Senior/Principal Scientist/Assoc. Director Clinical Research Group

Clinical Research and regulatory documentation Domain Expertise<\/span><\/span><\/b>
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• 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.<\/span><\/span>
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  Experience preparing submissions for FDA (NDA\/BLA\/ANDA), EMA, and other ICH\-aligned agencies.<\/span><\/span><\/li>\n
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• Hands\-on experience drafting or reviewing CMC sections (drug substance\/ product specs, stability, manufacturing)<\/span><\/span>
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  Hands\-on experience in nonclinical toxicology reports\/summaries and understanding submission gaps.<\/span><\/span><\/li>\n
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• -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.<\/span><\/span>
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  Track record supporting drug expansion into new regulatory jurisdictions (US, EU, and others), including gap analyses between regional requirements and adapting dossiers accordingly.
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  Product Development Support<\/span>
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  • 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.<\/span>
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    • Support the design, development, validation, and enhancement of clinical research products and platforms.<\/span>
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      • Review and validate clinical workflows, protocols, study designs, and research methodologies used in products and customer solutions.<\/span>
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        • Provide insights on industry trends, regulations, and best practices in clinical research.<\/span>
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          • Provide expert knowledge for the development of algorithms, data models, and clinical decision\-support applications.<\/span>
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            Customer Solutions & Consulting<\/span>
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            • Work with customer\-facing teams to understand client requirements and provide clinical expertise.<\/span>
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              • Support solution design, demonstrations, presentations, and proposal development.<\/span>
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                • Assist in addressing clinical and scientific queries from customers.<\/span>
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                  • Participate in customer workshops and stakeholder discussions.<\/span>
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                    Qualifications and Work Experience<\/span>
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                    • PhD\/MSc in Pharmacy, PharmD, Life Sciences, Biotechnology, Medicine, Clinical Research.<\/span>
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                      • 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.
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