This job has expired

You will need to login before you can apply for a job.

Assoc Director, Quantitative Pharmacology

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Sep 19, 2022

View more

Discipline
Science/R&D, Pharmacology
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
You need to sign in or create an account to save a job.

Job Details

As an Associate Director this individual is expected to proactively-identify and provide significant PMx contributes potentially of a complex nature for research and development programs that address strategically important program needs, and 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.

Independently designs 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. Informs PMx management of results and issues in a timely manner.

With an advanced knowable of the field and know willingness to provide mentorship, is regarded as a scientific leader in PMx.

Is responsible for the preparation and timely delivery of accurate and well-articulated nonclinical or clinical study reports and regulatory submission documents as appropriate.

As are all individuals in PMx, the Associate Director is responsible for the adherence to all applicable SOP’s and PMx working practices, and the corporate code of ethical conduct.

Responsibilities

*Individual responsibilities may differ between PMx disciplines

  • 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.

  • Is responsible for mentoring and actively aiding in the professional development of other individuals in PMx.

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

  • Contributes to and/or leads technical working groups, providing support for process

    improvement initiatives.

  • Contributes to and/or leads new/revised SOPs and cross-functional workstreams.

  • is responsible for the adherence to all applicable SOP’s and PMx working practices, and the corporate code of ethical conduct.

  • Actively publishes work in scientific literature.

Knowledge*

* Individual skill and Knowledge may differ between PMx disciplines

  • 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 clearly describe advanced PMx techniques and interpret results.

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

  • Excellent communication & strong negotiation skills, and able to manage internal team and CROs.

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

Job Complexity

  • Able to handle almost all types of projects and leverage higher level staff for technical input and brainstorming to implement solutions for complex projects. Able to work with ambiguity.

  • Ability to inspire internal staff to be active professionally and help them achieve external presence. Good mentorship. Able to represent PMx on initiatives or serve as a leader for initiatives, and able to reach into the organization to accomplish results.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

FacebookTwitterInstagramYouTube Logo

Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert