Clinical Scientist/ Senior Clinical Scientist

Role Summary

Reporting to the Director of Clinical Development, the Clinical Scientist/Senior Clinical Scientist will provide scientific input to early and later stage clinical development programs.

Responsibilities

• Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs)
• Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations
• Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
• Assist in communicating a clear overview of trial results
• Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
• Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions
• Review and synthesize scientific literature and competitive intelligence to support study and program strategy
• Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
• Support preparation of scientific material for conference presentations or publications
• Contribute to the authoring and revision of regulatory submissions
• Perform analyses and generate scientific slide decks based on clinical, translational and other datasets

Qualifications

• Required: Advanced scientific or clinical degree (e.g., PhD, PharmD, MPH, etc).
• Required: Clinical Scientist: 1-3 years / Senior Clinical Scientist: 4-8+ years of previous experience in clinical or related research
• Required: Excellent oral and written communication skills and analytical skills
• Required: Ability to work collaboratively in a fast-paced, team-based matrix environment
• Required: Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
• Preferred: Experience in cellular therapies/CAR-T trials
• Preferred: Experience in Phase 1/Phase 2 clinical trials

Skills

• Collaborative ‚Äì Openness, one team, positivity
• Undaunted ‚Äì Fearless, can-do attitude, self-starter
• Results Orientation ‚Äì Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical
• Entrepreneurial Spirit ‚Äì Proactive; Ownership mindset; Thinks outside the box