Associate Director/Director, Clinical Science

Responsibilities Include

• Collaborate with the Medical Director or serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy program.
• Collaborate with the Medical Director for clinical input to the clinical development plan (CDP) at all stages of the program.
• Leads (or supports) development of recommendations on further development strategies to internal committees.
• Participate in review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information.
• Participate in development, maintenance, and review of clinical study documents (e.g., protocols and protocol amendment(s), informed consent documents, case report forms) and other relevant strategic documents.
• Support activities related to the start-up and execution of new clinical trials.
• Contribute relevant clinical sections to documents such as the IB, DSUR, CSRs and regulatory documents such as INDs, CTAs, accelerated program, RMAT designations, pediatric study plans, BLAs, and MAAs.
• Be responsible for clinical data review and drafting reports and presentations on the various findings of the clinical research, including abstracts, posters, publications.
• Perform regular review of clinical data to ensure that the study is conducted in accordance with the protocol, safety procedures are followed, and efficiency is maintained.
• Assist with safety review procedures: tracking of safety events, review of new SAEs, and composing/editing adverse event narratives.
• Assist with managing vendor activities as needed.

Required Qualifications

• Bachelor of Science degree from an accredited educational institution.
• Master's degree or PhD, PharmD/RN or the equivalent degree preferred.
• Minimum 7 years of experience in clinical drug development within a pharmaceutical/biotech or academic environment.
• Strong knowledge of ICH, GCP, and other relevant regulatory guidelines.
• Solid understanding of T-cell biology and cell & gene therapy.
• Experience in writing clinical protocols and performing and summarizing relevant literature reviews.
• Strong communication and interpersonal skills.
• Engaged, hands-on, and goal-oriented mentality in a highly dynamic work environment.
• Ability to flexibly contribute simultaneously to multiple facets of drug development.
• Strong team orientation and passion for continuous self-development.