Associate Director, Clinical Scientist

Role Summary

Associate Director, Clinical Scientist for the Gene Therapy Clinical Development team. Provide clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams; support study design, execution, and regulatory documentation; collaborate with internal and external partners to advance clinical programs.

Responsibilities

• Collaborate with internal teams, CROs, and external vendors to prepare, review and finalize clinical study documents and plans
• Contribute to scientific and operational aspects and stages of protocol development and study execution from design planning through final reporting
• Provide scientific input and review of clinical study data, support medical monitoring reports, study integrity/conduct, and oversight
• Support preparation of abstracts, manuscripts, presentations, and materials for meetings related to the protocol(s) and program
• Provide protocol-level scientific review to support regulatory documents (IND submissions, IND Annual Updates, DSURs, Investigator Brochures)
• Support enrollment projections and development/implementation of subject recruitment and retention strategies
• Collaborate with team members on Data Management activities including eCRFs, edit checks, report development, and database lock processes
• Participate in data review, database lock, medical monitoring, and query resolution; provide scientific review of safety data and study plans
• Develop, review, and revise departmental and corporate SOPs and processes
• Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities

Qualifications

• Advanced degree (Pharm. D., Ph.D., M.D./MD equivalent preferred) with 3‚Äì5 years of drug development experience
• Experience with EDC systems (e.g., RAVE) and data analysis tools (e.g., J-Review)
• Strong medical writing and presentation skills
• Basic understanding of biostatistics and data management
• Ability to read and interpret scientific/technical journals, financial reports, and legal documents
• Excellent written and oral communication, time management, and organizational skills
• Ability to succeed in a fast-paced, matrix team environment; strong meeting, conflict, and cross-functional team leadership skills

Skills

• Cross-functional collaboration
• Clinical study design and execution
• Scientific analysis and interpretation
• Regulatory documentation and compliance
• Data management and safety data review

Education

• Advanced degree as listed in Qualifications

Additional Requirements

• Travel: Occasional travel required (approximately 20%)