The Principal Scientist, Toxicology will provide scientific and operational leadership for non-clinical toxicology activities supporting drug discovery and development programs. This role is responsible for the strategic design, execution, oversight, interpretation, and reporting of outsourced GLP and non-GLP toxicology and related nonclinical studies to support global regulatory submissions.
Essential Responsibilities:Study Monitoring & Nonclinical Oversight- Serve as Study Monitor with responsibility for oversight of all phases of outsourced GLP and non-GLP studies, including study enabling activities, study setup, protocol development, on-site monitoring of study conduct at CRO sites, and review of data and reports.
- Provide scientific guidance, feedback, and directives to Study Directors and non-clinical sub-team members, including coordination of:
- CMC/Formulation planning to support study requirements, including manufacture, release testing, and shipping
- Sample shipping and logistics in collaboration with Operations
- Study timeline development in partnership with Project Management
- Maintain GLP compliance for all aspects of GLP studies and ensure adherence to internal SOPs and regulatory expectations.
- Archive final study reports and associated data in IQVIA in accordance with regulatory and company requirements.
- Conduct technical audits and coordinate QA compliance audits of CROs to ensure data integrity and regulatory readiness.
Project Leadership & Cross-Functional Collaboration- Collaborate closely with multidisciplinary drug discovery and development teams including CMC, Clinical, Regulatory Affairs, Pharmacokinetics, Bioanalytical, and Project Management.
- Interface with drug safety team leads and represent toxicology as the primary point of accountability for the design, execution, data interpretation, and reporting of in vivo toxicokinetic (TK), tolerability, and investigative studies.
- As appropriate and commensurate with experience, serve as the Nonclinical Project Lead on Project Core Teams.
Scientific & Regulatory Contributions- Develop protocols, procedures, data templates, and report templates for non-GLP studies and ensure submission-ready study reports to support advancement of drug candidates.
- Contribute to and/or author nonclinical sections of global regulatory filings, including Pharmacology, PK, and Toxicology sections for INDs, NDAs, Marketing Applications, and regulatory briefing documents.
- Respond to questions from global regulatory agencies to support clinical trial applications and regulatory submissions.
CRO & Vendor Management- Oversee and manage CRO performance, timelines, budgets, and deliverables to ensure high-quality outcomes.
- Support global programs requiring flexibility in work hours, including evenings and weekends, to meet critical timelines and milestones.
Financial & Strategic Planning- Contribute to budget estimates for nonclinical studies and ensure actual costs remain aligned with projected budgets on a quarterly and annual basis.
- Support portfolio and project planning through proactive identification of risks, mitigation strategies, and resource needs.
Essential Physical Characteristics:Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.
On-Site Protocol:Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
Qualifications:
- PhD in Toxicology, Pharmacology, or a related life science discipline (DVM or equivalent may be considered)
- 8+ years of relevant experience in pharmaceutical or biotechnology drug development, with demonstrated leadership in nonclinical toxicology
- Extensive experience overseeing outsourced GLP and non-GLP toxicology studies
- Direct experience supporting IND and later-stage regulatory submissions
- Strong knowledge of global nonclinical regulatory requirements (FDA, EMA, ICH)
- Proven ability to lead cross-functional teams and manage external vendors
- Excellent scientific writing, communication, and presentation skills
- Collaborative leadership style with sound scientific judgment and accountability
Required Key Attributes:- Must be able to work independently as well in cross-functional team settings with supervision as needed.
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
- Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
- Strong problem-solving skills and a proactive attitude towards exploring new approaches.
- Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
Compensation:- This is a full-time position, Monday-Friday, occasional overtime.
- Pay is commensurate with experience.
- Equity-based compensation
- Performance-based bonuses
- 401(k) with Company Match
- Medical, Dental, Vision
- Flexible Spending Account
- Life Insurance
- Employee Assistance Program
- Employee Discounts
- Gym Membership
- Paid Vacation
- Paid Holidays
- Paid Sick, Jury Duty, Bereavement
Work Authorization:- United States (Required)
- Background Check
