Associate Director/Director, Clinical Operations
Company: Eiger BioPharmaceuticals
Location: Palo Alto
Posted on: June 7, 2021
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
Essential Duties and Responsibilities
- Ensure clinical studies are conducted in compliance with FDA
- 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
- 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
- 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
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
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, please visit
Please submit your resume to:
Keywords: Eiger BioPharmaceuticals, Palo Alto , Associate Director/Director, Clinical Operations, Other , Palo Alto, California
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