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, you will be responsible for leading and executing risk management and pharmacovigilance (PV) activities for Caribou’s clinical assets. You will oversee the 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:

Leadership & Strategy

• 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.
• He/she will 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.

Safety Surveillance & Risk Management

• 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.

Infrastructure/RM-area build activities

• 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.

Collaboration & Cross-Functional Leadership

• 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.

Operations & Process Improvement

• 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 PV 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.

Training & Communication

• 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).

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.
• Direct experience in a small biotech environment in addition to larger pharmaceutical experience is a plus.
• 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 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 compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $264,000 to $282,000 - 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

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

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. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

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.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc.for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc.  will not be obligated to pay any referral or placement fee.