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Company | Enanta Pharmaceuticals |
Address | Watertown, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-10-10 |
Posted at | 1 year ago |
Enanta Pharmaceuticals is using our robust chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for viral infections and liver diseases. With R&D efforts focused on respiratory syncytial virus (RSV), hepatitis B virus (HBV), SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV), Enanta continues to grow as we progress our pipeline.
- Contribute to various regulatory documents and ensure regulatory compliance.
- Oversee preclinical toxicology studies at external contract research organizations (CRO), including:
- Evaluate individual and programmatic study data (anatomic pathology, clinical pathology, in-life parameters, etc.) as to the potential toxicity of experimental compounds in different animal species and prepare verbal and written summaries for internal discussions.
- Ensure appropriate project management and oversight with multiple CROs.
- Facilitate study initiation by executing appropriate processes for contract implementation, test article procurement, protocol development, and timeline commitments.
- Monitor studies for appropriate conduct, accuracy and timely completion; audit raw data for accuracy; and review draft reports for completion.
- Build strong collaborative relationships with research and development teams to meet project, departmental, and company goals.
- Work with the Toxicology team to develop optimal strategies to address specific safety issues and partner with project teams to select and advance Development compounds.
- Serve as a key resource, providing scientific knowledge and expertise to cross-functional project teams.
- Anticipate study problems and opportunities and raise issues with suggested resolutions to supervisor.
- Technical writing proficiency preferred
- Direct experience with Good Laboratory Practices (CFR 21 Part 58) preferred
- In vivo study director experience preferred
- Solid foundation in animal and/or biomedical sciences, including toxicology, pathology, and physiology with proficient knowledge of developmental and reproductive biology
- DVM/PhD or DVM
- Able to work in a strong collaborative environment
- Strong commitment to quality and accountability
- Data-driven decision-making
- PhD in Toxicology, Pathology, or related health science field; Board Certification in Toxicology (ABT) strongly preferred, or
- Education
- Excellent written and oral communication skills
- Effective problem-solving skills and judgement
- Strong organizational and project management skills
- Collaboration & Teamwork: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving.
- Communication/Presentation Skills: Excellent ability to convey both written and verbal information effectively and efficiently and present information to all levels of audiences.
- Leadership: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations.
- Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
- Strategic Thinking: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.
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