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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Nonclinical Drug Safety and Drug Development, with a strong focus on study design, regulatory submissions, and cross-functional collaboration. Proficient in integrating AI/ML tools to enhance drug discovery processes and project management.
Highest-signal resume keywords
Drug DevelopmentDrug Discovery ResearchProject ManagementStudy DesignMatrix Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Nonclinical StrategiesRegulatory SubmissionsBiological SciencesPharmaceutical SciencesClinical Development
Soft Skills
Cross-Functional CollaborationExcellent CommunicationIndependent Project ExecutionTeam Interaction ManagementReprioritization
Tools & Technologies
AI/ML ToolsGenerative AI
Industry Keywords
Drug DiscoveryClinical DevelopmentRegulatory AgencyStudy DesignMultidisciplinary Teamwork
About the role
Key responsibilities & impact- Support the technical, operational, and scientific aspects of drug development in Nonclinical Drug Safety
- Partner with Discovery Program Leaders, Compound Leaders, and Therapeutic Area Leaders
- Ensure scientifically rigorous study designs are developed, requested, and communicated
- Interface with Operations–Project Planning and impacted laboratory/operational areas regarding study design or timeline changes
- Coordinate with Central Pharmacy and other DPTM areas on drug supply, material allocation, formulation, and stability
- Align study and submission timelines with NDS and program stakeholders
- Assist with regulatory packages including PSURs/DSURs, IBs, INDs/IMPDs, and WMAs
- Track regulatory agency comments and resolutions
- Escalate program issues to NDS management
- Standardize and streamline drug development procedures within NDS and across DPTM
- Train and support Discovery Program Leaders and Compound Leaders
- Lead independent nonclinical drug discovery and development projects
- Integrate AI/ML and generative AI tools to streamline program support, synthesize nonclinical data, mine insights, generate hypotheses, and inform project decisions
Requirements
What you’ll need- BA/BS or equivalent in biological sciences, chemical or pharmaceutical/medical/regulatory sciences required
- At least 5 years of experience in NDS or similar functions
- Proven knowledge of drug discovery and development processes and guidelines, particularly nonclinical strategies
- Familiarity with the range of nonclinical studies required to support drug discovery, clinical development, and marketing approval
- Demonstrated cross-functional collaboration skills and ability to succeed in a matrixed environment
- Excellent communication skills, including facilitating meetings, presenting, and managing team interactions
- Ability to execute independent projects and balance activities for multiple projects simultaneously
- Ability to take on urgent assignments independently, reprioritize work, and coordinate with other areas
- Required skills: Drug Development, Drug Discovery Research, Matrix Management, Multidisciplinary Teamwork, Project Management, Project Planning, Strategic Planning, Study Design
- No visa sponsorship
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangements
