Head of Clinical Safety and Development

Cartesian Therapeutics Inc. is reimagining cell therapies with transformative technologies to bring a new generation of treatment options to patients with autoimmune diseases. The Head of Clinical Safety and Development will lead the clinical safety and development strategy for our cell therapy programs integrating pharmacovigilance oversight with clinical protocol development. This executive will be responsible for ensuring the safety of patients in our trials while shaping the clinical development strategy for our pipeline. The VP will serve as a key leader within the clinical organization interfacing with regulatory agencies crossfunctional teams and external stakeholders to drive the successful of our programs.

Key Responsibilities:

1. Clinical Safety & Pharmacovigilance Oversight

• Lead safety strategy for cell therapy programs ensuring robust risk management across all clinical trials.
• Oversee pharmacovigilance operations including safety signal detection riskbenefit assessments and regulatory safety reporting (e.g. SUSARs DSURs PSURs).
• Chair the Safety Review Committee and liaise with Data Monitoring Committees (DMCs) to ensure proactive safety governance.
• Develop and refine risk mitigation strategies tailored to cell therapy including cytokine release syndrome (CRS) neurotoxicity and autoimmunityrelated risks.
• Serve as the primary safety liaison to regulatory authorities (FDA EMA PMDA etc. ensuring compliance with global safety reporting requirements.

1. Clinical Development & Protocol Design

• Drive the clinical development strategy ensuring alignment with regulatory requirements scientific advances and market needs.
• Lead the design of clinical trial protocols (Phase 13 for cell therapy in autoimmune indications incorporating innovative trial designs where applicable (e.g. adaptive trials basket studies).
• Collaborate with translational science teams to integrate biomarkers and mechanistic insights into clinical development plans.
• Work closely with regulatory affairs to develop clinical sections of regulatory submissions including INDs BLAs and briefing documents.
• Serve as a key medical expert in KOL engagement supporting external collaborations and publications.

1. CrossFunctional Leadership & Strategic Influence

• Provide clinical and safety leadership to crossfunctional teams including clinical operations regulatory CMC and commercial teams.
• Represent the company in regulatory meetings advisory boards and scientific conferences to advance our clinical programs.
• Contribute to corporate strategy advising on asset prioritization and pipeline expansion opportunities in autoimmune diseases.
• Foster a culture of medical and scientific excellence mentoring clinical development and pharmacovigilance teams.

Qualifications:

• MD or equivalent (required) with board certification in rheumatology neurology hematology or immunology preferred.
• 10 years of clinical development experience in biotech/pharma with a track record in autoimmune diseases cell therapy or immunology.
• Proven expertise in pharmacovigilance and clinical safety in advanced therapies.
• Deep understanding of global regulatory requirements for cell and gene therapy (e.g. FDA EMA ICH GVP).
• Experience leading clinical trial design and in Phases 13.
• Strong leadership skills with the ability to engage internal and external stakeholders including regulators investigators and KOLs.
• Exceptional communication skills with the ability to translate complex safety and development strategies to diverse audiences.

Preferred Attributes

• Prior experience in myasthenia gravis SLE or related autoimmune disorders.
• Experience in firstinhuman (FIH) and earlyphase cell therapy trials.
• Strong scientific background with a track record of publications and conference presentations.

Salary Notice:

At Cartesian Therapeutics we are committed to transparency and equity in our compensation practices. The salary range for this position is $280000 to $395000 per year. Please note that the final salary 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.

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:

Director