Director- CRO Management (Regulated Bioanalysis) - Regeneron Pharmaceuticals, Inc.

We are seeking a highly motivated Director to join to our Bioanalytical Sciences team. You will be responsible for coordination of assay development/qualification/validation efforts on various analytical platforms as well as the subsequent sample analysis and reporting efforts for each drug program. You will be responsible for communicating progress on these deliverables to the appropriate nonclinical and clinical colleagues and project teams. We hope you are excited by the opportunity to serve as subject matter expert for external bioanalytical assay strategy and data interpretation.

As a Director, a typical day may include the following:

• Providing scientific and operational oversight of on all aspects of bioanalytical activities conducted at Contract Research Organizations (CROs)

• Providing scientific support to CRO efforts in design, development, and implementation of a variety of analytical methods in a regulated (GLP, GCLP) environment and ensure that these activities are in line with current regulatory guidelines

• Working with internal and external SMEs (Subject Matter Experts) to address any/all issues that may occur during assay development and/or sample analysis

• Collaborating with CROs to ensure on time delivery of required milestones and proactively communicate with the CRO to ensure transparency and adherence to the timelines, availability of required contracts, quotes, purchase orders etc.

• Providing CRO with critical material, obtain and archive needed documentation, work with CRO to reconcile any scientific or operational concerns, manage standing review meetings, arrange vendor visits as appropriate

• Facilitating with the review of GLP and GCLP compliance status at CROs

• Developing of a strategic plan to cover all outsourcing activities for BAS

• Developing of a team to handle all outsourcing activities

This role might be for you if:

• You have strong communication skills and can efficiently work in a cross-functional environment

• You enjoy participating in, preparing, and presenting scientific data at internal and external project team meetings

• You have excellent multi-tasking skills and the ability to be flexible with changing priorities

• Have the ability to think creatively and strategically with a strong problem-solving mentality

• Have experience in leading teams and cross functional collaborations and enjoy mentoring others

In order to be considered for this role, you must have at least BS/MS and 20+ years of relevant experience in regulated bioanalysis or related field; a Ph.D. with 15+ years of relevant experience will also be considered. We need someone with a minimum of 8-10+ years of experience with outsourcing regulated bioanalytical assays and oversight of CRO activities required. Hands-on experience with bioanalytical techniques such as ELISA, ECL, MSD, LC/MS, PCR-based methods is required. We need someone knowledgeable of bioanalytical regulatory guidances, including the GLPs, and industry standard practices for conducting nonclinical bioanalysis. Must have experience with writing/reviewing bioanalytical reports and contributing to regulatory submissions.

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)