The Associate Director, Clinical Scientist is a qualified scientist with experience in the pharmaceutical/biotechnology sector, or academic clinical setting. This individual works with supervisor and other members of the cross-functional study team to author and contribute to clinical development documents and facilitate execution of study activities and data summarization.
A day in the life includes the following responsibilities:
- Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
- Trains and support study team and CRO personnel regarding clinical aspects of trial
- Accountable to the Clinical Lead for the project for a specific trial for: first-line medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
- Maintains and develops relationship with key study investigators, organizes steering committees, advisory boards, and data safety monitoring boards as required
- Identifies program, trial or data risks, creates and implements mitigation strategies
- Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
- Responsible, with input from Medical Monitors, Clinical Trial Management Biostatistics and Data Management for timely clinical data review and quality of deliverables.
- Reports to supervisor and management on clinical trial findings and milestones
This job may be for you if you have the following:
- An Advanced Degree (Pharm D or PhD)
- 6-8 years of clinical research/development experience, preferred.
- Effective communication (verbal & written) and presentation skills are essential.
- Must be able to work productively in a fast-paced collaborative environment.
- Demonstrated/potential for critical thinking skills and sound decision-making.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-SC1 #GDECDJobs