Senior Managing Scientist

ToxStrategies, a BlueRidge Life Sciences Company

. Address scientific, regulatory, and business challenges associated with pharmaceutical/biopharmaceutical product development .

Posted 10/16/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in toxicology and pharmacology with extensive experience in regulatory submissions and interactions with global regulatory authorities. Proven ability to manage nonclinical safety assessments and lead multidisciplinary teams in the biopharmaceutical industry.

Highest-signal resume keywords

Ph.D. In Toxicology15+ Years Of Biopharmaceutical ExperienceRegulatory Document WritingProject Management ExperienceDABT Certification

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Data InterpretationToxicology Study DesignNonclinical Safety AssessmentRegulatory Submission DocumentsGap AnalysisSafety Data InterpretationPharmacology Sections WritingExpert Opinion ReportsBusiness Development ActivitiesMultidisciplinary Team Collaboration

Soft Skills

Written Communication SkillsVerbal Communication SkillsIndependent WorkTeam CollaborationPresentation Skills

Certifications & Qualifications

DABT Certification

Industry Keywords

Pharmaceutical DevelopmentBiopharmaceutical DevelopmentRegulatory Agency GuidanceICH GuidelinesFDA InteractionContract Research OrganizationsPre-INDIND/CTANDA/BLAToxicology Meetings

About the role

Key responsibilities & impact

Address scientific, regulatory, and business challenges associated with pharmaceutical/biopharmaceutical product development
Oversee study placement, design, data interpretation, and monitoring of toxicology studies
Interpret safety, TK/PK, and PK/PD data
Serve as the toxicology representative on project teams
Participate in meetings with global regulatory authorities
Write or oversee pharmacology/toxicology sections of regulatory submission documents, including pre-IND, IND/CTA, and NDA/BLA documents
Write or oversee expert opinion reports, waiver requests, presentations, and proposals
Participate in due diligence meetings for in- and out-licensing
Attend and present at toxicology meetings, serve on professional/scientific committees, and publish papers or book chapters
Conduct business development activities to attract and develop new projects and clients
Work alongside toxicologists, epidemiologists, engineers, and biostatisticians
Travel may be required, up to approximately 20%

Requirements

What you’ll need

15+ years of biopharmaceutical/pharmaceutical experience in consulting and/or industry, government (e.g., FDA), or Contract Research Organizations (CROs)
Ph.D. degree in toxicology, pharmacology, or related sciences
DABT certification desired but not required
Prior pharmaceutical consulting and/or pharmaceutical industry and/or government experience required (minimum 15+ years)
Comprehensive understanding of ICH and regulatory agency guidance documents for nonclinical drug development
Experience working with drug development teams and overseeing nonclinical safety assessment programs through all development phases (e.g., pre-IND to marketing)
Experience performing nonclinical gap analyses for drug development programs
Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs), and interacting with regulatory agencies
Experience managing and resolving project-related and toxicology and/or clinical-hold issues
Project management experience, including the ability to manage multiple assignments and balance complex, high-priority programs and stringent timelines
Demonstrated written and verbal communication skills
Ability to work independently or in multidisciplinary teams
Membership and active involvement in scientific/toxicology professional organizations, including recent presentations and/or publications

Benefits

Comp & perks

Opportunities for professional development and leadership
Competitive compensation and benefits