Clinical Scientist, Clinical Development

Summary

Oruka Therapeutics is developing biologic treatments for chronic skin and inflammatory diseases. The Clinical Scientist, Clinical Development supports clinical trial design and execution, including protocol development, data review, clinical documentation, and assessment of safety and efficacy. The role collaborates with cross-functional teams to ensure high-quality clinical data and successful clinical development.

Responsibilities

• 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)
• 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
• 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

Skills

• 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

Qualifications

Must Haves

• 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

Benefits

• Equity
• A performance-related bonus opportunity
• Remote or Hybrid if commutable to office in Waltham, MA employee will be required to be in-office 3 days/week.
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.