Description
Company Background:
Century Therapeutics is an innovative biotechnology company building an industry-leading allogeneic iPSC-derived cell therapy platform. This platform integrates cutting-edge gene editing, protein engineering, technical development, and manufacturing capabilities to generate allogeneic, iPSC-derived NK and T cell therapies for cancer, autoimmune, and inflammatory diseases.
Century's foundational technology is built on induced pluripotent stem cells (iPSCs), which have an 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 cell products for the treatment of cancer and autoimmune and inflammatory diseases with significant unmet medical needs.
*Role:*
* Collaboration with the clinical team on the type 1 diabetes (T1D) beta-islet transplantation program.
* External and internal communication on the T1D program.
* Endocrinology/T1D expertise for preclinical and early phase pipeline products.
* Clinical oversight and/or medical monitor of the CNTY-813 clinical trial and other trials as needed.
* This role is remote anywhere in the United States but does require the ability to travel for site visits, conferences, and to Century's offices in Philadelphia/Boston/Branchburg, NJ for meetings as required.
Requirements
Clinical Development:
* Deliver the clinical development plan for CNTY-813 – Century's beta islet cell product - in collaboration with translational, regulatory, research, CMC, and other experts.
* Prepare, present, and manage materials for external advisory boards to guide protocol and product development.
* Interact seamlessly with biomarker translational scientists to inform and refine clinical product development and strategy.
* Support the regulatory development plan for CNTY-813 including both strategy and clinical input for regulatory interactions Clinical Trial Oversight:
* Provide medical guidance to investigators managing patients on clinical protocols.
* Serve as the medical monitor for T1D program(s).
* Oversee and assess clinical data and safety narratives.
* Provide medical and scientific expertise to study teams and key stakeholders.
* Contribute to clinical sections of INDs, Investigator Brochures, CSRs, and clinical expert reports.
Other Responsibilities:
* Serve as the medical endocrinology expert for Century Therapeutics.
* Cultivate and nurture strong collaborations, relationships and support with Investigators, academic partners and KOLs.
* Represent the team with internal and external leaders by leveraging knowledge of pharmaceutical development and business environment to convey Century's opportunity for impact in this therapeutic area.
* Work with cross-functional team members to prepare abstracts, manuscripts, and presentations for external meetings.
*Qualifications:*
* Physician (MD a prerequisite) or physician/scientist (PhD in relevant field is desirable) with >5 years industry and clinical experience.
* Completion of fellowship in Endocrinology with Board certification or similar level of experience is desirable.
*Requirements:*
* Strong track record in type 1 diabetes clinical trials, experience in early phase trials.
* Experience in pivotal phase or registration trials preferred
* Experience establishing and working with data monitoring committees, safety review committees, and independent response adjudication committees.
* Excellent verbal, written, communication and interpersonal skills.
* Driven by scientific curiosity with track record of independent clinical, laboratory or translational research in the academic and/or industry setting.
* Strong team player able to effectively communicate and collaborate across functions and job levels.
* Willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
* Routinely takes initiative, makes strategic decisions, and is highly engaged and accountable for all parts of assigned projects.
* Detail-oriented with expertise in hypothesis testing methods, statistical design, and data interpretation.
* Ability to travel for site visits, conferences, and to Century's offices in Philadelphia/Boston/Branchburg, NJ for meetings as required.
Century Therapeutics Inc. is an Equal Employment Opportunity/Affirmative Action Employer - Minority/Female/Disability/Veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status or any other characteristic protected by federal, state, or local law.