Associate Director / Director, Clinical Operations (Viral Hepatitis)
Location: South San Francisco, California, United States
The Associate Director / Director, Clinical Operations (Viral Hepatitis) will be responsible for the planning, coordination, oversight and execution of all clinical trials in the assigned development program. You must be willing and able to work at both the trial and program levels to ensure the success of the individual clinical trials and the broader development program. As a senior role within the Clinical Operations group, you will also contribute to the development of policies, Standard Operating Procedures (SOPs), work instructions, best practices and business solutions.
Specific responsibilities include, but are not limited to:
- Responsible for planning, coordinating and aligning activities and communication across multiple clinical trials for assigned development program in the US and ex-US including China
- Oversee the delivery of clinical trials for the assigned development program in compliance with SOPs and with requirements for Clinical Research including US CFR, EU CTD, ICH GCP guidelines and local requirements
- Core member of the of the Program Team, Project Teams and Study Management Teams
- Effectively engage and communicate with functional area leads and stakeholders for the assigned development program
- Identify and anticipate issues related to budget and project milestones and lead mitigation and resolution efforts for issues identified
- Prepare program metrics and dashboard for stakeholders and senior management
- Ensure inspection readiness including an inspection ready TMF for trials within program
- Contribute to document preparation (e.g., protocol and amendments, clinical study reports)
- Support the selection of CROs and vendors and provide program level oversight of CROs and other vendors
- Responsible for forecasting costs for individual clinical trials for the assigned clinical program
- Generate and track clinical trial and clinical program budgets against planned budget and timelines and meet routinely with finance business partners
- Partner with legal and financial functions to negotiate trial contracts and budgets
- Working closely with Project Management, develop and maintain clinical trial and clinical program timelines
- Ensure the CTM/Sr. CTMs create and regularly update study timelines in Microsoft Project and that the study timelines are in sync with the program timelines
- Identify training needs and develop training plans for direct reports, including on-going training
- Responsible for retention, coaching, career development and performance appraisals of direct reports
- Act as a key contributor to the organization cross-functionally to promote organizational goals and knowledge sharing
- Contribute to Clinical Operations policies, SOPs, work instructions, tools and templates, and best practices development
- Lead and drive process improvement initiatives for Clinical Operations
- Assist in the development of the career development program
- Approximately 10% domestic and international travel will be required for this position
- Priority given to candidates with experience in viral hepatitis and working with Asia.
- Bachelor’s degree combined with 12+ years of pharmaceutical/biotechnology clinical operations experience including clinical trial and program management of Phase I-III trials
- Minimum 3 years managing global trials and 3 years monitoring clinical trials
- Subject matter expert in the drug development process
- Trial and program level vendor management experience
- Strong communication skills to ensure that clinical trial and program plans are transparent and risks, issues and results are clear to all stakeholders
- Outstanding organizational skills with the ability to multi-task and prioritize
- Thorough knowledge in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD and ICH GCP guidelines
- Proven line management experience
- Fluency in English in both written and oral communication skills
- Willing to embrace change and work in a changing environment
- Able to work collaboratively across cultures and geographies
- Proficiency in Microsoft® Word, Project, PowerPoint, Excel, Visio
- Global trial management experience in China, India or other countries with high prevalence of HBV and experience managing global virology clinical trials
- Fluency in Mandarin in both written and oral communication skills is desirable, but not required
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. 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.
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.
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