We are currently seeking a talented and innovative senior scientist to join our team in concord, ma, (the boston/cambridge area), oakland, ca (the bay area)We may be able to accommodate flexible work arrangements including remote workThe candidate will be responsible for providing pharmacometrics support to pharmaceutical and biotech clients developing drugs across a range of modalities, from small molecules to biologics to bispecifics and gene therapiesThe candidate will work on cross-functional development teams and characterize the relationship between dose, exposure, and response to answer key development questions, supporting optimal dose and regimen selection across all stages of preclinical and clinical development.
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Duties and responsibilities:
This position is responsible for, but not limited to, the following:
Establish translational models to predict human pkpd from preclinical data and support entry of new drugs into first-in-human clinical studies
Develop fit-for-purpose modeling and simulation strategies to address client needs
Perform population pk and pkpd analysis to inform client decision-making, support regulatory interactions, and optimize dose and regimen selection across all stages of clinical development
Perform literature searches and text mining to help inform model development
Conduct simulations to inform optimal clinical trial designs
Author modeling and simulation reports and components of regulatory documents, including inds, csrs, clinical trial protocols, blas and ndas, briefing books, and responses to inquiries from regulatory authorities
Participate as representative on multiple internal and customer project teams and contribute to defining expertise-related aspects of overall program goals
Keep abreast of relevant literature, modeling approaches, and software to continuously advance pharmacometrics expertise and capabilities
Maintain outside visibility, preparing posters and manuscripts for publication
Qualifications, skills and abilities:
Master’s degree in engineering, pharmacometrics, clinical pharmacology, pharmaceutical sciences, mathematics, physics, or a related field with at least 2 years of relevant experience in the pharmaceutical and biotech industry
Phd in engineering, pharmacometrics, clinical pharmacology, pharmaceutical sciences, mathematics, physics, or a related field
Extensive experience with population pk and pkpd modeling, direct and indirect response models, and exposure-response modeling
Understanding of adme, pharmacokinetics, pharmacodynamics for small and large molecules and of the drug discovery and development process
Hands-on proficiency with nonmem, monolix, or other non-linear mixed effects modeling software, r and phoenix; familiarity with matlab is a plus
Strong interpersonal, oral, and written communication skills, with the ability to effectively articulate modeling and simulation strategies and results to diverse groups including other modelers, biologists, clinicians, and other members of clients’ development teams
Ability to manage multiple projects simultaneously and deliver work in a timely manner
Record of scientific achievement through peer-reviewed publications, invited oral presentations, or patents
The following is a plus, but not required:
Experience with systems modeling or other ode modeling of complex biological systems
Knowledge of model-informed drug development with a good understanding of Apply Now modeling tools to inform drug development decisions
Work environment and physical requirements:
General office environment
Requires approximately 0-10% domestic travel
May work remotely, or in either our concord, ma or pleasanton, ca office
Applied biomath (www.appliedbiomath.com) is a rapidly growing, people-focused, organization that uses innovative modeling and simulation approaches to revolutionize drug invention and accelerate drug development for cutting-edge therapeuticsWe have a fit-for-purpose philosophy and our projects are specifically designed to answer the unique needs of each individual clientFrom systems models that integrate disease pathophysiology with therapeutic mechanisms of action to population pharmacokinetic models to complex exposure-response models and model-based meta analyses, we offer a comprehensive suite of modeling and simulation services combined with strategic drug development supportOur analyses have assisted both large and small pharma and biotechs to: prioritize portfolios, identify knowledge gaps, prioritize and design experiments, predict optimal drug properties, and support clinical trials and indication/patient selectionOur results have reduced costs and accelerated timelines of drug inventionWe work closely with drug program teams, scientists, program managers, protein engineers, and chemists, as well as senior managers, to best affect the outcome of drug programs in research, development, and clinical trialsWe are frequently thought of as a member of the project team.
At applied biomath, our passion for science, technology, and helping patients is what drives our desire to revolutionize drug inventionOur team members are innovators and entrepreneurs at heart, and enjoy pioneering this paradigm shift of how drug invention is doneWe love to learn, challenge ourselves and others, and create new science and opportunitiesScientists and all team members at applied biomath have the rare opportunity to work across therapeutic areas on treatments ranging from traditional small molecules and monoclonal antibodies to the most innovative modalities, like gene therapies, cell-based therapies, conditionally active therapeutics, antibody-drug conjugates, bispecific and multispecific antibodies, prodrugs, protein degraders, rna-based therapies - here, you’ll see it all! as a member of our team, you’ll be on the forefront of drug discovery and development in an exciting, collaborative environment that supports your growth as a leaderWe offer challenging projects and opportunities for development combined with comprehensive benefits and flexible work arrangements that help you balance your professional and personal livesIf interested in joining our team, please send your cv/resume and cover letter to careers@appliedbiomath.com or visit our linkedin job page.
Applied biomath is an equal opportunity employer; we take pride in maintaining a diverse and inclusive environmentWe will not discriminate in recruitment, hiring, training, promotions or any other employment practices on the basis of age, color, disability, gender identity, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local lawIf you are a candidate in need of assistance or accommodation in the application process, please contact peopleservices@appliedbiomath.com.
