The Sr. Clinical Scientist is responsible for ethical, medical, and scientific rigor in development, conduct and reporting of assigned clinical studies. Responsible for medical and scientific quality in the design, planning, initiation, and successful completion of assigned clinical trials for new or marketed drugs for all phases of clinical development. Interacts with KOLs and other external experts to ensure appropriate and rigorous study design in selected indications.
Essential Duties & Responsibilities
- Provide scientific input to clinical studies.
- Write, edit, and review medical and scientific elements of clinical research, operational and regulatory documents, including but not limited to synopses, protocols, CRFs, informed consent templates, feasibility assessments statistical analysis plans, regulatory documents (eg, IND, MAA, NDA, PIP), key study plans, and clinical study reports to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency.
- Ensure validity, accuracy, relevance, and completeness of medical and scientific content in clinical research and regulatory documents.
- Lead and delegate clinical data review tasks and data analysis to ensure data quality and consistency, including the identification of data and query trends to contribute to overall data quality. Lead responses to competent authority questions, as requested.
- Establish and maintain quality corporate relationships with leading investigators and clinical sites on assigned protocols in collaboration with Clinical Operations team.
- Contribute to the development of global regulatory strategies.
- Provides training and support to sites and CRAs at Investigator Meetings and other events as needed.
- Establish and maintain effective communication and collaboration with functional area peers, including study teams, data management, biostatistics, regulatory, among others.
- Participate in development of publication strategies, writing and editing of draft presentations and manuscripts and interface with external vendors and authors.
- Support the review and approval of promotional material, labeling, and training material pertaining to assigned product.
- Share scientific knowledge with the organization during continuing education sessions and CRA and vendor trainings, at an adapted level of understanding.
- All other duties as assigned.
Experience & Qualifications
- PhD, PharmD or MD with demonstrated industry experience in clinical research and drug development, minimum 5 years preferred experience in the biopharmaceutical industry in clinical science, clinical research, or equivalent.
- Experience in AD and PD or neurodegenerative diseases.
- Proven track record of successful protocol development, execution, and reporting in industry.
- Understanding of pharmaceutical business, worldwide drug development and regulatory process.
- Excellent interpersonal communication, collaboration, organization, and presentation skills.
- Solid understanding of clinical trial design, biostatistics, and data analysis.
- Familiarity with ICH and GCP.
- Strong project management skills.
"Roll-up-the-sleeves" attitude.
