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 COO, the candidate will be responsible for leading a Regulatory Affairs group, defining and implementing the global development and technical regulatory strategies for Century's iPSC derived, genome edited, allogenic cell therapies for hematology and oncology. The incumbent will lead interactions with health authorities, partners, and CROs on behalf of Century to enable our expanding pipeline. The candidate will also oversee Clinical Compliance, and serve on company governance committees including the compliance committee.Responsibilities
1) Strategic and operational leadership of Regulatory Affairs for Century including:
- Establish stage-appropriate regulatory affairs group, staff and capabilities
- Manage existing Regulatory Affairs team (Heads of Regulatory CMC and Regulatory Strategy and Operations) and external resources
- Expand capabilities, define, manage, and coordinate regulatory workflow and budget for internal group and collaborators, consultants, and vendors
2) Define global hematology and oncology and technical regulatory strategies and plans for allogeneic products, taking into account product safety, efficacy, and quality.
- Lead execution of strategy, applying expert therapy knowledge of global cell and gene therapy guidance
- Define timing and content of health authority interactions.
- Define and execute regulatory strategies for combination product and companion diagnostic development
3) Lead health authority interactions, negotiations, and filings on behalf of Century
- With team, identify regulatory risk areas and develop alternate courses of action
- Plan, manage, prepare, and review regulatory submissions. Accountable for ensuring that regulatory submissions meet standards, quality, and guidance
- Foster and maintain relationships with global regulatory authorities and external regulatory professionals on behalf of Century
4) Lead definition and execution of the Clinical Compliance area with external and internal resources
- Ensure GCP compliance for clinical programs, all areas, in line with ICH and global health authority regulations
- Oversee stage-appropriate SOP and policy establishment, clinical service provider selection, quality assurance and risk assessments related to clinical studies and services.
5) Serve on Century decision making and compliance governance committees
- Serve as an expert for regulatory precedent and emerging trends for cell therapy and hematology and oncology products
- Provide input into internal programs and conduct BD evaluations
6) Provide regulatory intelligence and take part in activities influencing evolving policy
7) Collaborate closely with all areas within CenturyTechnical Skills and Qualifications
- PhD in a scientific field (for example, molecular biology or immunology) or PharmD preferred, with >10 years of relevant biotechnology or pharmaceutical industry experience
- >7 years' experience in regulatory affairs; experience leading a regulatory affairs functional group
- Experience in a regulatory lead position for biologics, ideally cell therapies
- Demonstrated expert knowledge and understanding of global regulations and guidelines governing biologics or cell therapies, including preclinical, clinical, CMC, technical development, and manufacturing areas
- Domain expertise of hematology and oncology development including study design, endpoints, etc. Direct lead of lymphoma, multiple myeloma, or solid tumor program regulatory strategy preferred
- Demonstrated track record of successful regulatory submissions including INDs and CTAs, BLA experience preferred
- Mastery of Clinical Compliance, GCPs, and ICH requirements for clinical stage activities.
- Direct evidence of collaborative practice and mindset
- Unquestionable integrity
- Demonstrated leadership and influence skills
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.