Modeling & Simulation - Scientific Fellow II
Modeling & Simulations plays an increasingly important role in the development of new drugs within Vertex Pharmaceuticals and our goal is to fully implement Model based principles to support drug development program in terms of translational modeling, clinical study design, evaluation and decision making.
We are now seeking an experienced Pharmacometrician to our Modeling & Simulations Department to help us achieve this vision.
The successful candidate will be responsible for developing and executing M&S strategies in several cross functional drug development project teams and work in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Clinical Biomarkers, Clinical Development and other colleagues within the clinical and preclinical organization. The successful candidate will play a key role in building the Pharmacometrics capability within Vertex by providing technical and strategic support to other modelers within the Department, organize training as needed and contribute to building a sustainable Modeling infrastructure.
- As M&S lead in one or more cross functional drug development teams, provide modeling and quantitative expertise, develop Modeling & Simulation plans that are integrated with the clinical development plans, contribute to optimal trial design, support dose and patient selection, perform population based PK and dose/exposure response analyses and clinical trial simulations (either internally or indirectly via Pharmacometric vendors), interact with regulatory authorities and contribute to IND and NDA filings.
- Strongly contribute to the implementation of pharmacometric/modeling strategies and state of the art methodologies across projects and disease areas to improve critical decision-making regarding: clinical trial simulation, optimal study design, adaptive design methodologies, dose selection, probability of success estimation etc.
- Provide technical and tactical guidance to other Modeling colleagues within the M&S department on a day-to-day basis and contribute to internal training sessions in relevant areas as needed.
- Establish strong relationships with colleagues within Biostatistics, Clinical Pharmacology, Clinical biomarkers, DMPK and other quantitative disciplines within Vertex.
- Establish and build strong connections with M&S colleagues within top Academic institutions.
- Take a leading role in the evaluation of new Pharmacometric tools and contribute to a strong and sustainable computational infrastructure for degenerative diseases.
- PhD (with an emphasis on pharmacometric methodologies) in: pharmacokinetics, pharmacodynamics, clinical pharmacology, statistics, engineering, or other quantitative discipline.
- 10+ yrs hands-on experience in the application of Pharmacometric and other quantitative methodologies within the context of drug development.
- Expert knowledge in population-based PK, PKPD, exposure/dose response analyses, clinical trial simulation, Bayesian approaches, Meta analyses, Adaptive designs.
- A solid understanding of pharmacokinetic and PKPD principles .
- Excellent programming skills (e.g. NonMem, R, S Plus, SAS.or other tools).
- Demonstrated strong leadership and influencing skills.
- Excellent oral and written communication skills.
- A demonstrated ability and aspiration to collaborate with colleagues within and outside your own discipline to reach a common goal.
- Demonstrated strong experience from interactions with regulatory authorities and good insight into regulatory guidelines and expectations with respect to the use of model based methodologies in e.g. NDA filings, EoPh2 meetings etc.
- Experience from the application of System pharmacology in a drug development context
- Modeling Experience from disease areas like pulmonary diseases, Oncology and Vertex creates new possibilities in medicine.
Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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