Clinical Scientist, 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. 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:

Clinical Scientist, Clinical Development (Multiple openings)

Location:

Remote or Hybrid if commutable to office in Waltham, MA employee will be required to be in-office 3 days/week.

Role Overview:

The Clinical Scientist plays a key role in the execution and operational support of clinical trials, assisting in the collection and review of clinical data to ensure study success. This role involves supporting protocol development, study implementation, data review, and documentation preparation to align with clinical development goals. The Clinical Scientist collaborates closely with cross-functional teams to ensure the generation of high-quality clinical data.

Additionally, they work closely with the Medical Director, Clinical Development to execute key tasks.

Key Responsibilities:

• Clinical Trial Design and Oversight: Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
• Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
• Perform data review, reconciliation and standardization to ensure high quality outputs
• Reviews clinical data to support in the assessment of the safety and efficacy of the investigational drug.
• Supports the development of clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports).
• Scientific Expertise: Maintains knowledge of the therapeutic area, disease state, and potential drug effects.
• Assesses clinical data to help identify and analyze safety concerns and adverse events Stays current with relevant medical literature and clinical trial methodologies.
• Conducts literature reviews as needed for focused scientific questions or documentation.
• Cross-Functional Collaboration: Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to ensure data integrity during the clinical development process.

Qualifications:

• Advanced degree in life sciences, such as a PhD, PharmD or related field
• Understanding of clinical trial methodologies and regulatory requirements
• Experience in clinical study design, data analysis, data review and interpretation
• Good written and verbal communication skills
• Ability to work effectively in a collaborative, cross-functional environment
• 3 years experience

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.