Senior Scientist II or Principal Scientist, Translational

Reporting to the VP of Translational Science, the Translational Scientist plans, designs, coordinates and oversees implementation and management of preclinical studies on the critical path for development programs, performs data analysis, interpretation, and presentation of results and may contribute to clinical study synopses/protocols, Investigator Brochures, regulatory communications, preclinical study reports, and data collection systems.

• Assist project leads and/or leads planning, design, communication, coordination, and oversight of planned preclinical studies internally or with CROs to support portfolio programs, driving these studies to implementation and completion on a timely basis
• Leverage Haya platform functional expertise and learnings (Functional Genomics, Data Science) to interrogate and maximize value from in vitro and in vivo pharmacology studies
• Implement/lead, conduct, and manage in vivo pharmacology studies, potentially in Charles River Labs (CRL) vivarium at Lilly Gateway Labs site in San Diego, including coordination of internal staff scientists and CRL technicians
• Design and review study protocols and reports, including IND-enabling and GLP study-specific documentation
• Assist in review of clinical study summary reports and supporting documentation for Modules 2 and 4 of INDs and NDAs/CTDs, as needed
• Assist in the assessment of CROs, including leading and coordinating Request For Quotation processes
• Help develop and manage translational budgets and report variances on a timely basis
• Establish and manage project timelines and critical path activities using Tiger Light project management software
• Contribute to production of Board of Director meeting materials, typically quaterly
• Help develop, communicate and implement Company standards and appropriate policies and procedures
• Act as primary project contact to external third parties, as assigned
• Work with clinical and other internal departments to understand needs, identify and resolve challenges within a matrix management setting
• Establish and nurture positive relations with preclinical vendors and team (internal/external) personnel, including consultants and fractional staff
• Manage direct reports, as assigned
• Perform other related duties as assigned or directed
• Travel may be required up to 20% of the time

• Doctorate of Philosophy Degree or equivalent in health sciences;
  Master’s degree considered
• Previous experience working in a project team environment in industry (biotech or pharma) with demonstrated success in an integral role supporting nomination of a development candidate molecule and conduct of IND-enabling research activities
• Experience writing and reviewing nonclinical IND regulatory documentation preferred
• Minimum three (3) years experience (5 years preferred) managing translational science activities on an international basis; for Senior Scientist II/Principal Scientist, >10 year experience preferred
• Working knowledge of Good Laboratory Practice principles and industry standards
• Demonstrated experience managing project teams and third party contractors

• Capability to manage multiple projects and shifting priorities associated with an early stage drug development company
• Demonstrated strong cross-functional and teaming capabilities
• Prior exposure to RNA therapeutics research/development and/or cardiovascular/renal/hepatic/pulmonary/oncology disease interventions are desirable
• Demonstrated ability to thrive in a multicultural environment, with flexibility to collaborate effectively across various time zones and international teams, supported by high emotional intelligence and self‑awareness
• Tools and concepts of project management (e.g. management of resources, planning and budgeting, risk management, contingency planning, analysis and reporting, and written and verbal communication)
• Proficient in the use of MS Word, Excel, PowerPoint and Project