Associate Director, Clinical Operations - Systems & Quality

South San Francisco, CA, United States
Aug 08, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
As the Associate Director of Clinical Operations Systems & Quality, you will be responsible for an ongoing assessment of Assembly Biosciences Clinical Operations infrastructure and the development and implementation of continual process improvement and associated training programs. You will lead the development and implementation of polices, Standard Operation Procedures (SOPs) and work instructions for Clinical Operations and in collaboration with other functional stakeholders and end users at Assembly Biosciences. You will also be responsible for the identification and implementation of business solutions to improve efficiency and ensure overall compliance with ICH GCP and applicable regulatory requirements.

Specific responsibilities include, but are not limited to:
  • Ongoing assessment and implementation of Clinical Operations infrastructure and an associated process improvement plan
  • Provide metrics to show impact of process improvement efforts
  • Lead, develop and implement SOPs for Clinical Operations considering affiliate stakeholders and regulations in all relevant territories as the processes are being developed
  • Develop and deliver a SOP training program for Clinical Operations staff
  • Oversee the career development and training program for Clinical Operations staff
  • Create and maintain project and program timelines to ensure internal stakeholders and external vendors are meeting agreed upon timelines and escalating any risks to project completion
  • Lead GCP inspection readiness activities in coordination with the Head of Clinical Operations and Compliance
  • Act as a key cross-functional contributor to the organization, promotes and supports organizational goals and knowledge sharing
  • May manage direct reports and is responsible for retention, coaching, and performance appraisals of direct reports
  • Approximately 10% domestic and international travel will be required for this position

Preferred Experience:
  • Bachelor's degree
  • 12+ years of pharmaceutical/biotechnology/CRO in quality management of clinical trials, training, clinical operations, project management
  • Subject matter expert in the clinical drug development process
  • Thorough knowledge of ICH GCP guidelines and applicable drug development regulations
  • Experience managing quality and ICH GCP compliance
  • Experience leading the development of SOPs and other process related documentation
  • Has led GCP inspection readiness activities and participated in regulatory authority inspections
  • Global study conduct, quality management and/or training experience in China, India or other countries with high prevalence of HBV
  • Fluency in Mandarin in both written and oral communication skills is desirable but not required
  • Strong project management skills and technical writing skills
  • Line management experience
  • Willing to embrace change and work in a changing environment
  • Able to work collaboratively across cultures and geographies
  • Fluency in English in both written and oral communication skills
  • Proficiency in Microsoft® Word, Project, PowerPoint, Excel, Visio

About Assembly:

Assembly Biosciences (NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly's fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL ® technology. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team great people who are driven to transform the lives of patients.

We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn's disease and Irritable Bowel Syndromes with potential total development and commercial milestones of up to $2.8 billion. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.

Assembly is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.

AAP/EEO Statement

Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.