Clinical Scientist

Location
Seattle, WA, United States
Posted
May 03, 2021
Ref
2515362527
Required Education
Bachelors Degree
Position Type
Full time
Company Background:

Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically-engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role:

Reporting to the VP, Early Clinical Development, the Director/Senior Director of Clinical Science will be a highly visible, impactful position responsible for authoring and reviewing clinical study documents, contributing to clinical study design and rationales, obtaining expert input, presenting data to internal and external audiences and supporting clinical study conduct. As this is a newly established function, the Director/Senior Director Clinical Science will be accountable for initiating and establishing procedures and standards in collaboration with Clinical Operations.

Responsibilities:
  • Accountable to author and review clinical study-related documents
  • Clinical procedures
  • Plans and site training materials, including clinical protocols, Investigator brochure, Informed Consent forms, Case Report forms, Progress Reports
  • Regulatory briefing books and reports
  • Collaborate with Clinical Lead on study designs and rationales
  • Support interactions to obtain expert clinical advice (SAB, KOLs)
  • Support study conduct from start-up to data submission
  • Site selection and training
  • Study tracking
  • Data review
  • Presentation to internal and external audiences (eg investigator meetings, safety review committees)
  • Provide input to inform regulatory decisions
  • Writing/review of clinical content for publications and regulatory submissions
  • Collaborate with clinical operations, clinical quality, regulatory affairs, CROs, etc. to develop and review SOPs, Independent Review Charters, Procedures, Protocols, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory/safety documents


Requirements:
  • Experience in cell therapy trials and in hematology and/or oncology is highly desirable
  • Excellent verbal, written, communication and interpersonal skills
  • Detail-oriented with strong organizational skills
  • Strong ability to work collaboratively in teams
  • Critical thinking, creative problem-solving and initiative-taking skills as well as adaptability in a fast-paced environment


Preferred Qualifications:
  • Pharm D or PhD degree in life sciences
  • 12+ years of relevant industry experience


Location:
  • This role will be located in either Seattle, Washington or Philadelphia, PA and requires the ability to travel domestically and internationally (10%)


Keywords:

Regulatory Submissions, Clinical, Clinical Study Documents, Data Review, Clinical Operations, Data Review, Oncology, Life Science, Biotech, Industry, Cell Therapy

Show more Show less