DirectorSenior Director Clinical Operations

Cartesian Therapeutics is reimagining cell therapies with transformative technologies to bring a new generation of treatment options to patients with autoimmune diseases.

Position Summary

The Director/Senior Director of Clinical Operations will provide strategic leadership and operational oversight for the execution of key high-priority clinical trial programs within our portfolio specifically focusing on innovative cell therapy programs including CAR-T and trials in autoimmune disease indications. This position is accountable for the successful planning resourcing and flawless execution of these assigned clinical studies in adherence to ICH-GCP FDA regulations and company SOPs. The Director will drive process optimization manage key internal and external relationships (including CROs) and mentor the Clinical Operations team to ensure the delivery of high-quality efficient and timely clinical data within a fast-paced biotech setting.

Key Responsibilities:

• Lead clinical operations strategy and execution for CAR-T and autoimmune disease trials ensuring compliance with GCP regulatory requirements and company SOPs.
• Develop and implement operational plans timelines and budgets for clinical programs.
• Manage CROs and external vendors ensuring quality deliverables and adherence to timelines.
• Collaborate cross-functionally with senior leadership to ensure operational initiatives support broader strategic priorities including growth technology adoptions and provider engagement.
• Drive process improvements by introducing best practices from larger organizations or CRO experience to enhance efficiency and scalability.
• Oversee site selection initiation and monitoring ensuring strong relationships with investigators and key opinion leaders.
• Provide medical and scientific input into protocol development safety reviews and clinical trial conduct.
• Mentor and develop clinical operations team members fostering a culture of excellence and accountability.

Education and Experience:

• Advanced degree (MD PhD or PharmD) with a minimum 10 years of progressive experience within a clinical research environment and at least 5 years in a supervisory or management capacity.
• Experience in the therapeutic area of Rheumatology Immunology and/or autologous cell therapy is strongly preferred.
• Proven expertise in leading and managing complex operational projects or multi-site clinical trials from inception through completion.
• Demonstrated proficiency in developing managing and controlling large operational budgets and vendor contracts (e.g. CROs clinical suppliers).
• Deep working knowledge and application of relevant ICH-GCP and FDA regulatory standards quality assurance and Standard Operating Procedures (SOPs).
• Strong track record of leading mentoring and developing high-performing clinical or operational teams.

Skills:

• Strategic Leadership: Proven ability to define strategy and translate organizational vision into actionable compliant and efficient clinical operational plans.
• ICH-GCP/Regulatory Expertise: Deep working knowledge and application of ICH-GCP and FDA regulatory requirements to ensure clinical trial integrity and compliance.
• Financial & Resource Management: Expertise in clinical trial budgeting cost control vendor contract negotiation and efficient allocation of resources.
• Process Improvement: Strong track record of developing and implementing SOPs to optimize clinical workflows enhance quality and drive operational efficiency.
• Team & Vendor Management: Demonstrated success in leading mentoring and developing diverse clinical teams and providing effective oversight of Contract Research Organizations (CROs).

Salary Notice:

At Cartesian Therapeutics we are committed to transparency and equity in our compensation practices. The salary range for this position is $214000 - $295000 per year. This position is also eligible for an annual bonus and equity within the company. Please note that the final compensation will be determined based on several factors including but not limited to years of experience industry experience education and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process.

Benefits

Health & Wellness

• Comprehensive medical dental and vision insurance
• Prescription drug coverage
• Mental health support and Employee Assistance Program (EAP)

Financial & Retirement

• 401(k) plan with company match
• Life and disability insurance
• Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA)

Paid Time Off

• Generous vacation and sick leave
• Paid holidays
• Parental leave

Work-Life Balance

• Flexible work arrangements
• Wellness programs

Professional Development

• Tuition reimbursement or education assistance
• Training and career development opportunities
• Conference attendance support

Other Perks

• Employee recognition programs
• Company-sponsored events
• Commuter benefits or transportation assistance

Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race color age religion sex sexual orientation gender identity national origin ancestry disability marital status genetic information military status or any other characteristic protected under applicable law.

Required Experience:

Exec