Tbwa Chiat/Day Inc
Sr. Director/Exec Dir. of Drug Safety & Pharmacovigilance
Tbwa Chiat/Day Inc, California, Missouri, United States, 65018
Sr. Director/Exec Dir. of Drug Safety & Pharmacovigilance
Hybrid, RemoteCaribou 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:As the Senior/Executive Director of Drug Safety and Pharmacovigilance, you will be responsible for leading and executing safety 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 requires deep expertise in drug safety, particularly within hematology-oncology, 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.Collaborate closely with the Chief Medical Officer, clinical development teams, regulatory affairs, and external stakeholders to ensure robust safety management practices.Serve as the primary point of contact for drug safety and pharmacovigilance activities, ensuring compliance with global safety regulations and guidelines.Build 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.Hire, coach, and develop direct reports.Safety Surveillance & Risk ManagementPerform signal detection, investigation, and management, including literature review, analysis of adverse events (AEs), and development of risk mitigation strategies for assigned products.Lead the development and execution of risk management plans (RMP) and risk evaluation and mitigation strategies (REMS) for products in various stages of development.Oversee the medical review of individual case safety reports (ICSRs), safety narratives, and aggregate reports such as PSURs, PBRERs, and PADERs.Regulatory & Clinical OversightContribute 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.Collaborate with regulatory teams to respond to safety inquiries and regulatory agency requests.Support regulatory inspections and audits, including developing and implementing corrective actions when necessary.Collaboration & Cross-Functional LeadershipLead cross-functional safety meetings, collaborating with clinical development, regulatory, and data management teams to ensure alignment on safety-related activities.Partner with CROs and external vendors to ensure compliance with pharmacovigilance agreements and the highest standards of participant safety in clinical trials.Lead reconciliation of safety data between pharmacovigilance and clinical trial databases, ensuring data integrity and accuracy.Operations & Process ImprovementOversee 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.Manage external pharmacovigilance operations, ensuring adherence to performance metrics, timelines, and budget oversight for outsourced safety activities.Training & CommunicationPrepare and deliver safety training and presentations for internal teams, external partners, and investigator meetings, ensuring a comprehensive understanding of safety protocols and responsibilities.Draft and present safety assessments and data to internal stakeholders, safety committees, and independent monitoring boards (DMCs).Qualifications:MD or equivalent degree required, with deep clinical knowledge in hematology-oncology and drug safety/pharmacovigilance.10+ years of experience in drug safety/pharmacovigilance within the biotech or pharmaceutical industry, with strong exposure to hematology-oncology and 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).Experience managing global pharmacovigilance systems, serious adverse event (SAE) reconciliation, and the medical review of safety data.Strong track record of cross-functional leadership and collaboration, with experience overseeing CRO/vendor relationships and safety database management (Argus, MedDRA, WHO Drug).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: $295,000 to $328,000 - 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).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.
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Hybrid, RemoteCaribou 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:As the Senior/Executive Director of Drug Safety and Pharmacovigilance, you will be responsible for leading and executing safety 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 requires deep expertise in drug safety, particularly within hematology-oncology, 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.Collaborate closely with the Chief Medical Officer, clinical development teams, regulatory affairs, and external stakeholders to ensure robust safety management practices.Serve as the primary point of contact for drug safety and pharmacovigilance activities, ensuring compliance with global safety regulations and guidelines.Build 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.Hire, coach, and develop direct reports.Safety Surveillance & Risk ManagementPerform signal detection, investigation, and management, including literature review, analysis of adverse events (AEs), and development of risk mitigation strategies for assigned products.Lead the development and execution of risk management plans (RMP) and risk evaluation and mitigation strategies (REMS) for products in various stages of development.Oversee the medical review of individual case safety reports (ICSRs), safety narratives, and aggregate reports such as PSURs, PBRERs, and PADERs.Regulatory & Clinical OversightContribute 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.Collaborate with regulatory teams to respond to safety inquiries and regulatory agency requests.Support regulatory inspections and audits, including developing and implementing corrective actions when necessary.Collaboration & Cross-Functional LeadershipLead cross-functional safety meetings, collaborating with clinical development, regulatory, and data management teams to ensure alignment on safety-related activities.Partner with CROs and external vendors to ensure compliance with pharmacovigilance agreements and the highest standards of participant safety in clinical trials.Lead reconciliation of safety data between pharmacovigilance and clinical trial databases, ensuring data integrity and accuracy.Operations & Process ImprovementOversee 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.Manage external pharmacovigilance operations, ensuring adherence to performance metrics, timelines, and budget oversight for outsourced safety activities.Training & CommunicationPrepare and deliver safety training and presentations for internal teams, external partners, and investigator meetings, ensuring a comprehensive understanding of safety protocols and responsibilities.Draft and present safety assessments and data to internal stakeholders, safety committees, and independent monitoring boards (DMCs).Qualifications:MD or equivalent degree required, with deep clinical knowledge in hematology-oncology and drug safety/pharmacovigilance.10+ years of experience in drug safety/pharmacovigilance within the biotech or pharmaceutical industry, with strong exposure to hematology-oncology and 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).Experience managing global pharmacovigilance systems, serious adverse event (SAE) reconciliation, and the medical review of safety data.Strong track record of cross-functional leadership and collaboration, with experience overseeing CRO/vendor relationships and safety database management (Argus, MedDRA, WHO Drug).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: $295,000 to $328,000 - 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).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.
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