Director of Risk Management and Pharmacovigilance

Caribou Biosciences; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Risk Management and Pharmacovigilance to lead critical safety initiatives in the biopharmaceutical sector. This role offers a unique opportunity to build a risk-management infrastructure, ensuring patient safety while collaborating with cross-functional teams. The ideal candidate will possess deep expertise in risk management within the hematology-oncology field and will be instrumental in advancing the company's mission to deliver transformative therapies. Join a forward-thinking organization that values diverse perspectives and fosters professional growth in a dynamic environment.

Benefits

Flexible Work Hours

Remote Work Opportunities

Professional Development Programs

Health Insurance

Paid Time Off

Retirement Plan

Wellness Programs

Qualifications

• 10+ years in drug safety/pharmacovigilance, with 5+ years in risk management.
• In-depth knowledge of global pharmacovigilance regulations and GVP.

Responsibilities

• Lead safety surveillance and pharmacovigilance activities for clinical programs.
• Collaborate with CMO and multidisciplinary safety committee on adverse events.

Skills

Leadership Skills

Problem-Solving Skills

Communication Skills

Interpersonal Skills

Risk Management

Signal Detection

Decision-Making Skills

Education

MD or PharmD

Tools

Pharmacovigilance Systems

Job description

Director of Risk Management and Pharmacovigilance

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. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

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 offers the opportunity to build a risk-management infrastructure in a fast-paced, challenging therapeutic area. As the first PV hire, this individual has the opportunity to learn and manage other areas within PV (operations, vendor management, systems, compliance) for enhanced growth and learning while working with an existing PV consultant team.

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, 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 contribute 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.

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 is preferred.
• Direct experience in hematology-oncology or equivalent is required; direct CAR T experience or cell therapy is 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).
• The successful candidate must be well-organized, have strong leadership skills as well as the 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.

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 (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.