Current openings
Opportunities at Nikao Life Sciences
1. Nonclinical Program Manager
Location: Remote / US | Type: Full-time
The Nonclinical Program Manager will oversee the design, execution, and delivery of nonclinical studies supporting regulatory submissions (IND, CTA, NDA, BLA). This role requires deep scientific understanding and operational leadership across toxicology, pharmacology, and ADME disciplines.
Key Responsibilities
- Develop and manage integrated nonclinical program plans aligned with clinical and CMC objectives.
- Coordinate study design, protocol review, and vendor management.
- Oversee CRO selection, qualification, and performance tracking.
- Monitor study progress, data integrity, and GLP compliance.
- Interface with clients, CROs, and internal teams to ensure timelines and deliverables are met.
- Support preparation of regulatory documentation and study summaries.
Qualifications
- Advanced degree (PhD, DVM, or MS) in toxicology, pharmacology, or related field.
- 7+ years of nonclinical or preclinical program management experience.
- Strong knowledge of GLP and ICH guidelines.
- Experience with IND/BLA-enabling studies preferred.
- Excellent communication and client management skills.
Interested candidates can submit their resume to careers@nikaolifesci.com with the subject “Nonclinical Program Manager Application.”
2. Regulatory Writer (IND/BLA/MAA)
Location: Remote / Hybrid | Type: Contract / Full-time
The Regulatory Writer will author and review submission documents for global health authority filings (IND, CTA, NDA, BLA, MAA). This role requires strong technical writing skills and deep familiarity with nonclinical data and regulatory expectations.
Key Responsibilities
- Write, review, and edit high-quality regulatory documents including IBs, NDAs, BLAs, and MAAs.
- Ensure scientific accuracy, data consistency, and compliance with GLP/ICH standards.
- Collaborate with scientific and regulatory teams to gather and interpret data.
- Develop summaries, position papers, and briefing documents for health authority meetings.
- Maintain document QC and version control processes.
Qualifications
- Advanced degree in life sciences or related discipline..
- 5+ years of experience in regulatory writing for pharma or biotech.
- Proven experience with IND/BLA/MAA document preparation.
- Familiarity with eCTD structure and submission standards.
- Exceptional written communication and attention to detail.
Submit your application and written samples to careers@nikaolifesci.com with the subject “Regulatory Writer Application.”
3. Toxicology Study Oversight Consultant
Location: Global (US, EU, India, China) | Type: Consultant
The Toxicology Study Oversight Consultant will provide expert guidance and monitoring for nonclinical safety studies, ensuring compliance, quality, and scientific integrity. This role is ideal for an experienced toxicologist or study director seeking a consulting engagement.
Key Responsibilities
- Design and review toxicology and safety pharmacology study protocols.
- Conduct oversight of CRO performance and GLP compliance.
- Evaluate study data for accuracy, integrity, and regulatory readiness.
- Provide interpretation of findings and contribute to risk assessments.
- Support regulatory submissions and agency interactions as subject matter expert.
Qualifications
- DABT certification or equivalent strongly preferred.
- 10+ years of experience in toxicology or preclinical safety.
- In-depth knowledge of OECD and ICH guidelines.
- Prior experience with study monitoring and CRO interactions.
- Strong scientific judgment and independent consulting skills.
To express interest, email careers@nikaolifesci.com with “Toxicology Consultant Application.”
4. Business Development Associate
Location: Remote | Type: Part-time / Contract
The Business Development Associate will support growth initiatives by identifying opportunities, developing client relationships, and coordinating outreach within biotech, pharma, and medical device sectors.
Key Responsibilities
- Conduct market research to identify new clients and partnership opportunities.
- Support proposal development, capability presentations, and lead tracking.
- Coordinate with technical teams to align client needs with service offerings.
- Maintain CRM systems and contribute to business development strategy.
- Represent Nikao Lifesciences in virtual or in-person industry events.
Qualifications
- Bachelor’s degree in life sciences, business, or related field.
- 2–4 years of experience in business development or client relations (preferably biotech/pharma).
- Excellent communication and organizational skills.
- Familiarity with nonclinical or regulatory services a plus.
- Self-motivated with a consultative and professional approach.