Job Title: Clinical Scientist, Clinical Development

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office in 3 days/week. Remote considered.

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

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 candidates, who will work in Waltham, MA (remote may be considered) is $140,000 to $155,000. 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.