Title: Director, Drug Safety
Manager: Vice President, Global Clinical Program Lead, Neurology
Department: Clinical Sciences
Location: Richmond, CA or Remote
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.
We are seeking top talent to join our mission. Let’s build a better future together.
JOB SUMMARY:
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.
ESSENTIAL FUNCTIONS:
- 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. This will include system and/or vendor selection, implementation and validation, as needed
EDUCATION, EXPERIENCE AND SKILLS 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
OTHER QUALIFICATIONS:
- 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
We encourage you to apply even if you don’t meet all the qualifications. We believe in the value of diverse perspectives and backgrounds, and we welcome candidates who are eager to learn and contribute to our mission.
Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Pay Range
The anticipated salary range is for candidates who will work in our San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states.
Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves. If you wish to be considered for the presentation of candidates, please email recruiting@sangamo.com. We will reach out to you directly if there is a business need for your services.
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