Role Summary

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.

Key Responsibilities

• Assist project leads and/or lead 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
• 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 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 the production of Board of Directors materials, typically quarterly
• 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
• 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

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Qualifications

• Doctor 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
• Minimum three (3) years of experience (5 years preferred) managing translational science activities on an international basis 
• Working knowledge of Good Laboratory Practice principles and industry standards
• Demonstrated experience managing project teams and third-party contractors

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SKILLS/COMPETENCIES

• Capability to manage multiple projects and shifting priorities associated with an early-stage drug development company

• Prior exposure to RNA therapeutics research/development and/or cardiovascular/renal/hepatic/pulmonary/oncology disease interventions is 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

HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development.

At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.