Director of Risk Management and Pharmacovigilance

Caribou Biosciences, Inc.; United States; Hybrid; USD 100,000 - 125,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Director of Risk Management and Pharmacovigilance to lead safety surveillance and risk management for clinical assets. This pivotal role involves overseeing pharmacovigilance activities, collaborating with cross-functional teams, and ensuring compliance with global safety regulations. The ideal candidate will have extensive experience in drug safety within the biotech or pharmaceutical industry, particularly in hematology-oncology. Join a forward-thinking organization dedicated to developing transformative therapies and make a significant impact on patient safety and care.

Qualifications

• 10+ years in drug safety/pharmacovigilance in biotech/pharma.
• Direct experience in hematology-oncology or CAR T preferred.

Responsibilities

• Lead safety surveillance and pharmacovigilance activities for clinical programs.
• Collaborate with CMO and regulatory affairs for safety management.

Skills

Risk Management

Pharmacovigilance

Signal Detection

Benefit-Risk Assessment

Communication Skills

Education

MD or PharmD

Tools

Clinical Development Software

Job description

Director of Risk Management and Pharmacovigilance

Hybrid, Remote

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases.

Position Summary:
Reporting to the CMO, the Director of Risk Management and Pharmacovigilance will be responsible for leading and executing risk management and pharmacovigilance (PV) activities for Caribou’s clinical assets. You will oversee safety surveillance and risk management from Phase 1 through BLA submission and collaborate cross-functionally with internal teams and external stakeholders to ensure the highest standards of patient safety.

This role requires deep expertise in risk management/signal surveillance, particularly within the hematology-oncology and immune-oncology arena and will play a key role in Caribou’s efforts to deliver safe, transformative therapies to patients.

Key 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 that reviews select individual serious adverse event cases and aggregate adverse event data for trends.
• 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, and PV department scale-up.
• Actively contribute to building safety capabilities internal to Caribou as the company and programs grow.
• 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, ensuring compliance with global safety regulations and guidelines.
• Hire, coach and develop direct reports within Risk Management; may advise on broader PV hiring strategy.

Qualifications:

• MD, PharmD 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 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.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across departments.

Working Conditions:

• Primarily computer-based, remote work with onsite requirements as needed for collaboration.
• Expected travel of approximately 10% to attend meetings, clinical trial sites, and regulatory inspections.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender, or any other basis protected by law.

Legal authorization to work in the United States is required.