Medical Director, Clinical Development

Oruka Therapeutics Inc; Waltham (MA); On-site; USD 256,000 - 288,000; Full time

Benefits offered by this job

Equity

Bonus opportunity

Professional growth

Job summary

Oruka Therapeutics Inc., Nasdaq: ORKA, seeks a Medical Director of Clinical Development. This remote or hybrid role oversees trial design, study execution, and data interpretation to ensure high‑quality safety and efficacy data across programs.

Lead medical strategy, collaborate across clinical operations, regulatory, biometrics and PM teams, and contribute to study reports and regulatory submissions. MD with board certification and strong R&D track record required; offers competitive salary,

Qualifications

• MD with board certification in a relevant specialty.
• Extensive experience in clinical research and development in the pharmaceutical industry.
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements.
• Excellent communication, leadership, and analytical skills.

Responsibilities

• Oversee clinical trial design and conduct at sites in compliance with protocols and GCP.
• Provide medical expertise and review safety data.
• Collaborate with cross-functional teams to optimize development processes.
• Lead or contribute to regulatory submissions and study reports.

Skills

Clinical trial design

GCP guidelines

Regulatory knowledge

Leadership

Communication

Education

Medical degree

Job description

Remote; Waltham, Massachusetts, United States

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. For more information, visit www.orukatx.com

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: Medical Director, Clinical Development

Location: Remote OR Hybrid 3 days/week if located near office in Waltham, MA will be required.

Role Overview:

Medical Director of Clinical Development plays a key role in the execution and operational oversight of clinical trials, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves supporting clinical study design, implementation, and data interpretation while working cross-functionally to align clinical activities with overall development plans. The Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives.

Key Responsibilities:

• Clinical Trial Design and Oversight:
  • 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)
• Medical Expertise:
  • 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
• Cross-Functional Collaboration:
  • 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
• Strategic Leadership:
• 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

Qualifications:

• Medical degree (MD) with board certification in a relevant specialty
• Extensive experience in clinical research and development, ideally within the pharmaceutical industry
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements
• Excellent communication, leadership, and analytical skills

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for the Medical Director is $256,00-288,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Salary Range for the Role

$256,000 - $288,000 USD

What We Offer:

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

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.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.