Senior Distinguished Scientist

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

The Quantitative Science Services Team is responsible for supporting quantitative decision-making and evidence generation in drug development through the strategic application of modeling and simulation and other types of data gathering, analysis, and interpretation. This position will help building bridges between 1) the QSS team and its services, 2) mechanistic Model Informed Drug Development (MIDD) approaches (PBPK/QSP) and 3) Certara software, further establishing Certara as the premier integrated MIDD solutions provider worldwide. A key role will be to support internal and client teams to achieve optimal impact with their MIDD strategy for drug development and regulatory decision making. This is a highly collaborative, strategic role working internally across teams and as a 'solutions architect' for clients.

• Working as 'solutions architect' with internal and client teams to develop fit-for-purpose MIDD strategies for complex drug development programs. Provide input into the deliverables from those strategies to ensure optimal impact on development decisions and regulatory decision making.

• Based within QSS, a cross-Certara integrator role around MIDD and data science capabilities and technologies.

• By leveraging existing capabilities and technologies across Certara, identify opportunities to build integrated model-informed drug development (MIDD) solutions that will help our clients to enhance their decision-making processes.

• Work with the marketing and business development teams and other CDDS colleagues to promote Certara MIDD solutions to expand the client base as well as the depth of engagement with current clients

• Accountable for helping QSS team members to generate and lead strategic scientific consulting projects, making a positive impact on client projects and supporting business growth and serving as a billable consultant (~30% of time billable)

• Member of the QSS Leadership team, and participate internally in initiatives to develop and promote bridging between QSS pharmacometrics capabilities and other MIDD/Data science solutions

• Drive thought leadership (internally and externally) on the application of integrated MIDD approaches across the entire pharmaceutical value chain and in regulatory decision-making

• PhD or PharmD degree or associated degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.

• >10 years of experience in pharmaceutical development companies.

• Experienced in designing and executing clinical pharmacology studies.

• Experience with translational and clinical pharmacology work at different stages of development and for regulatory submissions (e.g., INDs, NDAs, and BLAs).

• Knowledge of regulatory documents required for IND and NDA/BLA submissions.

• Knowledge of the application of pharmacometrics approaches to support drug development.
• Experience with a broad range of clinical pharmacology and quantitative tools, including but not limited to WinNonLin, Phoenix, R, and other PK/PD analysis software.
• Experience with supporting and coordinating multiple studies and/or tasks as requested.