Senior Director, Clinical Operations

Job Description

Job Description

Description:

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, including type 1 diabetes, 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:

The successful candidate will:

•Lead day-to-day execution of Type 1 diabetes cell therapy clinical studies from start-up through close-out.

•Coordinate endocrinology, transplant, specialty-site, CRO, vendor, and investigational product activities to support treatment readiness and high-quality study conduct. 

•Oversee operational planning, procedural workflows, study documentation, and issue resolution.

•Serve as a key cross-functional operational partner across Clinical Development, Clinical Operations, Translational Medicine, CMC, Quality, Regulatory, Safety, sites, CROs, and vendors; Lead clinical study team meetings.

The work expectation for this role is 1-2 days on-site (preferred). 

The expected annual salary range for this role is approximately $240,000 - $270,000 depending on experience. Additional benefits offered include but are not limited to an annual performance-based bonus (prorated by start date), medical, dental, and vision insurance, matching 401K plan, and 20+ days per-year of PTO (prorated by start date). Additionally, employees not requiring sponsorship are preferred.  

Clinical Trial Operations Oversight:

• Manage operational execution of Type 1 diabetes cell therapy studies, including start-up, enrollment, treatment readiness, maintenance, monitoring, and close-out activities. 

• Coordinate with internal team, CRO, and vendor partners to develop, review, finalize, and maintain study-specific documents, including case report forms, essential documents, site materials, training materials, operational manuals, sample handling instructions, and study plans.

• Support site start-up and activation activities, including IRB/IEC submissions, regulatory document collection and  review, budget and contract coordination, approval tracking, system access, site training readiness, pharmacy or cell therapy unit readiness, and  procedure-day coordination planning.

• Monitor study conduct and quality, including review of monitoring visit reports, oversight of protocol deviations, data queries, laboratory discrepancies, metabolic endpoint data, immunosuppression or immune-monitoring requirements, safety events, and escalation of risks or mitigation plans as appropriate. 

• Participate in site visits, including pre-study, initiation, treatment-readiness, interim monitoring, co-monitoring, and close-out visits, as required. 

• Ensure study supplies, equipment, investigational product handling requirements, metabolic testing materials, biospecimen collection kits, device or monitoring tools, system access, and training requirements are coordinated with sites, CROs, vendors, and internal stakeholders.

• Maintain Trial Master File quality and completeness in partnership with the study lead, CRO, and document management stakeholders.

Qualifications: 

• BS or MS degree in a relevant biological, scientific, technical, or related field; 12+ years of clinical trial management experience with a BS or 10+ years with an MS.

•  Demonstrated experience managing clinical trial execution across start-up, site activation, enrollment, vendor oversight, monitoring, study maintenance, and close-out. 

• Thorough knowledge of clinical research operations, GCP, ICH guidelines, FDA regulatory expectations, and internal SOP compliance.

•  Ability to travel up to 25% as business needs require.  

Preferred Qualifications: 

• Clinical development experience in Type 1 diabetes, endocrinology, islet or beta-cell replacement, metabolic disease, immunology, autoimmune disease, transplant medicine, or other therapeutic areas relevant to a T1D cell therapy program. 

• Experience supporting trials involving cellular therapy, stem-cell-derived islet or beta-cell products, allogeneic cell therapy, iPSC-derived therapeutics, immune effector cell products, CAR-T, transplant procedures, or other complex biologic modalities.

• Familiarity with T1D cell therapy clinical trial considerations, including endocrinology site engagement, C-peptide and mixed-meal tolerance testing, insulin-use assessments, continuous glucose monitoring, HbA1c, hypoglycemia monitoring, immune monitoring, immunosuppression or immune-modulation considerations, procedure-day logistics, safety surveillance, and patient eligibility considerations.  

• Strong track record in endocrinology 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.  

Core Competencies:

• Excellent verbal, written, communication and interpersonal skills.

• 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.