The Senior Manager, Pharmacy Support Lead (PSL) is responsible for driving activities related to Investigational Product used in the conduct of clinical research projects to ensure consistent deliverable of program objectives across our portfolio. In particular, the role partners with Formulation Development Group (FDG), as a SME in investigational product handling, preparation, and administration. As such, the role drives creation of documentation & training materials to ensure that best practices for IP management are upheld and looks for opportunities to improve the process. Focuses on clinical site research pharmacy support in compliance with applicable federal (CFR and ICH E6) and state regulations, international standards and regulations, good clinical practices, and institutional policies and procedures. The role provides consultation and lends expertise to Clinical Drug Supply & Logistics Organization (CDSL), the Formulation Development Group (FDG), the Clinical Trial Management Team (CTM), and partner groups on investigational products and medication/device related issues, such as aseptic IP preparation, concomitant medications, Instructions for Use (IFU), and patient compliance/adherence issues.

A typical day as a Sr Manager in this role looks like:

• Partners with the CDSL Managers, the Formulation Development Group (FDG), Regulatory Sciences (RS)/ Affairs (RA), as well as members of the Clinical Trial Management team (CTM) including the Clinical Study Lead (CSL), Study Medical Director (SMD) and Clinical Scientist (CS), Quality Management Lead (QML ).

• Provides consultation on various pharmaceutical aspects including site pharmacy operations as pertains to ancillary supplies, investigational product (IP) labeling & design, blinding issues, preparation, and administration of IPs for all REGN-funded/sponsored clinical trials.

• Provides technical expertise for the development of clinical study documents and pharmacy manuals and will assist in development of admixture, dosing, and administration strategies for complex biologic products and gene therapies.

• Collaborates with key partners to drive study activities including development of Pharmacy Manuals and associated forms, ensuring research site pharmacy requirements, and provides communication and coordination of pharmacy related activities.

• Works closely with Clinical Operations, CRO representative and pharmacy site personnel to coordinate matters related to the clinical trial IP, including:

• ensuring that the proposed IP and its placebo used in the clinical trial will maintain the blind during preparation and administration and meet regulatory requirements for use in the proposed country.

• triage and review of ancillary supplies compatibility requests in conjunction with FDG utilizing search queries and entry in the associated database.

• review and resolution of practice-based deviations and violations involving the IP/placebo during the trial.

• Responsible to determine, resolve and/or escalate any issues related to, but not limited to:

• quality assurance questions/issues related to the IP/placebo,

• any errors that occur in drug preparation and administration to trial participants,

• questions proposed by the clinical trial sites regarding IP preparation and administration.

• Partners closely with Clinical Ops and Clinical Study personnel during protocol development, protocol progress, and subsequent amendments.

• Lends expertise to Site Initiation Visits (SIV), Investigator meetings (IM) and provides study specific pharmacy training to site monitors and participating sites as needed.

• Establishes and consolidates data from Site Feedback mechanisms and support efforts to continually improve processes to meet Sponsor and site needs in an efficient and consistent manner.

• Aids in training/ on-boarding of new colleagues and development of training material for internal and external stakeholders.

This role may be for you if you have:

• Experience in sterile product preparation/administration experience.

• Strong understanding of drug product infusion via various route of administration.

• Understanding of Clinical Supplies / Clinical Trial design.

• Must be able to effectively communicate across all levels; analytical problem-solving experience; must be able to develop and present varied and unique ideas; effective influence and negotiation skills.

• Ability to build successful collaborations with internal and external partners; Must have strong communication skills; verbal, written, and presentation; Must have broad knowledge and cross-functional understanding of clinical trial methodology; Working knowledge of GCP and ICH principles. Knowledge of PCAB, FDA, NABP/VPP, USP 795 & 797, EU CTR guidelines.

In order to be considered qualified for this role, a minimum of a Bachelors Degree in Pharmacy or Nursing, or PharmD is required, and at least 8 years of relevant experience in Hospital or Clinical Research or equivalent pharmaceutical/biotech industry experience.

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)

$129,800.00 - $211,800.00