Director, Preclinical Development
We are seeking a highly motivated individual to perform scientific due diligence to evaluate product opportunities as well as plan and oversee the conduct and analyses of nonclinical development activities in rare diseases. This is an exciting opportunity to grow your career by joining a small biotechnology company where you will contribute to the company strategy and achievement of key milestones.
Reporting to the Chief Scientific Officer, this role will work comfortably with academic researchers, company consultants, outsourcing CROs and other partners to implement the preclinical de-risking of projects from pharmacology through toxicology. Successful candidates will be results driven with an entrepreneurial spirit that fits with a fast-paced small company. We offer challenging and rewarding work in a small, dynamic, well-capitalized company.
- Review and evaluate primary research and published scientific data supporting in-licensing of rare disease therapeutics, including small molecule, protein or AAV based products
- Participate in development of preclinical and clinical assays and biomarkers, contribute to the design and data interpretation of preclinical activity including PK, PD, immunologic and toxicology assays
- Oversee selection of vendors and CROs for preclinical, toxicology and, as appropriate, other vendors supporting asset development
- Responsible for daily oversight of vendor/CRO activities to ensure quality science and results are delivered on time and within budget. This includes overview of protocol development and report generation, study material needs and material delivery, reports, study purchase orders and other deliverables via ongoing interactions with CROs, consultants, Legal and Finance to ensure consistency with scope of services, budgets and timelines of deliverables and payment status
- Review study data and perform statistical analyses and prepare preclinical studies reports; write nonclinical sections to support regulatory filings
- Solicit internal and external scientific expert input to integrate and coordinate activities between various functional disciplines and project activities
- Develop and integrate timelines for nonclinical activities with overall company timelines and corporate goals, in close coordination with the VP of Project and Portfolio Development and other internal and external functional areas and groups as appropriate
- Attend scientific conferences and review scientific literature to identify therapeutic opportunities that match Cydan’s strategic focus
- Meet and collaborate with academic technology transfer offices, biotechnology and pharmaceutical companies, collaborators and scientists to identify, characterize and acquire therapeutic opportunities for Cydan Development
- DVM or PhD in Biochemistry, Genetics, Pharmacology or related disciplines, with a minimum of 8 years of preclinical experience including small molecules and biologics in a biotechnology or pharmaceutical company; ideally with experience in the area of rare diseases
- Experience with development, implementation and conduct of preclinical pharmacology models, protocol writing, data generation and interpretation, and report writing to support IND and other Regulatory submissions
- Demonstrated understanding of all stages of the drug development process and ideally have worked on a product that was commercialized
- Experience with selecting and managing outsourcing to CROs and other vendors to conduct preclinical models, PK/PD studies, toxicology studies and assay development
- Familiarity with CMC process and prior experience with project teams that included drug manufacturing responsibilities
- Demonstrated judgment, intellect and experience to rapidly engage in new areas of scientific endeavor
- Proven project management and leadership skills
- Outstanding written and oral communication skills with the ability to communicate in a clear, concise, professional and well-organized manner to different audiences
- Excellent collaboration skills and the ability to work interactively with small internal and outsourced development teams as well as with multiple consultants and key opinion leaders
- Demonstrated ability to influence senior management and key functional leaders
- Experience interacting with Clinical and Regulatory groups as part of the planning and conduct of early clinical development a plus
- Excellent skills with Word, Excel, PowerPoint, Microsoft Project, and statistics analysis program(s)
About Cydan Development, Inc.
Cydan is an orphan drug accelerator that identifies and de-risks assets with therapeutic and commercial potential. The accelerator’s model evaluates programs for treating rare diseases with high unmet medical need and is aimed at creating new companies to develop those therapies. Cydan was launched in 2013 by a management team with extensive drug development and commercialization experience and with financing from leading investors NEA, Pfizer Venture Investments, Alexandria Real Estate Equities, Lundbeckfond Ventures and Bay City Capital. The accelerator is based in Cambridge, Mass. For more information, please visit www.cydanco.com.
To apply for this position, please send your resume to firstname.lastname@example.org
Please no third party solicitation