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 work. The 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 therapies. The 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.
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 how to apply 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 therapeutics. We have a fit-for-purpose philosophy and our projects are specifically designed to answer the unique needs of each individual client. From 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 support. Our 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 selection. Our results have reduced costs and accelerated timelines of drug invention. We 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 trials. We 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 invention. Our team members are innovators and entrepreneurs at heart, and enjoy pioneering this paradigm shift of how drug invention is done. We love to learn, challenge ourselves and others, and create new science and opportunities. Scientists 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 leader. We offer challenging projects and opportunities for development combined with comprehensive benefits and flexible work arrangements that help you balance your professional and personal lives. If interested in joining our team, please send your CV/resume and cover letter to firstname.lastname@example.org.
Applied BioMath is an equal opportunity employer; we take pride in maintaining a diverse and inclusive environment. We 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 law. If you are a candidate in need of assistance or accommodation in the application process, please contact email@example.com.