Director of Risk Management and Pharmacovigilance

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Caribou Biosciences

๐Ÿ’ต $230k-$280k
๐Ÿ“Remote - Worldwide

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 Caribouโ€™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), Investigatorโ€™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 Companyโ€™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
This job is filled or no longer available