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As an Associate Director Clinical Pharmacology this individual is expected to proactively-identify and provide significant Pharmacometrics (PMx) contributions potentially of a complex nature for research and development programs. They are expected to address strategically important program needs that represent scientific advancements of one or more programs and/or aptly address significant regulatory hurdles. Is regarded as an expert in the field; as such is able to contribute to the overall strategic program development and is able to communicate complex PMx strategies and results in an influential manner to the development team. They are also expected to independently design, conduct and oversee the development of PMx analysis plans and applies standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses.

A day in the life an Associate Director may look like:

• As a PMx Program Representative on program teams, effectively communicate complex PMx results in colloquial terms and understandable to the development teams with the ability to be influential with the development team.

• Independently plans and conducts or otherwise oversees the development of PMx analysis plans and applies standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses and has final responsibility for ensuring the accuracy of analyses.

• Independently authors PMx contributions to regulatory documentation, including those for pre-IND, EOP2, and pre-BLA meetings. Performs additional analyses as required to support regulatory interactions.

• Is able to Independently draft and review documentation for accuracy, clarity and messaging to ensure documents are appropriate for further PMx management review.

• With limited guidance from senior departmental staff, works directly with development or Research teams on PMx elements of program strategy and the PMx aspects of study

• design and results at management forums (RPR, DPR and PRC).

• Contributes to the development of accurate tables and figures for inclusion in slides for senior management presentations.

• In conjunction with PMx management, is responsible for contributing to the drafting of PMx program strategies to support one or more standard programs.

• Provide leadership support to a study team on all relevant PMx deliverables and objectives and independently leads a project.

• Represents PMx at routine pre-IND, Type C, pre-BLA, and other HA meetings.

This may be the right role for you if you:

• Understanding of PMx concepts and techniques, such as advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods, compartmental modeling, translational modelling/pharmacology, Exposure-Responses analysis methods, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP*.

• Knowledge of innovative PMx methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, and strategies for handling missing data.

• Has good regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory review and approval of BLA or equivalent.

• Ability to formulate PMx objectives, design, and analyses for complex clinical projects.

• Proficient in use of MS-Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN, working in department computing environment

To be considered for this role you must have:

A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree and at least 6 years of relevant Clinical Pharmacology 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)