Description du poste
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 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)