Executive Medical Director, Clinical Development

Executive Medical Director, Clinical Development

Menlo Park, California, United States;
Remote;
Waltham, Massachusetts, United States

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics to set a new standard for the treatment of chronic skin diseases, focusing on plaque psoriasis. The mission is to provide patients with high rates of complete disease clearance with infrequent dosing. We advance a proprietary portfolio of best‑in‑class antibodies targeting core mechanisms underlying plaque psoriasis and related dermatologic and inflammatory diseases.

Job Title: Executive Medical Director, Clinical Development

Location: Remote or hybrid 3 days/week if located near our offices in Waltham, MA or Menlo Park, CA.

Role Overview: The Executive Medical Director leads the design, execution, and oversight of clinical trials at the asset level, ensuring high‑quality data to support safety and efficacy of our pipeline. The role includes building a team, influencing strategy, and coordinating cross‑functionally to align clinical activities with development plans.

• Strategic Leadership:
• Drive the clinical development strategy for one or more assets.
• Identify critical milestones and ensure team alignment toward timelines.
• Lead the clinical team’s contribution to study reports, key clinical documents, and regulatory submissions.
• Directly manage and/or mentor Medical Directors, Clinical Scientists, and other team members.
• Clinical Trial Design and Oversight:
• Lead development of trial protocols, patient selection, endpoints, and data collection methods.
• Oversee trial conduct, ensuring adherence to protocols and GCP guidelines, working with CROs and external partners.
• Review and interpret clinical data to assess safety and efficacy, driving timely decisions.
• Manage clinical contributions to regulatory documents such as Protocols, Investigator Brochures, and CDRs.
• Medical Expertise:
• Provide deep medical and scientific expertise in the therapeutic area.
• Analyze safety concerns and collaborate with pharmacovigilance on benefit‑risk assessment.
• Keep current with literature and trial methodologies.
• Contribute medical expertise to KOL engagement, advisory boards, and regulatory interactions.
• Cross‑Functional
  
  Collaboration:
  
  
• Work with operations, regulatory, medical affairs, biometrics, pharmacovigilance, pre‑clinical, and project teams.
• Present clinical data to internal and external stakeholders.
• Lead, coach, mentor, and manage performance of a high‑impact team.
• Foster accountability, collaboration, and scientific rigor.
• Support hiring and resource planning.

• Medical degree (MD) with board certification in a relevant specialty.
• Extensive experience in clinical research and development within the pharmaceutical industry.
• Proven people‑leadership experience managing direct reports.
• Strong understanding of trial design, GCP, and regulatory requirements, ideally with Phase 2/3 study experience.
• Excellent communication, leadership, and analytical skills.
• Track record of influencing strategy while driving hands‑on execution.
• Experience in a small or emerging biotech environment, operating in a fast‑paced setting.

• Competitive base salary and equity, with a performance‑related bonus opportunity.
• Anticipated salary range: $331,000 – $368,000 USD.

• Chance to impact medicine development in a vibrant startup culture.
• Competitive salary and benefits package.
• Inclusive team environment encouraging authentic participation.
• Opportunities for professional growth and development.

As set forth in Oruka Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.