Associate Director/Director, Clinical Science

Salary 180000 - 210000

Job description

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.