Summary Description

This role is an integral part of the finance organization and the company at large. The Director FP&A is responsible for managing the company’s strategic long-range financial plan, rolling forecast, annual budgets, and analysis of financial results. This person is also responsible for preparing and presenting financial information, including variance analysis, scenario and portfolio planning and company metrics, to the senior management team/board, as applicable. This is a key position in the finance organization and will provide many opportunities for growth and development with frequent interactions with executive management and a key role in preparing analyses that will support decision-making across the business. The position reports to the Vice President of Finance and will work closely with the CFO.

Essential Duties & Responsibilities

  • Drive the annual budget process
  • Manage the quarterly update process for the rolling forecast
  • Prepare and distribute budget vs. actual variance analysis and related reporting to department heads
  • Meet with department heads to ensure a thorough understanding of their operating results and related variances from budget
  • Support the commercial operations group in development of long-term revenue models
  • Assist with consensus estimates, stock price performance and other ad hoc research projects to support Investor Relations
  • Prepare various financial models and scenarios to provide support to various strategic discussions by executive management 
  • Provide financial and analytical support on existing portfolio for business development and scenario analysis
  • Build and maintain the Company’s strategic long-range financial model
  • Preparation and presentation of board materials in relation to any or all the above
  • Develop and manage monthly executive summary and metrics reporting
  • Special projects, as needed

Position Requirements

  • Advanced/expert knowledge of excel is required
  • Excellent analytical & modelling skills
  • Strong communication skills, including ability to interface with all levels and internationally
  • Knowledge of project and department budgeting
  • Ability to meet deadlines and manage conflicting priorities
  • Strong financial planning skills with ability to understand the details and identify the impact on the “big picture”
  • Proven ability to multi-task, and to adapt and proactively respond to a changing environment
  • Ability to plan and execute complex tasks and to solve problems independently
  • Strong financial planning skills with ability to understand the details and identify the impact on the “big picture”
  • Highest level of professional and ethical performance standards
  • Experience as an effective leader, people manager and a team builder
  • Energetic, dedicated, and enthusiastic team player with high degree of initiative

Qualification Requirements

  • 5-10 years of related experience, including within life sciences
  • Banking experience or similar experience building complex excel models
  • BA/BS in Finance, Management Science or Life Sciences is required
  • MBA desirable
  • Experience with Anaplan or other planning software desirable

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:

Careers@eigerbio.com

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:

Careers@eigerbio.com

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:

Careers@eigerbio.com

Position Overview

The Vice President, Investor Relations & Corporate Communications is an important, newly created position at Eiger.  Reporting to the CFO, this individual will be responsible for strategic and operational leadership of all IR and corporate communications activities.  This position will work with the senior leadership team to define and strengthen our IR plan, external communications strategy across multiple platforms, elevate Eiger’s external profile, and expand the company’s investor base.  The VP, Investor Relations & Corporate Communications will be responsible for external communications, including social media, press releases, corporate presentations, and investor call scripts.

Essential Duties and Responsibilities

  • Assess current investor relations plan and propose and drive new strategies and tactics to expand Eiger’s investor base and elevate Eiger’s external profile
  • Own external communications, including website, social media, corporate overview presentations, investor call materials (script, Q&A, messaging)
  • Conduct outreach to sell-side and buy-side analysts, investors, and media as needed
  • Build relationships with analysts, investors, and appropriate media contacts
  • Assess current investor base and identify new investors to target to convert to Eiger stockholders
  • Work with FP&A to manage/update consensus estimates and understand drivers of analysts’ financial models
  • Work with other functions internally to develop integrated communications plan, including scientific publications and KOL events
  • Track progress against IR and media plan; present updates to board as needed
  • Track and analyze competitive landscape across Eiger’s portfolio
  • Analyze impact of biopharmaceutical industry news and competitor news on Eiger’s operations and portfolio
  • Lead evaluation to identify IR and/or PR firms to provide additional support as needed
  • Manage participation and 1x1 meetings during investor/banking conferences
  • Work closely with CEO and senior leadership team and other internal functions to manage communications for ad hoc issues that are tailored to specific platforms/audiences but with clear, consistent underlying messages
  • Contribute to Eiger’s culture of compliance with IR function and across company, working with Legal, Finance, and Regulatory
  • Other responsibilities may be assigned

Position Requirements

  • Bachelor’s Degree required; MBA or higher scientific degree (e.g. MS, PhD) a plus
  • Relevant IR experience – 10+ years of experience in IR/Corporate Communications leadership position
  • Excellent communication skills; track-record of producing high-quality written content and presentations – applicants may be asked to submit portfolio of various written content or presentations
  • Ability to understand, assimilate, and communicate complex scientific and clinical information
  • Previous experience in rare disease or hepatology field a plus
  • Strong executive presence – able to communicate confidently and credibly with Eiger’s senior leadership team, board of directors, and external audiences including investors and media
  • Demonstrated expertise in communicating and building relationships with analysts and portfolio managers
  • Previous demonstrated ability to thrive in a fast-paced, small organization with multiple competing priorities and upcoming transformational milestones
  • Financial public relations and investment analysis experience, with an in-depth understanding of the dynamics of biopharmaceutical industry

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:

Careers@eigerbio.com