Senior Scientist, non-clinical & clinical PK/PD Modeling and Simulation
Role at Almirall.
Overview
Senior Scientist, non-clinical & clinical PK/PD Modeling and Simulation – Almirall
Mission
Define and drive non-clinical and clinical PK/PD strategies for NCE, NBE or other drug modalities, through modeling & simulation tools to support hypothesis generation, candidate selection, human dose predictions, design of clinical trials or regulatory interactions. Provide guidance with respect to common model informed drug development (MIDD) needs, such as population PK (PopPK), Exposure-Response (ER), PBPK or Quantitative Systems Pharmacology.
Responsibilities
* Lead the implementation of currently unavailable M&S tools & capabilities within the company.
* Engage proactively in discovery and development projects with M&S needs for NCEs, NBEs or other drug modalities in a multidisciplinary environment.
* Devise the PK/PD strategy and use of M&S to support the design of in-vitro/in-vivo mechanistic studies.
* Deliver PK, PK/PD or PBPK modelling to support the optimization of drug candidates in preclinical projects of different modalities.
* Strong interaction with translational medicine and clinical teams to guide dose selection.
* Human PK predictions to estimate efficacious exposure/dose and support the clinical development program (e.g. PopPK & ER).
* Balance the needs of M&S in R&D projects according to available internal capabilities or through outsourcing to pharmacometric CROs.
* Provide M&S support/review for IND / NDA / BLA submissions.
* Foster a continuous update of scientific M&S knowledge to keep up high standards within the Company.
Education
* Bachelor of Science, Master of Science or PhD (PhD degree in a field related to pharmacometrics is preferable) in Pharmacokinetics, Pharmacology, Pharmaceutical/Biotechnological Sciences, Biomedical/Chemical Engineering, Applied Mathematics, or a health related discipline.
Specific Knowledge
* Good understanding of translational medicine aspects to connect preclinical and Clinical DMPK.
* Comprehensive understanding of pharmacokinetics and pharmacodynamics during drug discovery & development.
* Good understanding of the Principles for Model-Informed Drug Development.
* Proven skills in PK, PK/PD, PBPK and/or longitudinal disease modelling.
* Proficiency and extensive hands-on experience with modeling software such as MATLAB, R, Phoenix, or NONMEM, among others.
Experience
* At least 5 years of experience in the field (preferentially in an industrial environment).
Competencies
* Teamwork and personal leadership.
* Ability to work in a matrix environment, multi-task, meet deadlines and deal with evolving priorities.
* Strategic thinker with leadership skills and the ability to work collaboratively across various teams and disciplines.
* Capable of building and maintaining professional networks to support collaborative efforts.
* Fluent in both oral and written English, essential for effective communication and documentation.
* Excellent inter-cultural understanding.
Why work with Almirall? We are a people-centric company where employees are at their best, patients and customers are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.
Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time. This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to the fullest and grow both professionally and as individuals.
We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions. We are proud of each one of our employees, their development, and growth: they are the success of the company.
Our purpose: Transform the patients' world by helping them realize their hopes & dreams for a healthy life.
Our values:
* Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
* Courage: we challenge the status quo, we take full ownership and we learn from our success & failures.
* Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
* Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
At Almirall, it’s all about people!
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