Associate Director, Clinical Scientist

Responsibilities

• Contribute to the scientific development of 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
• Significantly contribute to the oversight of the clinical study in collaboration with the clinical development lead
• Present data and information to investigators and internal stakeholders, contributing to meetings with governance bodies and regulatory authorities
• 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
• Support study execution as the scientific subject matter expert
• 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
• Provide mentorship to junior clinical scientists

Requirements

Advanced scientific or clinical degree (eg MD, PhD, PharmD, DNP, MSN , etc). with 8-12+ years of relevant experience in clinical or related research

Excellent oral and written communication skills and analytical skills

Deep expertise in clinical science, with a strong track record of contributing to clinical studies

In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP)

Strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators

Qualifications

• Experience in cellular therapies/CAR-T trials
• Experience in Phase 1/Phase 2 clinical trials

Competencies

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