Description

We are seeking a Senior Manager to join our Clinical Sciences team within Regeneron Genetics Medicine. 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 Senior Manager, a typical day may include the following:

- Supports the cross-functional study team on the following activities, including but not limited to:

- 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

- Represents the clinical genetics 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 portions of the clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator’s 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

- Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.

- 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.

- Provides background literature searches in support of:

- Early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints

- 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 Bachelor’s degree. Ph.D., PharmD. or Master’s degree in biomedical subject. Additionally, we are seeking 8 years of clinical research/development experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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)

$150,500.00 - $245,500.00

Senior Manager, Clinical Scientist, Genetics Medicine

Description

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