Director, Clinical Scientist

Role Summary

Director, Clinical Scientist for the Gene Therapy Clinical Development team to help expand what’s possible for patients with serious diseases. Provides clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, and supports overall program adherence to SOPs.

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 of protocol development and study execution from design to final reporting
• Provide scientific input and review of clinical study data, support medical monitoring reports, study integrity/conduct, and study oversight
• Support preparation of abstracts, manuscripts, presentations, and materials related to the protocol and program
• Provide protocol-level scientific review for regulatory documents (IND submissions, IND Annual Updates, DSUR, Investigator Brochures)
• Support enrollment projections and develop/implement subject recruitment and retention strategies

Qualifications

• Advanced degree (Pharm. D., Ph.D., M.D./ MD equivalent preferred) with minimum 5 years of drug development experience
• Experience with EDC systems (e.g., RAVE) and data analysis tools (e.g., J-Review) required
• Strong medical writing and presentation skills
• Basic understanding of biostatistics and data management
• Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents
• Excellent written and oral communication skills, time management and organizational skills
• Ability to succeed in a fast-paced, matrix team environment

Skills

• Clinical study design and execution
• Data management and safety data review
• Regulatory documentation and submissions
• Scientific writing and presentation
• Cross-functional collaboration

Education

• Advanced degree as noted in Qualifications

Additional Requirements

• Travel: Some travel may be expected