Director, Drug Safety

Sangamo BioSciences - Richmond or Remote, CA

Full-time - Director

Richmond or Remote, CA

Professional, Scientific, and Technical Services

About the position

Sangamo Therapeutics is seeking a Director, Drug Safety Operations. The primary responsibility will be to implement and manage effective, high quality and efficient processes in compliance with global regulatory requirements and pharmacovigilance best practices. Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases, by using our wholly owned, highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo, we are dedicated to building a robust, sustainable genomic medicine pipeline that addresses life-limiting conditions by replacing today's symptom-focused treatments with tomorrow's genomic cures. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.

Responsibilities

• Provide expert guidance and leadership in Pharmacovigilance and GCP/ICH compliance regulations and guidelines, as well as in applicable Sangamo and/or partner SOPs
• Global safety database oversight including QC of configuration, data-entry conventions and MedDRA dictionary versioning
• Management of workload and resources to meet global regulatory timelines
• Oversight of safety vendors activities
• Provide strategic management and policy proposals for the operations team
• Ensure consistency of work practices across teams both locally and globally
• Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in operations in collaboration with other leaders and stakeholders
• Provide safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop safety reporting procedures and logistics for clinical trials, e.g. reconciliation with clinical database
• Responsible for the oversight, management and communication for all future global business partner safety data exchange agreements and other contracts as applicable and ensure compliance with data exchange activity
• Work with QA/Compliance with respect to inspection readiness and ensure operational procedures and training are compliant with current pharmacovigilance standards
• Develop and maintain SOPs, policies, procedures and standards for case processing
• Ensure compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time
• Interact with global country operations- colleagues related to operational issues/data quality issues
• Partners with other departments including Clinical Operations, Regulatory Affairs, Legal to support clinical, medical and regulatory strategies, company goals as well as to communicate and address drug safety findings
• Assist in the preparation of relevant sections of clinical study reports, aggregate reports (DSUR, Annual Report), expedited safety reports and other regulatory filing documents
• Establish and maintain an electronic global safety database for tracking, storing, and reporting serious adverse events of all Sangamo development and future marketed products

Requirements

• Advanced degree in life sciences, nursing, pharmacy or medicine
• 8+ years experience in global Drug Safety/Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments
• A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP
• A background in implementation and use of drug safety databases as well as extracting required listings and data from
• Effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
• Thorough understanding of the clinical drug development process and drug safety's role therein
• Excellent interpersonal skills, decision-making, and ability to adapt to a dynamic and complex regulatory and business environment
• Commitment to process improvements, excellent organizational skills, excellent written and verbal communication skills, and a strong commitment to best practices, and the ability to work effectively as both a functional area manager as well as cross-functional project team member

Nice-to-haves

• Ability to be independent and move forward processes and work
• Demonstrated leadership to drive results that are needed to achieve company objectives in accordance with Sangamo's culture and core values

Benefits

• Diversity, equity, and inclusion in recruiting and hiring
• Equal opportunity employer
• Commitment to fostering belonging for all employees