

Key Responsibilities

• Strategic Leadership:
  • Drives the clinical development strategy for one or more assets
  • Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
  • Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
  • Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
• Clinical Trial Design and Oversight:
  • Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
  • Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
  • Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
  • Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
  • Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects
  • Reviews clinical data to identify and analyze safety concerns and adverse events, working with cross-functional teams to manage risk