About Century Therapeutics Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care.
Description Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care.
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.
* Candidates located around our sites in Philadelphia/Boston/Branchburg, NJ are preferred but remote candidates in the United States will also be considered.
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 or DO 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.
#J-18808-Ljbffr