What are the responsibilities and job description for the Head of Clinical Safety and Development position at Cartesian Therapeutics?
Job Description
Job Description
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, cross-functional teams, and external stakeholders to drive the successful execution of our programs.
Key Responsibilities :
- 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, risk-benefit 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 autoimmunity-related risks.
- Serve as the primary safety liaison to regulatory authorities (FDA, EMA, PMDA, etc.) , ensuring compliance with global safety reporting requirements.
- 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 1-3) 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.
- Cross-Functional Leadership & Strategic Influence
- Provide clinical and safety leadership to cross-functional 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 :
Preferred Attributes
Salary Notice :
At Cartesian Therapeutics, we are committed to transparency and equity in our compensation practices. The salary range for this position is $280,000 to $395,000 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.
Salary : $280,000 - $395,000
