Senior Clinical Trial Manager
Position Title: Clinical Trial Manager/Senior Clinical Trial Manager, Clinical Operations
Reports to: Senior Director, Clinical Operations
Status: Regular, Full-Time, Exempt
Location: San Francisco, CA
Summary: Assembly Biosciences (NASDAQ symbol ASMB) is a clinical-stage biotechnology company advancing two innovative platform programs: a Hepatitis B-Cure program consisting of a new class of oral therapeutic candidates for the treatment of hepatitis B virus (HBV) infection and a novel class of oral synthetic live biotherapeutic candidates, which are designed to treat disorders associated with the Microbiome.
The HBV pipeline consists of a lead program in multiple global Phase 2a studies; a 2nd Generation program entering Phase I late this year, and a 3rd program approaching clinical candidate selection. We expect this pipeline to represent a backbone therapy for increasing cures in HBV, and can be envisioned as a foundation of the company’s research in virology globally.
The Microbiome platform consists of our lead programs in GI, partnered with Allergan, nearing the first IND/Phase Ib later this year and early next for Ulcerative Colitis, and a pipeline of other disease areas in consideration for advancement that are wholly owned by ASMB.
The Company has a strong balance sheet having recently raised $166 million, bringing its cash reserves to approximately $250 million – and thus positioned well to build the next phase of Assembly toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
The Clinical Trial Manager (CTM)/Senior Clinical Trial Manager (Sr CTM) should be able to independently manage all components of a clinical trial, leading a multidisciplinary, cross- functional Study Management Team. The CTM/Sr CTM is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements.
Specific responsibilities include, but are not limited to:
The Clinical Trial Manager/Senior Clinical Trial Manager will be responsible for:
- Serving as a key operational contact with external investigators and internal stakeholders, for successful implementation of studies
- Providing critical evaluations of operational feasibility of scientific proposals and clinical protocols
- Establishing strong cross-functional relationships and providing strong leadership skills with counterparts in other internal functional teams to ensure efficient execution of study management processes
- Proactively identifying potential operational challenges and - in collaboration with senior team members - providing timely resolution plans to ensure study remains on track
- Implementing and maintaining working processes to promote high quality, efficient, and compliant systems and tools for study management
- Maintaining a good understanding of industry standards and regulations for studies and keeping abreast of any potential changes and developments impacting clinical operations
- Drafting and coordinating the review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports
- Must be able to understand, interpret and explain protocol requirements to others
- Maintaining study timelines
- Coordinating review of data listings and preparation of interim/final clinical study reports
- Contributing to the development of RFPs and participating in selection of CROs/vendors
- Mentoring and developing junior clinical operations staff
- Thorough knowledge of FDA and ICH Guidelines, and GCP governing the conduct of clinical studies
- Creation and maintenance of high quality internal Clinical Operations databases and document repositories for ongoing and new clinical programs
- Must be able to resolve clinical study related problems using national and international regulations, guidelines, and investigator interaction
- Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements
- A minimum of a Bachelor’s degree is required (life science degree is preferred)
- A minimum of 5+ years (for CTM level) or 7+ years (for Sr CTM level) of progressive experience in Clinical Operations overseeing trials and trial management
- Thorough knowledge of clinical monitoring practices
- In-depth knowledge of clinical operations, including interpretation and implementation of ICH/GCP guidelines
- Broad experience in effective vendor management and selection
- Computer skills including proficiency in the use of Microsoft Word, Excel, Project, PowerPoint, and other organization tools
- Ability to prioritize and manage multiple tasks and tight timelines.
- Demonstrated self-starter and team player
- Adaptable to a dynamic environment
- Highly detail-oriented
- Strong interpersonal and organizational skills
- Excellent written and verbal skills
- Experience in infectious diseases (especially hepatitis B-related) trials is preferred
Travel: Ability to travel up to 15%
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.