Senior Manager Genetic Clinical Sciences

The Senior Manager of Genetic Clinical Sciences works independently with minimal supervisor oversight, leads other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Phase 3. We expect the Sr. Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and / or late phase development.

A typical day may include the following :

• Facilitates / Leads the writing of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
• Identifies key internal and external collaborators / advisors, organizes and conducts consultations with global subject matter experts
• Represents the clinical genetic medicine function on clinical study teams, contributing medical / scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
• Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
• Drafts and review 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

This role may be for you if :

To be considered for this role, we require a Bachelors Degree Advanced degree or equivalent education / degree in life science / healthcare preferred (PhD / MD / PharmD / MSc). Additionally, we are seeking 6 or more years of pharmaceutical clinical drug development experience. We would like to see proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing skills. Knowledge of clinical development process, regulatory requirements and ICH / GCP guidelines. We desire aa proven track in clinical trial process improvements. We need prior experience with organizational awareness, including significant experience working cross-functionally. Other levels considered depending on experience. Lastly, this is not a remote role and requires 3 days in the office each week.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and / or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

173,500.00 - $283,100.00

Salary : $173,500 - $283,100