Apply on Employer Site

AbelZeta · 4 months ago

Sr Director, Cell Therapy Clinical Operations

Rockville, MD, US

Full-time

Onsite

Director/Executive

$180K/yr - $251K/yr

12+ years exp

AbelZeta is a clinical stage biopharmaceutical company focused on the development of novel immunotherapy products. We are seeking a Senior Director, Clinical Operations to provide strategic and operational leadership for the planning, execution, and delivery of clinical trials across AbelZeta’s pipeline.

BiotechnologyMedicalPharmaceutical

No H1B

Responsibilities

Provide strategic direction and operational oversight for Phase I/II clinical trials, ensuring alignment with corporate goals and regulatory requirements

Develop and implement clinical operations strategies, timelines, budgets, and resource plans for assigned programs

Select, negotiate, and manage CROs and external vendors to ensure quality, cost-effectiveness, and adherence to study deliverables

Establish strong relationships with Principal Investigators (PIs) and study sites, serving as a key point of contact to ensure effective communication, issue resolution, and high-quality trial conduct

Ensure trials are executed in accordance with GCP, FDA, EMA, and other global regulatory requirements; partner with Quality and Regulatory teams to maintain inspection readiness

Collaborate closely within Clinical Development and with Regulatory, Translational Medicine, and CMC functions to enable seamless program execution

Proactively identify operational risks and issues, implementing mitigation strategies to maintain study timelines and quality

Provide regular updates and recommendations to senior leadership on program progress, risks, and resource needs

Other duties as assigned

Qualification

Clinical operations leadershipCellGene therapyRegulatory guidelines knowledgeCRO/vendor managementBudget managementLeadership skillsCommunication skillsDecision-making skillsAdaptability

Required

Advanced degree (MS, PharmD) in life sciences or related field preferred; or Bachelor's degree with extensive experience considered

12+ years of experience in clinical operations, with at least 6+ years in leadership roles in biotech/pharmaceutical settings

Proven track record in successfully leading global Phase I/II trials

Strong understanding of regulatory guidelines (GCP, FDA, EMA)

Demonstrated ability to manage CROs/vendors and complex budgets

Excellent leadership, communication, and decision-making skills

Ability to thrive in a fast-paced, entrepreneurial environment with shifting priorities

Benefits

Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!

Competitive company 401k match.

Paid holidays, sick leave, and annual leave.