Position Overview

We are currently seeking a highly motivated, experienced individual for the position of Associate Director of QC and AD. The position is responsible for supporting QC activities for Eiger projects. The ideal candidate will have demonstrated knowledge in Quality Control execution, stability program management, method qualification/validation/transfer and reference standard inventory management. The position reports to the Senior Director of Quality Control and Analytical Development.

Essential Duties and Responsibilities

  • Manage method qualification/validation/transfer activities for starting material, intermediate, drug substance and drug product at CMOs
  • Support timely review and QC of analytical data packages for drug substance (DS) and drug product (DP) release
  • Generate release and stability specifications for starting materials, intermediates, drug substances, and drug products
  • Manage DS and DP stability programs, timelines, and corresponding shelf-life determination
  • Lead preparations of stability sections for regulatory submissions
  • Support laboratory investigations for deviations, OOS/OOTs, determine root cause analysis and CAPAs for analytical issues
  • Oversees qualification of reference materials and management of their inventory and supply across testing sites
  • Support QC data management in Eiger e-QMS

Position Requirements

  • Bachelor’s degree in Chemistry, Biochemistry or a related field is required
  • 8+ years of experience in pharmaceutical or biotechnology industry with at least 5 years in quality control laboratories or related quality control area
  • Broad knowledge of analytical techniques including HPLC, GC, compendial methodologies etc. for small molecules and biologics
  • Strong knowledge in regulatory, ICH and cGMP requirements pertaining to biotechnology and pharmaceutical industries required
  • CMO based QC management experience
  • Experience with IND/NDA and IMPD/MAA submissions
  • Experience in late-stage drug development is preferred
  • Proven track record in applying analytical techniques to solve challenging problems
  • Collaborative nature required
  • Very strong organizational abilities and communication skills
  • Self-directed, independent

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

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.

Please submit your resume to:

[email protected]

Position Overview

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.

Position Requirements

  • 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).

TRAVEL REQUIRED

  • Available for minimal travel (<30%) including overnight stays, when required.
  • Ability to drive and have a valid driver’s license.

EOE

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, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Summary Description

We seek an experienced Purchasing Manager who can join our team to develop and drive the Purchasing Operation and strategies across our organization. In this role, you will be the first full time purchasing employee. You will help establish the purchasing organization including refining policies, communicating authorization limits and encouraging effective use of our cloud-based procurement system Coupa.

In this role, you should be versatile with a "roll up the sleeves" mentality, excellent customer service skills, and able to move forward with minimal direct supervision. In this role, you will report to our Vice President and Corporate Controller.

Essential Duties & Responsibilities

  • Manage the process of Purchase Requests to Purchase Orders.
  • Create Purchase Orders for relevant internal stakeholders, coordinate based on supplier's conditions.
  • Work with CMC/ Tech Dev supply chain team to meet production deadlines and ensure purchase orders are placed for the procurement of production and non-production material, components and/or services, as required by forecasts, production schedules or authorized purchase requests.
  • Encourage and coordinate early supplier involvement on technical sourcing for supply commodity using the suppliers' expertise to optimize quality, cost, and manufacturability
  • Ensure cloud based Coupa maintains functionality with company’s ERP NetSuite.
  • Identify savings projects within the sites and negotiate cost savings for all Procurement categories.
  • Regularly evaluate the cost and quality performance benchmarks and the risks associated with the preferred supply base selection.
  • Create and monitor metrics in line with KPI objectives.

Qualification Requirements

  • Bachelor's degree in Supply Chain Management, Business Management, or equivalent experience.
  • 3-5+ years of relevant procurement or supply chain management experience, experience in biotech or Pharma is preferred.
  • Experience in ERP data reporting and KPI generation will be very helpful.
  • Public company experience is helpful.
  • Requires excellent analytical and written/oral communication skills.
  • Able to build partnerships and excel cross functionally with CMC/ Tech Dev, Clinical Operations, Supply Chain, Finance and other departments
  • Positive mindset, can-do attitude and able to work with all levels within

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, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Position Overview

The Sr. Clinical Trial Manager (sCTM)/Associate Director (AD), Clinical Operations is responsible for the strategic planning, oversight and execution of Ph1/II/III studies across indications or programs. The sCTM /AD of 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 sCTM /AD of 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.

Position Requirements

  • 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).

TRAVEL REQUIRED

  • Available for minimal travel (<30%) including overnight stays, when required.
  • Ability to drive and have a valid driver’s license.

EOE

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 (Nasdaq:EIGR) is a publicly-traded, commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. 

Eiger is developing two complementary treatments for HDV.  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 approval.  A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).  Outside the U.S., Eiger's established global Managed Access Program, expected to span greater than 40 countries, ensures all children and young adults with Progeria and Progeroid Laminopathies have access to treatment.

For additional information about Eiger, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Essential Duties & Responsibilities

  • Develop global Chemistry, Manufacturing, and Control (CMC) regulatory strategies and dossier content plans related to product clinical trial and marketing applications for pre- and post-approval submissions in all global markets, including regulatory risk assessments and mitigations associated with proposed strategies
  • Create high quality, compliant CMC regulatory documents (eg, Core Dossiers, INDs, CTAs, MAAs, BLA) and support in responding to health authority questions within defined timelines
  • Lead development and execution of global product and project regulatory strategies by overseeing development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Maintain up-to-date understanding of global product and medical device regulations and guidance documents and advise cross-functional project teams on the interpretation and application of health authority expectations toward product and drug-device combination submissions.
  • Raise issues and promote strategies to Senior Management that affect registration, regulatory compliance and continued lifecycle management related to Quality submissions.
  • Deliver all regulatory milestones across the multiple product lifecycles

Position Requirements

  • A Bachelor’s/undergraduate degree is required.
  • An engineering, biological, pharmaceutical, or chemical sciences degree is preferred. A M.S. or Ph.D. degree is preferred.
  • A minimum of 10 years of experience in the pharmaceutical, medical device, or healthcare industry is required.
  • A minimum of 4 years of experience developing or contributing to global regulatory strategies while working in a regulatory affairs or related function (i.e. R&D, quality, reg compliance) is required
  • Experience developing drug-device combination products is preferred.
  • Experience in preparing for and/or leading Health Authority meetings (FDA, EMA and other health authorities) is required.

About Eiger BioPharmaceuticals, Inc.

Eiger (Nasdaq:EIGR) is a publicly-traded, commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. 

Eiger is developing two complementary treatments for HDV.  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 approval.  A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).  Outside the U.S., Eiger's established global Managed Access Program, expected to span greater than 40 countries, ensures all children and young adults with Progeria and Progeroid Laminopathies have access to treatment.

For additional information about Eiger, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]