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SeniorPrincipal ScientistAssoc. Director Clinical Research Group
Job Location:
Monthly Salary:
Not provided by the employer
Monthly Salary:
Experience Required:
8years
Experience Required:
Posted:
5 August 2026 (30+ days ago)
Posted:
Application Deadline:
2 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Clinical Research and regulatory documentation Domain Expertise
- Regulatory submission expertise across CTD/eCTD formats deep familiarity with the Common Technical Document structure (Modules 15) and how CMC (Module 3) nonclinical/toxicology (Module 4) and clinical (Module 5) sections fit together.
Experience preparing submissions for FDA (NDA/BLA/ANDA) EMA and other ICH-aligned agencies.- Hands-on experience drafting or reviewing CMC sections (drug substance/ product specs stability manufacturing)
Hands-on experience in nonclinical toxicology reports/summaries and understanding submission gaps.- Working knowledge of ICH Q (Q1Q14) S (S1S12) E (E1E20) and M (M4 M8) guidelines (ICH guideline fluency (Quality Safety Efficacy series) ) and the format and content expectations across US/Europe and Asian markets.
Track record supporting drug expansion into new regulatory jurisdictions (US EU and others) including gap analyses between regional requirements and adapting dossiers accordingly.
Product Development Support
- Provide subject matter expertise on clinical trials drug development and clinical research processes to the Science AI Data Science and Software Engineering teams to develop clinically relevant products and features.
- Support the design development validation and enhancement of clinical research products and platforms.
- Review and validate clinical workflows protocols study designs and research methodologies used in products and customer solutions.
- Provide insights on industry trends regulations and best practices in clinical research.
- Provide expert knowledge for the development of algorithms data models and clinical decision-support applications.
Customer Solutions & Consulting
- Work with customer-facing teams to understand client requirements and provide clinical expertise.
- Support solution design demonstrations presentations and proposal development.
- Assist in addressing clinical and scientific queries from customers.
- Participate in customer workshops and stakeholder discussions.
Qualifications and Work Experience
- PhD/MSc in Pharmacy PharmD Life Sciences Biotechnology Medicine Clinical Research.
- Experience working for Pharma or CRO companies in clinical trial design and documentation group and/or Medical Affairs team.
Relevant certifications credentials such as RAC (Regulatory Affairs Certification from RAPS) a regulatory affairs/medical writing certification (e.g. AMWA DIA) or an advanced degree (PharmD PhD in life sciences) combined with 810 years in regulatory writing/CMC-toxicology documentation.
Required Skills:
810 years in regulatory writing/CMC-toxicology documentation
Required Education:
PhD/MSc in Pharmacy PharmD Life Sciences Biotechnology Medicine Clinical Research.
About Company
Over a decade of experience in helping Fintech, Agritech and Healthtech companies develop and maintain impactful, transformational IT systems and “insight” generating data infrastructure.
