Associate Director, Clinical Operations
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 AD of Clinical Operations will be responsible for: assisting with the management of clinical operations team members and clinical trials; providing strategic clinical operations input; leading the clinical operations efforts; working closely with the Chief Medical Officer; helping to plan, implement and manage clinical trials according to timelines, budget and applicable regulations; providing senior-level support and guidance to the clinical operations study team; building and maintaining relationships with clinical investigators, advisors, and thought leaders; collaborating with key stakeholders internally and externally to understand the global hepatitis B landscape, will leverage this knowledge for the benefit of the program, and have a deep understanding of the operational considerations when executing studies in various regions of the world; and ensuring that all studies are executed in accordance with applicable government regulations as well as with ICH/GCP guidelines.
Specific responsibilities include, but are not limited to:
- Provide direction, oversight and execution of all aspects of clinical trials
- Work with clinical operations team members on the CRO and critical vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines, and ensure that performance expectations and deliverables are met
- Address and/or escalate to the Head of Clinical Operations and CMO, on any significant study issues
- Work with the Head of Clinical Operations to forecast and manage project/program budgets
- Lead the budget negotiation process and finalization with clinical vendors and clinical trial sites. Develops and manages clinical trial budgets; proactively provide the Head of Clinical Operations with necessary updates on progress and changes in scope, schedule, and resources in a timely manner
- Serve as the point of contact for issues escalation and resolutions on assigned projects
- Review/approve vendor invoices and manage payment process
- Manage up to 1-3 direct reports providing mentorship and project work guidance
- A minimum of a Bachelor’s degree in a relevant scientific discipline is required. An Advanced Degree is preferred
- A minimum of 12+ years of progressive experience in Clinical Operations with a thorough understanding of cross-functional clinical processes including clinical supply, data management, biostatistics, and medical writing; previous field experience as a CRA preferred
- At least 4+ years of clinical operations line management experience
- In-depth knowledge of clinical operations, including interpretation and implementation of ICH/GCP guidelines, is required
- Broad experience in effective vendor management and selection is required
- Computer skills including proficiency in the use of Microsoft Word, Excel, Project, PowerPoint, and other organization tools. Proficiency in SharePoint with filing systems is highly desirable
- Ability to travel up to 10% domestically
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.