Associate Director/Director Clinical Operations
The Associate Director/Director, Clinical Operations is responsible for the strategic planning, oversight and execution of Ph1/II/III studies across indications or programs. The Associate Director/Director, Clinical Operations will have program oversight responsibilities while also managing a study or studies. Responsibilities include, but are not limited to, establishing program study timelines and budgets, overseeing the day-to-day operations of clinical trials from study design through close-out, ensuring studies are conducted in accordance with appropriate regulatory requirements and within established timelines and budget, leading cross-functional teams and managing relationships with investigator sites, vendors and consultants. The Associate Director/Director, Clinical Operations is also responsible for leading or contributing to company process improvement initiatives.
Essential Duties and Responsibilities
- Ensure clinical studies are conducted in compliance with FDA regulations, ICH
- Accountable for the operational delivery of responsible studies within one program or across programs, overseeing cross-functional alignment, budget, and timelines.
- Participate in program strategy meetings, contributing the operational strategy of responsible program/studies.
- Leads efforts for the selection and oversight of external service providers, including CROs and other vendors as necessary.
- Develops and manages clinical trial budgets, providing ongoing financial reporting and forecasting; oversees budgets and timelines for responsible program.
- Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary.
- Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
- Independently manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP’s and GCP, and coordinates cross functional efforts to achieve study objectives and goals.
- Identifies and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads as needed.
- Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
- Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites.
- Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
- Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
- Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
- Ensures Trial Master File is accurate and up to date.
- Mentors more junior team members.
- Leads and/or contributes to department initiatives, and assists in the design and implementation of standardized work processes.
- Bachelor's degree in a scientific discipline and a minimum of 10 of years of experience in clinical research working in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.
- Experience working in Phase I, II and II in a variety of different study types, vendors and geographies
- Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
- Expertise in Microsoft Word, PowerPoint, and Excel is required and experience with Microsoft Project.
- Working knowledge of Good Clinical Practice (GCP).
- Available for minimal travel (<30%) including overnight stays, when required.
- Ability to drive and have a valid driver’s license.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, well-tolerated type III interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.