We are seeking a Manager to join our Clinical Sciences team within Early Clinical Development. Qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. You will work closely with supervisor and other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC).
As a Manager, a typical day may include the following:
Contributes to the writing of sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments
Assists with identifying key internal and external collaborators/advisors, organizes consultations with global subject matter experts and works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
Represents the clinical ECD&ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
Drafts portions of the clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigators brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
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 and Identifies program, trial or data risks, creates and implements mitigation strategies
Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
Provides background literature searches in support of Early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints as well as POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy
This role may be for you if:
Effective communications (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
To be considered for this role, you must have a Bachelors degree. Ph.D., PharmD. or Masters degree in biomedical subject. Additionally, we are seeking 3-6 years of clinical research/development experience.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$121,200.00 - $197,800.00