Clinical Scientist

 Position Summary:

We are seeking a highly motivated and experienced Clinical Scientist to join our clinical development team, focusing on the design, execution, and oversight of late stage clinical trials. The Clinical Scientist will play a critical role in advancing our clinical programs, ensuring the generation of high-quality data, and contributing to the successful submission of regulatory dossiers.

Responsibilities:

• Clinical Trial Design and Planning:
  • Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous late stage clinical trials.
  • Contribute to the development of study protocols, investigator brochures, informed consent forms, and other essential study documents.
  • Provide scientific input for trial endpoints, patient populations, and statistical analyses.
• Study Execution and Oversight:
  • Act as the scientific lead for assigned late stage studies, ensuring adherence to clinical trial protocols and regulatory requirements.
  • Provide ongoing scientific and clinical input during trial execution, including participation in investigator meetings, site initiation visits, study monitoring activities, and medical data review.
  • Review and interpret clinical trial data, ensuring consistency and alignment with study objectives.
  • Address protocol-related questions from investigators and site staff.
• Regulatory and Compliance:
  • Contribute to the preparation of regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings.
  • Ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory standards.
• Data Analysis and Reporting:
  • Collaborate with the Biostatistics and Data Management teams to review and interpret study data, ensuring accuracy and completeness.
  • Participate in the preparation of abstracts, presentations, clinical study reports, and manuscripts for scientific meetings and publications.
• Cross-Functional Collaboration:
  • Partner with cross functional team members to develop and execute clinical development strategies.
  • Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making.

 Qualifications:

•  BA/BS required with 10+ years of relevant experience
• Advanced degree in a scientific discipline (PhD, PharmD, MD, or equivalent) preferred.
• Late-stage development/registrational study experience, and specifically filing experience i.e. BLA or NDA
• Comprehensive understanding of drug development processes and GCP guidelines.
• Proven ability to interpret and synthesize clinical and scientific data.
• Strong written and verbal communication skills, with experience preparing regulatory documents and scientific publications.
• Ability to work collaboratively in a fast-paced, team-oriented environment.
• Detail-oriented with strong organizational and project management skills.

Preferred Qualifications:

• Experience in a specific therapeutic area (e.g., oncology, cardiology, endocrinology, or rare diseases) relevant to the company’s pipeline.
• Familiarity with regulatory requirements for global clinical trials, including FDA and EMA guidelines.
• Proficiency in using clinical trial management systems and other relevant software.