Careers

Job Description

Reporting to the Senior Director, CMC Regulatory Affairs, the Associate Director/Director, CMC Regulatory Affairs is responsible for leading regulatory support for assigned programs in small molecules, biologics and peptides to ensure sound regulatory planning and tactical implementation of US and international development and marketing authorization strategies.

Responsibilities include, but not limited to:

• Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams
• Identifies the required documentation and any content, quality and timeline issues for global submissions and negotiates the delivery of approved technical documents in accordance with project timelines
• Manages the preparation, authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications, as well as post-marketing variations
• Supports the evaluation of manufacturing changes for the potential impact on products
• Provides expert review of CMC documentation supporting regulatory submissions and communications
• Coordinates preparation of responses to queries from regulatory authorities, particularly focused on CMC
• Maintains up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
• Ensures conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs
• Provides regulatory advice to other functional areas
• Participates in regulatory due diligence activities

Relationships:

• Builds and maintains collaborative relationships with external business partners to achieve project regulatory goals
• Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
• Develops and manages relationships with external vendors and regulatory health authorities
• Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
• Collaborates with regulatory colleagues to provide CMC expertise as needed

Minimum Skills/Knowledge Required:

• 8+ years of drug development, including 5+ years of regulatory affairs CMC experience in the Biotech/Pharmaceutical industry; experience in small molecule, biologics and peptides is desirable.
• Bachelor’s degree is required, preferably in chemistry or a closely related field; advanced degree is a plus
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Solid working knowledge of core processes: discovery, development, and manufacturing of small molecules and biologics
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus
• Ability to work effectively across teams, functions and with outside partners
• Excellent oral and written communication skills

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

Eiger BioPharmaceuticals is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Eiger has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment.  If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Job Description

Reporting to the General Counsel, the Associate Director—Legal Operations, Contract Administration and Compliance will work closely with services and technology providers and outside legal counsel to develop and maintain the Company’s corporate legal systems, policies and processes, and will be responsible for supporting the entire contracting process, including preparation, review, tracking, execution and storage of company contracts.  This role will also support the corporate compliance function, ensuring the company meets its obligations with regard to payments to HCPs, adheres to its internal controls and appropriately trains employees, contractors and vendors.  This individual will provide critical client support activities to internal stakeholders throughout the company.  The successful candidate will be nimble and highly self-motivated, with excellent organizational and communication skills, the ability to handle multiple projects and work with a diverse group of legal and functional personnel outside the organization and at all levels within Eiger.

Responsibilities include, but not limited to:

• Work closely with our vendors, internal clients and subject matter experts to plan and manage the implementation of new legal and compliance services and technologies.
• Lead the development, implementation and operation of contract management programs and policies responsive to Eiger’s legal and business needs.
• Assume responsibility for contract processes, including intake of requests from internal clients across the organization, tracking contract status, coordinating contract execution and maintaining the company’s contract management system.
• As the company grows, manage the selection, evaluation and implementation of new legal technologies such as platforms for fair market value determinations, HCP tiering, debarment checks for HPCs and Sunshine Act reporting.
• Apply a metrics-driven approach to continuously improve company’s contracting process and other legal operations and processes.
• Prepare and update contract templates and drafting playbooks.
• Represent the Legal Department internally to clients, across all levels of management.
• Draft and negotiate contracts, in collaboration with General Counsel and outside counsel, where necessary.
• Develop training materials and train employees on contracting and compliance topics including contracting processes, signature authority, financial approval authority and fair market value requirements for HCP payments.
• Assist with the development and implementation of the company’s Comprehensive Compliance Program and prepare and maintain documentation and records for Compliance and Regulatory reviews.
• Assist with the preparation and organization of records in support of the company’s Board meetings and SEC filings.
• Special projects and other ad hoc duties, as necessary.

Minimum Skills/Knowledge Required:

• Paralegal certificate and/or Bachelor’s degree from an accredited college or university.
• A minimum of ten years of direct experience in contract administration or contract operations for a U.S. headquartered public company.
• Experience in the implementation, rollout and/or release management of contract lifecycle management (CLM) software and use of DocuSign or other similar eSignature software in an in-house legal department setting.
• Able to play a leading role in selecting, configuring, testing, maintaining and explaining technology solutions.
• Experience drafting and negotiating a wide variety of contracts.
• Excellent organizational and communication skills.
• Self-starter who will continuously look for opportunities to improve processes.
• Ability to build constructive and effective relationships throughout the organization and an understanding of how to work collaboratively across business units.
• Comfort with managing competing priorities and frequent interruptions while maintaining close attention to detail, accuracy, and timeliness.

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

Eiger BioPharmaceuticals is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Eiger has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment.  If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Job Description

The Clinical Research Associate (CRA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials.

Responsibilities include, but not limited to:

• Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution
• Conducts study tracking and updates (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals
• Collaborates with the Clinical Team on the development of certain study-specific plans and/or processes
• Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Collects and reviews essential documents from investigational sites
• Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Participates in study specific tasks such as investigator identification, recruitment, collection of regulatory documents and site activation
• Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
• Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Assists with preparation of investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
• Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation
• Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed
• Assists with design and preparation of study related materials for the training of internal and external staff
• Assists with oversight of study vendors
• Participates in development of departmental processes, SOPs, and initiatives
• May represent company on external facing meetings (CROS, central labs, study training meetings etc)
• Ability and excellent in analyzing study recruitment data to help drive and identify recruitment issues

Minimum Skills/Knowledge Required:

• Bachelor's Degree preferred
• Minimum of 3 (3) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
• Experience in scientific discipline and multiple therapeutic areas preferred
• Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process
• Proficiency in MS Office including Word, Excel, and PowerPoint
• Ability to work in a team or independently as required
• Effective written and verbal communication skills
• Critically evaluates job tasks and the impact on overall trial management objectives
• Sound problem-solving capabilities
• Good judgment in triaging issues from internal and external customers
• Effectively collaborates with Clinical Trial Team members
• Outstanding organizational skills with the ability to multi-task and prioritize
• Exceptional attention to detail

Travel Required:

• Available for minimal travel (<20%) including overnight stays, when required.
• Ability to drive and have a valid driver’s license.

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

Eiger BioPharmaceuticals is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Eiger has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment.  If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication. Eiger is also developing peginterferon lambda as a therapeutic for COVID-19 and is planning to submit an emergency use authorization application to FDA based on positive results from the investigator sponsored Phase 3 TOGETHER study. All five Eiger rare disease programs have been granted FDA Breakthrough Therapy designation: lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for both congenital hyperinsulinism and post-bariatric hypoglycemia.

The Eiger management team has extensive experience in the clinical development and commercialization of a broad range of therapeutics, with special expertise in Orphan Designation drugs.  Eiger is located in Palo Alto, California.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Reports to: SVP, Corporate Affairs

Key Relationships:   

• Internal:  Senior executives and other members of management, and available to all employees and contractors.
• External:  employment candidates, consultants, recruitment agencies, recruitment channels.

Location: Palo Alto           

Date Updated: July 2022

FLSA Classification:   Exempt

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Job Description

The Director, Human Resources is responsible for implementing and managing talent-related strategies and practices to enhance the continued growth and development of the organization, its people and culture. Serve as a key thought partner to the SVP Corporate Affairs, CEO, and Executive Team; partner closely with leaders to enhance and evolve a relevant and sustainable culture. Specific responsibilities shall include formulating and implementing policies and procedures in the areas of recruiting, compensation, benefits, career development, and training. The Director, Human Resources will support the management of new programs in the areas of onboarding, performance management, and Eiger culture. They will support awareness by employees of the company’s values, behaviors, and other cultural norms. The Director, Human Resources will ensure legal compliance with all local, state and federal HR laws and regulations.

Responsibilities include, but not limited to:

• Talent Management and Development
  • Develop and enhance the reputation of Eiger as an employer of choice;
  • Attract, develop and retain top talent across the company. Develop systems to build a high-quality recruitment and development pipeline; partner with department leaders to anticipate staffing and capability requirements and to develop high performing teams;
  • Enhance and evolve a performance-based culture and competitive total rewards strategy;
  • Build and implement training and development programs to retain, inspire and build leadership;
  • Support the development of an employee value proposition and employer brand to support talent acquisition, retention, motivation and performance;
• Organization Development
  • Provide advice and counsel on organization, employee relations, and people issues;
  • Be a visible, positive and proactive change leader;
  • Recommend as required, for Executive Team approval: recruitment strategies and resources, executive search resources, engagement survey providers, performance management approaches, major compensation, benefits and HR systems changes/enhancements, company-wide learning and development programs.
  • Develop the human resource function at Eiger;
  • Ensure compliance with corporate policies and procedures as well as US and relevant global healthcare laws and regulations.
• Total Rewards
  • Develop competitive and cost-effective compensation and benefits programs consistent with the corporate culture to provide motivation, incentives and rewards for effective performers;
  • Help improve the overall operation and effectiveness of Eiger through appropriate policies, programs and procedures for effective management of the people resources of Eiger. This includes but is not limited to programs in the following areas: employee life cycle, employee relations, D/E/I, learning & development;
  • Identify and mitigate risks by ensuring compliance with all federal and state employment laws;
• Culture building
  • Assess the internal “health” of the Company and the level of engagement by its employees, and support interventions (e.g., periodic surveys, action plans, and/or other instruments)

Minimum Skills/Knowledge Required:

• A Bachelor’s degree in Human Resources, Behavioral Science, Business Administration or related field, or an equivalent combination of education and work-related experience, with 10+ years Human Resources experience preferred;
• Biotech or pharma industry and commercial stage (or other relevant company inflection point) company experience;
• Successful experience in fast-paced entrepreneurial environment;
• Ability to “think strategically, act tactically” and operate effectively on both levels;
• A hands-on team player who can operate effectively working with the company’s executive management team and has the presence to engage effectively with the Board of Directors as required;
• Persuasive communicator who can deliver concise verbal and written business updates;
• Proven track record of executing in a change-oriented environment and driving transformation;
• Experience with building and managing high performing teams;
• Natural ability to build a strong network of relationships across the company, quickly building credibility and gaining the trust and confidence of colleagues

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.

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

Eiger BioPharmaceuticals is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Eiger has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment.  If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication. Eiger is also developing peginterferon lambda as a therapeutic for COVID-19 and reported positive results from TOGETHER, a Phase 3 investigator-initiated study.

All five Eiger rare disease programs have been granted FDA Breakthrough Therapy designation: lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for both HI and PBH.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Position Overview

As one of the first colleagues to join the Eiger Medical Affairs field team, you will serve as a founding member of an expanding group that will be critical to the company’s future success. Our MSL field team will be responsible for helping to create and shape the foundation of Eiger’s Medical Affairs initiatives which will include the introduction of our company and our late-stage development programs, with a primary focus on HDV, building a key opinion leader network, developing and maintaining professional relationships with allied healthcare personnel and all external customers, and providing comprehensive medical and scientific support aligned to Eiger development and post approval initiatives. You will work collaboratively with the entire Eiger organization across all functional areas to ensure accurate and appropriate dissemination of information related to our pipeline and therapeutic areas critical to achievement of corporate objectives.

Responsibilities include, but not limited to:

• Develop and maintain scientific and medical expertise in disease states of strategic importance to the Eiger pipeline and corporate objectives;
• Identify, develop, and maintain peer-to-peer relationships with current and future Key Opinion Leaders (KOLs), Investigators, Allied Health Personnel;
• Deliver clinical presentations, product presentations, and information in response to clinicians, investigators and sites, academic settings, community and healthcare provider settings, payors;
• Report learnings and key insights from the field back into the Eiger medical team and broader organization when appropriate to support competitive awareness;
• Support Eiger clinical development activities, including site interaction when necessary, to facilitate ongoing or planned development initiatives, including patient enrollment;
• Develop and execute field regional plans in alignment with corporate strategic objectives and plans;
• Support the development, implementation, and execution of medical strategies and tactics (e.g. convention activities, advisory boards, congress symposia, regional KOL plans, and speaker programs) in close coordination with corporate objectives and plans.

Minimum Skills/Knowledge Required:

• Completed Pharm D, MD, PhD, MS in a scientific discipline preferred
• 5+ years of total pharmaceutical industry experience preferred
• 5+ years of post-professional degree practice or relevant experience (clinical practice, academic research, clinical operations, medical affairs) preferred
• Experience in literature review, analysis, and medical writing
• Hands on mentality & team-player
• Experience in Hepatology, Gastroenterology, and or rare diseases preferred
• Self-motivated, self-reliant, and able to work independently
• Knowledge of legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals
• Ability to effectively partner and maintain relationships with external stakeholders
• Ability to work cross functionally
• Excellent communication skills
• Ability to travel up to 50-60% of the time is a must

Title(s): Flexible, to be developed based on experience and fit within broader organization plan.

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, type III, well-tolerated 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]

Job Description

The Trial Master File (TMF) Specialist is responsible for the day-to-day management of the TMF, including support tasks related to the set-up, maintenance, close out of the TMF and oversight of the review and approval of TMF documents. This role has a strong focus on ensuring that document management operations are performed with adherence to standard operating procedures (SOPs) and ICH GCP/regulatory guidelines and ensuring the TMFs are always inspection ready.

Responsibilities include, but not limited to:

• Process study documentation in accordance with Standard Operating Procedures (SOPs), GCP, ICH guidelines and study specific TMF Plans.
• Support the set-up, maintenance, and closure of TMF repositories.
• Support documentation collection activities, including:-
  • Document scanning and indexing for trial using an electronic TMF
  • Document filing for trials using a paper TMF
• Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified 
• Maintain compliance with departmental quality performance and utilization targets 
• Complete administrative tasks (e.g., status reports) as requested
• Maintain compliance with company requirements (e.g., time tracking, training)
• Participates in preparation/reconciliation of TMF documentation related to audits, and shipments.
• Collaborate with functional area representatives to help ensure submission-readiness and inspection-readiness of TMFs, as needed
• Authoring and reviewing internal and external TMF-related SOPs and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes, risk-based QC processes, etc.).
• Participates in study specific training as required. 
• For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room
• Ensures the security and compliance of all documents related to active and archived projects.

Minimum Skills/Knowledge Required:

• Undergraduate degree in scientific/regulatory field or Business Management
• Minimum of 5 years demonstrable records management experience.
• Experience in a clinical trials environment highly preferred
• Familiarity with electronic TMF system preferred
• Strong verbal, written and organizational skills with a team-oriented approach.  
• Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
• Proficiency in Microsoft Office Suite and Adobe Acrobat.
• Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
• Knowledge of applicable TMF and Document Management regulations and guidelines such as MHRA and EMA.
• Working knowledge of Good Clinical Practice (GCP).

TRAVEL REQUIRED

• Minimal travel may be required (up to 10%)

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 of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]