Careers @ Avalanche
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- Vice President, Clinical Development / Chief Medical Officer (Menlo Park, CA)
- Research Scientist (Menlo Park, CA)
- Research Associate (Menlo Park, CA)
- Assistant Controller (Menlo Park, CA)
- Technical Services Assistant
Vice President, Clinical Development / Chief Medical Officer
The VP Clinical Development/CMO provides leadership and oversight for all medical and regulatory aspects of Avalanche’s initiatives. Will provide strategic consultation and guidance on all decisions that have significant clinical components and implications. Will design and oversee the organization’s clinical trials. Will lead a team working to secure stringent regulatory approval for new products, as well as in country registration of these products globally. Along with the CEO and other members of the Avalanche leadership team, the CMO will represent Avalanche with key stakeholders.
Specifically, the successful candidate will lead the clinical development of the company’s lead product, AVA-101 for wet age-related macular degeneration, as well as developing the clinical plans for future pipeline products. This position can be filled as either Vice President of Clinical Development or Chief Medical Officer, depending on level of experience.
The VP of Clinical Development will report to the CEO and will be a key member of the senior management team. This will include development of R&D plans and budgets, and presentation to the company’s CEO and board of directors for approval. S/he will ensure that plans are executed according to the approved timeline and budget.
- Manage ongoing clinical program, including working with functional partners on protocol amendments, ongoing filings, and statistical analysis plan. The candidate will also analyze clinical data and build presentations for the board of directors and to support corporate strategic initiatives.
- Implement clinical development and regulatory strategy clinical products, working with biostatistics, clinical operations, and regulatory functions.
- Evaluate and select contract research organizations (CROs) to support clinical development programs.
- Lead clinical development for the company’s pipeline program, including natural history studies and/or biomarker development where applicable. The candidate will lead discussions with FDA to obtain feedback and recommend the appropriate clinical endpoints to support pipeline development.
- Lead interactions with the company’s clinical advisory board.
- Collaborate with company scientists on pre-clinical development and the management of pre-clinical CROs.
Position Requirements & Experience
- 10+ years drug development experience
- Clinician with outstanding vision and technical leadership
- Board certified M.D., with specialization and/or industry experience in ophthalmology.
- Experience in retina sub-specialty preferred.
- Experience designing and overseeing one or more clinical development programs in biotechnology or pharmaceutical product development.
- Excellent, respectful and persuasive communication skills
- Experience managing direct reports, CROs, and project teams.
- Extensive experience providing clinical training
- Experience in the development, conduct and analysis of clinical trials both within and outside the U.S.
- Strong scientific and clinical background, with the ability to provide scientific thought leadership for the company and clinical advisory board.
- Self-starter with ability to learn new disciplines.
Principal Scientist/Senior. Scientist or Director, Preclinical Development
The Director of Preclinical Development will lead the preclinical development activities (pharmacology and toxicology) for the company’s lead product, AVA-101 for wet age-related macular degeneration, as well as developing and executing pre-clinical development plans for future pipeline products in ophthalmology.
The Director of Preclinical Development will report to the VP of Research. S/he will manage a team of preclinical scientists and be responsible for running pre-clinical development across multiple programs. This will include regular presentations to Avalanche’s scientific leadership and board of scientific advisors.
- Design and manage pre-clinical ophthalmic studies (GLP and non-GLP) for inclusion in IND and BLA submissions, including pharmacology, toxicology, and biodistribution studies
- Select and manage contract research organizations (CROs) to support pre-clinical development programs
- Work closely with other functional areas and colleagues to insure that all studies are performed in a quality, timely and scientific manner
- Write and edit pre-clinical study reports
- Write pre-clinical sections for IND and BLA submissions
- Manage up to 4 pre-clinical scientist direct reports
- Work with external collaborators on retinal disease models
- Participate in discussions with FDA to obtain feedback on pre-clinical development programs
- Collaborate with company scientists on clinical development plans
- Ensure compliance with GCP, GMP, and regulatory guidelines
- Will develop and oversee non-clinical safety and toxicology drug development plans with estimated costs, timing, and risk assessment/management
- Identify and resolve nonclinical study operational issues and maintain project timelines
- Develop safety-related issue mitigation or resolution plans and coordinate execution of the experimental plan as required
- Interact with CRO's to coordinate, design and monitor GLP and non-GLP toxicology and safety pharmacology studies
- Critically review and edit CRO toxicology study reports, analyze and interpret data (e.g., toxicology, DMPK, analytical) and coordinate report finalization
- Coordinate cross-departmental activities necessary for the effective conduct of safety assessment studies
- Communicate toxicology study findings, including relevance and interpretation, to project teams
- Prepare and edit non-clinical documents for regulatory submission (e.g. INDs, IB''s, and regulatory briefing documents)
- May interact with regulatory agencies on nonclinical matters
- Maintains a current understanding of toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects
- Maintains a current understanding of regulatory requirements and guidances
Position Requirements & Experience:
- Ph.D. in Biological sciences, Toxicology, Pharmacology, DVM or M.D required; DABT certification desirable but not required
- 8-10 years drug development experience, with minimum 5 years working in industrial pharmaceutical toxicology/safety assessment drug development
- Experience with preclinical models for ophthalmology/retina
- Good understanding of analytical/bioanalytical measurement techniques and methodology
- Ability to synthesize and interpret diverse, multidisciplinary data sets
- Experience participating on drug development teams and IND submissions
- Experience in designing, monitoring and interpreting non-clinical safety studies
- Strong knowledge of pre-clinical drug development and FDA and ICH guidance documents including GLP regulations for non-clinical studies with biologics is essential
- Experience with gene therapy vectors preferred
- Excellent written and oral communication skills
- Experience managing direct reports, CROs, and project teams
- Self-starter with ability to learn new disciplines
- Able to demonstrate flexibility in a dynamic, entrepreneurial setting
This is a position for a highly innovative, passionate, and energetic Scientist to develop adeno-associated viral vector technologies for ophthalmic disease targets in an industry setting. The candidate should be extremely motivated to scientifically contribute to the dynamic research program at Avalanche Biotechnologies as well as assist other cross-functional teams when needed.
- Pursue work with the goal of carrying out novel research of the highest quality to understand, improve, and advance Avalanche Biotech’s product pipeline.
- Independently design and execute experiments following appropriate laboratory procedures and produce competent and reproducible results to a high technical standard.
- Appropriately analyze data, interpret results, and maintain accurate records with minimum supervision
- Participate in the development of assays for the characterization of vector products
POSITION REQUIREMENTS AND EXPERIENCE:
- The candidate should possess a Ph.D. in the Biomedical Sciences. The candidate should also have been productive and successful during his/her post-doctoral training
- A broad knowledge base in molecular biology, biochemistry, immunology, and gene therapy. Background in the area of retinal diseases is desired and understanding of AAV biology is favorable.
- Have at least three first-author papers in peer-reviewed journals.
- Expertise in a variety of laboratory techniques such as recombinant DNA technology, including qPCR, vectorology, DNA/RNA isolation and analysis; sterile tissue culture techniques; biochemical techniques including, Western Blot, flow cytometry, immunofluorescence, and ELISA.
- Experience with ocular in vivo animal models is preferred and know-how with the baculovirus expression system is a plus.
- Also required:
- Qualified candidates should be detail oriented and have good time management skills
- Must be proactive, co-operative, and willing to work in a small team environment
- Have excellent verbal and written communication skills
- Be proficient with MS Office and other commonly used software
Performs research and / or product development aimed at developing adeno-associated vector products for pre-clinical or clinical applications. In collaboration with process development and assay development teams, assists in the production of adeno-associated vector preparations through various processes as well as participate in the development of assays for the characterization of vector products.
- Executing assigned tasks following appropriate laboratory/technical procedures under minimal supervision.
- Assisting with the investigation, creation and development of methods, experiments and / or technologies
- Making detailed observations and analyzes data to provide an interpretation of results.
- Preparing technical reports, summaries, protocols, and / or quantitative analyses.
- Producing competent, reproducible results to a high technical standard
- Maintaining accurate and well-organized laboratory records, worksheets and notebooks.
Position Requirements & Experience:
- BS/BA or MS with 3-5 years relevant experience in bio-pharma R&D, process development or assay development group
- Experience with a variety of laboratory techniques including, sterile tissue culture techniques, DNA/RNA isolation and analysis, PCR/QPCR, ELISAs, SDS/PAGE, Western blot etc. Experience with the baculovirus system of expression or other suspension cell culture systems a plus. Experience with preparative chromatography techniques highly preferred.
- Also required:
- Must be detail-oriented with good organization and time management skills
- Excellent verbal and written communication skills
- Willingness to take on multiple responsibilities and work in small team environment
- Proficiency with MS Office and usual laboratory software (Softmax Pro, etc.)
The Assistant Controller is responsible for the general accounting activities of the company in accordance with GAAP including month-end-close, financial reporting and ad hoc projects, as needed. He/she will also be responsible for managing accounts payable, cash management/disbursement, payroll, stock maintenance and other HR functions. He/she will develop, implement and maintain Company and Accounting policies and procedures. This position reports to the CFO.
Essential Duties and Responsibilities:
- Maintain the General Ledger including sub-ledgers and schedules
- Perform monthly closing process including posting journal entries and account reconciliations and project allocations
- Process Accounts Payable, Payroll and 401K transmittal
- Maintain the cash records for the company and reconcile all cash accounts to bank statement monthly
- Responsible for monthly financial reporting including consolidation of a foreign sub and budget vs. actual analysis. Ensure timely and accurate financial reports to the management team
- Assist with annual financial external audits and external reporting requirements
- Prepare tax schedules and other requested items to assist outside firm in preparing federal and state income tax filings
- Ensure timely reporting of all taxes and regulatory filings with the appropriate local, state and federal authorities
- Assist with the annual budgeting process and forecasting
- Assist with the development and implementation of internal controls and preparation of SOX 404 implementation
- 5+ years of relevant work experience required
- CPA desired
- Life science / biotech experience desired
- Proven management and supervisory skills
- Strong financial reporting and strong accounting skills and knowledge
- Strong communication skills
- Ability to multi-task and work in a fast-paced environment under tight deadline
Technical Services Assistant
The Technical Services Assistant is responsible for carrying out routine tasks, all of which can include: receiving (packages), point of use replenishment (inventory), chemical repacking, cylinder delivery and pickup, managing dry ice and liquid nitrogen dispensing, waste disposal and glass washing. Must be cognizant of and adhere to Standard Operating Procedures and regulatory requirements, as applicable.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Support technical services (animal cage and glass washing, autoclaving Biohazard waste)
- Support shipping and receiving
- Accounting by conducting purchase order reconciliation
- Responsible for handling hazardous material and preparing shipping documentation and packaging requirements.
- Maintain and check eye wash showers/stations
- Assist with other technical departments, Facilities, IT, etc.
- Other duties as assigned
EDUCATION / EXPERIENCE / QUALIFICATIONS:
- Minimum of a high school diploma
- 1-2 years of college with laboratory experience
- Previous experience working in a GMP facility a plus
- Spill containment training, IATA, DOT
- Excellent written and verbal communication skills are essential, excellent people skills, and team player.
- Basic computer skills including Microsoft Office with proficiency in Word and Excel
- Ability to prioritize tasks and meet deadlines
Knowledge, skills, and abilities:
· Strong communication skills
· Excellent customer service skills, written and verbal; display a professional can-do attitude
· Perform duties with the highest regard for safety and quality
· Ability to understand and follow site protocols, policies and procedures
· Must be flexible, forward- thinking, motivated, and have the ability to act independently
· Must be able to lift 50 lbs minimum
· Ability to prioritize tasks and meet deadlines
· Knowledge of vendor products and services
· Problem-solving skills
PHYSICAL DEMANDS: On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file/fax/or copy documents, and write or use a keyboard to communicate through written means. Walking and lifting up to 50 pounds may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.