Eiger Biopharmaceuticals is a clinical-stage biopharmaceutical company committed to developing and commercializing novel products for the treatment of Orphan diseases. Eiger has built a diverse, late-stage portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, a novel biology for treatment has been identified, and for which an effective therapy is urgently needed. 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.
The Vice President of Regulatory Affairs will manage and, as needed, build a premier regulatory group that provides strategic leadership for regulatory strategy, regulatory operations, agency interactions, and submissions, both domestically and globally. The candidate will work cross-functionally to develop and implement regulatory strategy and provide leadership of all regulatory submissions including briefing documents, INDs, NDAs, BLAs and supplemental applications. Additional responsibilities include: regulatory compliance, regulatory advice and counseling, review of external communications, and assessing the landscape to assess regulatory risks and pathways for expedited development timelines. An integral part of this role is fostering strong relationships with FDA and international regulatory authorities.
The successful candidate will have the following key areas of focus:
- An understanding of how to leverage the resources of an emerging biopharma company to successfully manage multiple priorities across a diverse therapeutic pipeline.
- Provide regulatory guidance that expedites the review process for drugs with an orphan or ultra-orphan designation.
- Convert strategy to regulatory execution. Provide leadership of internal resources and external partners to ensure successful regulatory execution.
- In alignment with Eiger’s global regulatory strategies, develops and leads the implementation of regulatory strategies throughout all stages of clinical and commercial development.
- Design regulatory strategies and build a stage-appropriate team to support business decisions, product applications and claims, from development through product lifecycle management.
- Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Company products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
- Facilitate best strategy for clearance/approval of products in rest-of-world regions
- Act as primary strategic contact with the FDA and other regulatory agencies to enable execution of company regulatory goals.
- Develop and design appropriate regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into future direction.
- Support Pharmacovigilance and Safety functions
- Provide guidance to business development regarding critical evaluation of potential product opportunities.
- Develop and plan regulatory strategies that yield differentiated product label.
- Oversee all required ongoing regulatory submissions.
- Provide regulatory review and approval of external communications in support of clinical trials and marketing or approved products.
Bachelor of Science Degree; PharmD, PhD or MD degree preferred.
The ideal candidate will possess at least 15 years of experience leading Regulatory Affairs within the pharmaceutical industry with 7 years of specific leadership and management experience. Experience in the review and approval of small and/or large molecules for orphan and/or ultra-orphan diseases is advantageous. Building and running Regulatory Affairs within an emerging biopharma company, while not required, is also an advantage. An advanced degree is ideal.
Strong leadership competencies and strategic business perspectives are required to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and submission activities.
Other Skills and Abilities:
The Vice President, Regulatory Affairs will have a strong understanding of the US and global pharmaceutical drug development and regulatory environment, particularly within the FDA and EMA. Ideally, this executive will have a history of active involvement with highly collaborative partnerships, and in/out-licensing business opportunities. The VP, Regulatory Affairs will also possess the ability to assimilate and interpret trends in the US healthcare policy environment that directly affect business decisions in the pharmaceutical/biotech industry.
Candidate must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. This person will demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. Candidate will be entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
Please send resume to Matthew Bys at email@example.com.
Reports To: Chief Business Officer
Job Location: Palo Alto, California
Position Type: Full-time, Exempt
This is a Senior Management position reporting to the Chief Business Officer. The candidate will be a member of the Executive Leadership team of Eiger Pharmaceuticals and have oversight of Pharmaceutical and Technical Operations.
- This individual will report to the Chief Business Officer and will be responsible for leading all facets of chemical manufacturing and pharmaceutical development activities for Eiger Pharmaceuticals’ investigational and commercial products
- Will be responsible for building and managing analytical, formulation, preformulation and manufacturing operations
- Define and execute CMC regulatory strategy with input from regulatory and compliance functions
- Develop successful CMC relationships with corporate alliance partners
- Prepare and maintain department budgets
- Participate in defining strategic goals and objectives for company
- Evaluate and provide recommendations for in-licensing and/or acquisition of product assets
- Provide leadership, guidance, development and mentoring of internal and external parties composed of CMC, preclinical, clinical, regulatory, project management and business development members
- Ph.D in chemistry/chemical engineering or related discipline
- 15 years in the Pharmaceutical industry
- Must be able to work effectively with Clinical Operations, Regulatory Affairs, Quality Assurance and Project Management to meet aggressive deadlines
- Excellent leadership capabilities, exceptional communication skills, ability to keep calm and focused under pressure, tactful, diplomatic, creative, scientific interest and ability
- Strong organizational abilities
- Motivated, self directed
Preferred Certifications/Licensures: None
Travel Requirements: Low, < 15% (domestic and international)
Please send resume to: firstname.lastname@example.org
Eiger offers an excellent compensation package including competitive compensation and benefits package. Regular full-time employees are eligible for the following benefits:
Eiger’s group health plans includes medical, prescription, dental and vision insurance. The plan offers HMO and PPO options that provides comprehensive medical coverage.
Life Insurance/AD&D and Voluntary Supplemental Life Insurance
Employees are covered by group life insurance through the company and also for accidental death and dismemberment coverage. Employees are also offered the opportunity to purchase voluntary life insurance at competitive rates for themselves and their family members.
Short-Term Disability and Long-term Disability
The Company provides a policy that may replace up to 66.67% of your salary, up to a maximum benefit of $2,308 per week, for qualifying disabilities, for up to a maximum benefit of 180 days.
The Company provides a policy that may replace up to 66.67% of your salary, up to a maximum benefit of $10,000 per month, for qualifying disabilities. A waiting period of 180 days will apply.
Employee Assistance Program (EAP)
The EAP is available at no cost, even if you don’t enroll in Eiger group benefits. You and your family members may access free, confidential counseling and referral services. This program provides 24-hour confidential assistance with personal, family and work-related concerns – plus online resources.
Flexible Spending Account (FSA) & Dependent Care Spending Account
FSAs help you pay for eligible out-of-pocket health care and dependent day care expenses on a pre-tax basis. You determine your projected expenses for the Plan Year and then elect to set aside a portion of each paycheck into your FSA. For the 2012-2013 Plan Year you may contribute from $200 to $5,000 to each FSA
Pre-Tax Commuter Benefits:
The commuter benefit plan allows you to set aside pre-tax dollars to pay for eligible commuting costs, such as expenses for parking, public transit and alternative forms of transportation. Passes can be delivered right to your home, or you can simply submit monthly receipts for reimbursement
Eiger provides its employees with ten paid holidays and two floating holidays per year.
During the first three years of continuous, full-time employment, Eiger employees accrue five hours of vacation per pay period, up to a maximum of 120 hours per year. After three years of service, employees earn 160 hours per year. The maximum amount of vacation that may be accrued is 160 hours.
*The information contained herein is for informational purposes only and subject to change without notice. This document is just an overview.
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Or mail to:
Eiger BioPharmaceuticals, Inc.
350 Cambridge Ave, Suite 350
Palo Alto, CA 94306