Director/Senior Director Clinical Operations
Cartesian Therapeutics, Inc., Frederick, Maryland, United States, 21701
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 $214,000 - $295,000 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.
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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 $214,000 - $295,000 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.
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