Senior Scientist / Principal Scientist / Associate Director - Clinical Research

Senior/Principal Scientist/Assoc. Director Clinical Research Group Clinical Research and regulatory documentation Domain Expertise Regulatory submission expertise across CTD/eCTD formats — deep familiarity with the Common Technical Document structure (Modules 1–5) 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 (Q1–Q14), S (S1–S12), E (E1–E20), 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 8–10+ years in regulatory writing/CMC-toxicology documentation. Experience Level Senior Level