Apply📍 United States
💸 340000.0 - 380000.0 USD per year
🔍 Biopharmaceutical Development
- A doctoral degree (PhD, DVM, or equivalent) with a focus in toxicology, pharmacology, or related field
- Minimum of 8-12 years of experience in pharmaceutical/biotech
- Toxicology Board Certification is required
- Experience as a project representative on drug development teams
- Experience in design, reporting, and interpreting exploratory or GLP safety studies is required
- Prior experience authoring regulatory submissions is required
- A broad understanding of the drug discovery and development process is required
- Drug development experience in any of small molecules, large molecules, vaccines, or other modalities is required
- Ability to integrate data from multiple sources and across disciplines to form risk assessment for a drug candidate is required
- Strong interpersonal skills, and excellent verbal and technical writing skills is required
- Represent nonclinical safety with a high level of independence in multidisciplinary development teams
- Provide scientific and technical oversight for nonclinical studies conducted at contract labs in support of programs for which you have primary responsibility. This will include input on study designs, management of any issues, and effective communication with study monitor/director to ensure successful study execution and reporting.
- Develop and implement nonclinical plans that are aligned with clinical development strategies to meet regulatory requirements.
- Apply your drug development expertise to effectively communicate nonclinical information (strategies, study outcomes, issues, risks & mitigation, regulatory responses) to teams, external collaborators, and regulatory authorities, as appropriate.
- Collaborate with study monitor/director to generate high quality integrated nonclinical reports for inclusion in regulatory submissions
- Have in-depth and up to date understanding of key regulatory guidelines to support drug development
- Accountable for authoring nonclinical contributions to global regulatory submissions and responses to regulatory authorities.
- Lead resolution of any emerging nonclinical safety issues for your programs in collaboration with other functions or external collaborators, as appropriate.
- Develop hypotheses and propose mechanistic approaches to understand and mitigate issues that enable decision making
- Provide subject matter expertise to Gates MRI collaborators, as appropriate.
- Contribute to due diligence activities and other internal Gates MRI documents required for in-licensing of potential assets.
- Build effective internal and external collaborations through effective communication and relationship building
Project ManagementData AnalysisCross-functional Team LeadershipAnalytical SkillsCollaborationInterpersonal skillsVerbal communicationWritingRisk Management
Posted 3 months ago
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