Bill & Melinda Gates Medical Research Institute · 2 days ago

Toxicology Scientific Lead

Cambridge, MA

Full-time

Remote

Senior Level, Lead/Staff

$340K/yr - $380K/yr

8+ years exp

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Responsibilities

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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ToxicologyToxicology Board CertificationDrug Development ExperienceExperience in GLP Safety StudiesRegulatory Submission AuthoringProject RepresentationData Integration for Risk AssessmentSmall MoleculesLarge MoleculesVaccinesTechnical Writing Skills

Required

A doctoral degree (PhD, DVM, or equivalent) with a focus in toxicology, pharmacology, or related field and a minimum of 8-12 years of experience in pharmaceutical/biotech is required

Toxicology Board Certification is required

Experience as a project representative on drug development teams is required

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