Senior Manager, Clinical Scientist, Genetics Medicine

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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)