Full-Time Senior Consultant - Nonclinical Product Development
Sia is hiring a remote Full-Time Senior Consultant - Nonclinical Product Development. The career level for this job opening is Senior Manager and is accepting Elkridge, MD based applicants remotely. Read complete job description before applying.
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Product Development
The Product Development Group provides technical support and scientific expertise to advance client programs, guiding them from research to regulatory submissions.
Nonclinical Product Development Services:
- Strategic advisory and operational support for nonclinical product development, toxicology, and due diligence.
- Support for a broad range of products (drugs, biologics, medical devices, diagnostics).
- Ensuring product safety and efficacy.
- Shaping research & development strategies.
- Optimizing development timelines.
- Driving product development success.
- Understanding nonclinical safety and toxicological assessments.
- Assessing potential risks and regulatory compliance.
Responsibilities:
- Assisting/overseeing nonclinical program strategy development.
- Designing, reviewing, and refining nonclinical/toxicology study protocols.
- Reviewing SOPs, raw data, and reports for compliance and data integrity.
- Identifying, evaluating, and selecting nonclinical vendors.
- Acting as a Sponsor Study Monitor.
- Providing nonclinical toxicology expertise.
- Supporting regulatory submissions.
- Providing strategic nonclinical guidance for market research, due diligence, and product positioning.
- Assisting with business development (proposals).
- Providing day-to-day project support.
- Maintaining up-to-date knowledge of nonclinical regulations (FDA, ICH, WHO, GLP).
- Adhering to LBG quality standards.
- Supporting/leading new business initiatives.
- Contributing to internal tools/system development.
- Travel to client/CRO sites (approx. 3-4 days/month).
Qualifications:
- Advanced degree (MS/PhD) in Pharmacology, Toxicology, or related life science.
- Proven experience in designing and managing non-GLP and GLP studies.
- Experience with study protocols, reports, and regulatory compliance.
- Knowledge of GLP (21 CFR Part 58).
- Understanding of nonclinical CRO operations.
- Strong communication and summarization skills.
- Strong organizational, prioritization, and problem-solving skills.
- Proficient in Microsoft Office 365.
Preferred Qualifications:
- Experience drafting nonclinical study information for regulatory submissions.
- Experience with specialty toxicology studies (reproductive, carcinogenicity, immunotoxicology).
- Experience supporting federally-funded programs.
Compensation & Benefits:
- Salary + Bonus
- Health, dental, vision, life insurance
- Paid time off, parental leave
- Holidays
- 401(k) plan
- College savings/loan repayment plans
- Cell phone stipend
- Parking/mass transit pre-tax account
- Wellness and incentive programs
Diversity, Equity, Inclusion & Belonging:
Sia fosters a diverse, equitable and inclusive environment.
Office Workplace Guidelines:
Flexible workplace policy; consultants in primary market locations (NYC, Charlotte, Seattle, San Francisco) should live within reasonable commuting distance and attend office at least 3 days a week. Flexible in-person requirements for those outside primary markets.
Work Authorization & Sponsorship
Sia does not intend to pursue employment with applicants needing visa sponsorship.
Equal Opportunity Employer
Employment decisions based on performance, competence, conduct.