Director of Risk Management and Pharmacovigilance

Summary

Join Caribou Biosciences as their Director of Risk Management and Pharmacovigilance, reporting to the CMO. You will lead and execute risk management and pharmacovigilance activities for Caribou’s clinical assets, overseeing safety surveillance from Phase 1 through BLA submission. This role involves collaborating with internal and external stakeholders to ensure patient safety and building a risk-management infrastructure. As the first PV hire, you'll have the opportunity to expand your expertise and manage other PV areas. Deep expertise in risk management and signal surveillance within hematology-oncology and immune-oncology is crucial. This position is key to Caribou's mission of delivering safe and transformative therapies.

Requirements

• MD or equivalent degree required
• 10+ years of experience in drug safety/pharmacovigilance within the biotech or pharmaceutical industry, with at least 5 years of direct experience in risk management in a global setting is preferred
• Direct experience in hematology-oncology or equivalent required; direct CAR T experience or cell therapy preferred
• Proven expertise in signal detection, risk management strategies, and benefit-risk assessments across all phases of clinical development
• In-depth knowledge of global pharmacovigilance regulations (FDA, EMA, ICH) and industry standards, including Good Pharmacovigilance Practices (GVP)
• Demonstrated experience managing more junior PV personnel and PV vendor (s)
• Global responsibilities in previous role (s)
• The successful candidate must be well-organized, have strong leadership skills as well as an ability to work effectively in a remote-based role
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across departments and with external stakeholders
• Solution-oriented mindset with strong problem-solving and decision-making skills
• Demonstrated leadership in regulatory safety submissions and responses, including contributing to BLAs, INDs, and safety assessments

Responsibilities

• Lead and manage safety surveillance and pharmacovigilance (PV) activities for clinical programs, including proactive risk management strategies, signal detection, and benefit-risk analysis across all stages of development
• Partner with CMO to co-chair a multidisciplinary safety committee (i.e. Pharmacovigilance /safety decision-making venue), that reviews select individual serious adverse event cases and aggregate adverse event data for trends, as well as signal detection summaries from all studies
• Collaborate closely with the Chief Medical Officer, clinical development teams, regulatory affairs, and external stakeholders to ensure robust safety management practices
• Partner with existing PV consultant team on all areas of PV Operations including vendor management, business process optimization, SOP development, alliance partnerships, personnel /hiring and PV dept scale-up to support pivotal phase/commercial scale-up and inspection readiness
• Actively contributes to building safety capabilities internal to Caribou as the company and programs grow and move to the next phase of development
• Implement cost-savings and efficient cross-program processes that ensure safe, compliant practices
• Serve as the primary point of contact for drug safety and pharmacovigilance activities with strong operational support by existing PV consultant team, ensuring compliance with global safety regulations and guidelines
• Hire, coach and develop direct reports within Risk Management; may advise with broader PV hiring strategy
• Define and lead the strategic development of Risk Management area processes (i.e. SOPs), medical evaluation of safety information and risk management activities to assure compliance with global health regulations
• Perform signal detection, investigation, and management, including literature review, analysis of adverse events (AEs), and development of risk mitigation strategies for assigned products
• Work closely with Regulatory Affairs, Clinical Development and affected business partners, as applicable, to define a strategy on responses to questions from FDA and global health authorities
• Lead the development and execution of risk management plans (RMP) and risk evaluation and mitigation strategies (REMS) for products in various stages of development
• Assess existing safety data collection practices and risk communication across relevant clinical documents to assure alignment and consistency across programs
• Contribute to safety sections of regulatory submissions, including Investigational New Drug (IND) applications, BLAs, protocols, informed consent forms (ICFs), Investigator’s Brochures (IBs), and other key clinical trial documents
• May lead/ oversee the medical review of individual case safety reports (ICSRs), safety narratives, and authorship of aggregate reports such as PSURs, PBRERs, and PADERs
• Demonstrated ability to lead PV personnel (RM) recruitment effort and functional area (i.e. Risk Management) build plan as the company model evolves
• Lead development of relevant SOPs to include safety monitoring procedures that assure oversight of safety decision-making/governance in the context of an outsourced PV vendor model
• Support regulatory inspections and audits, including developing and implementing corrective actions when necessary
• Lead cross-functional safety meetings, collaborating with clinical development, regulatory, and data management teams to ensure alignment on safety-related activities
• Support the preparation of safety-related sections for clinical and regulatory documents (i.e. protocols, clinical study reports, IND/annual reports, integrated summaries of safety)
• Collaborate with existing PV consultant team to oversee CROs and external vendors to ensure compliance with pharmacovigilance agreements and the highest standards of participant safety in clinical trials
• Oversee the safety review process, including coding review, safety signal evaluation, and expedited regulatory reporting, ensuring compliance with FDA, EMA, and ICH regulations
• Drive continuous improvement of PV systems and processes, contributing to the development and revision of SOPs, contracts, and agreements related to safety activities
• May provide input to existing P V consultant team to manage external pharmacovigilance operations, ensuring. , ensuring adherence to performance metrics, timelines, and budget oversight for outsourced safety activities
• Support regulatory inspections and audits, including developing and implementing corrective actions when necessary
• Prepare and deliver safety training and presentations for internal teams, external partners, and investigator meetings, ensuring a comprehensive understanding of safety protocols and responsibilities, as applicable
• Draft and present safety assessments and data to internal stakeholders, safety committees, and independent monitoring boards (DMCs)

Preferred Qualifications

Direct experience in a small biotech environment in addition to larger pharmaceutical experience is a plus

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $230,000 to $280,000 - This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program