Certara is hiring a Senior Director / Director Pharmacometrics to support our Strategic Consulting - Integrated Drug Development group. We are looking for the top experts in the field of Pharmacometrics; this position will be at either the Senior Director or Director level based on the experience of the selected candidate. This role can be located anywhere in Europe and it can be home based.
About our Strategic Consulting - Integrated Drug Development
Certara Strategic Consulting is the largest pharmacometric organization in the world, which enables us to offer various career pathways that match the ambition and personal interests of our employees! We are a division of Certara and deliver value by integrating advanced modeling and simulation approaches into the most crucial drug development deliverables-to inform internal decision-making and strengthen global regulatory submissions. Leveraging our collective experience working on thousands of key drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.
In this role you will play a pivotal part in supporting and leading client early and late clinical development engagements by providing scientific and strategic pharmacometrics input that addresses key questions in their development programs, clinical study design considerations, model-informed drug development strategies, as well as interactions with and submissions to regulatory authorities. Additionally, you will have the opportunity to mentor colleagues and drive company initiatives that keep Certara at the forefront of innovation in model informed drug development.
Our Pharmacometricians are responsible for providing expertise into clinical development plans, including the design, conduct, and interpretation of relevant clinical pharmacology and PKPD studies.
Qualified candidates will have the ability to work on a variety of therapeutic indications and data types and must be experts in applied Population PK and PK/PD modelling and simulation to help design and conduct PK/PD modelling and simulation to support drug development.
We are looking for Pharmacometricians that want to:
- Deepen their strategic drug development expertise and their experience informing drug development decisions.
- Hone their pharmacometric techniques with fit-for-purpose modelling approaches leveraging e.g. model-based meta-analysis, target-mediated drug disposition models, and clinical trial simulations.
- Serve as a consultant on client projects by providing a combination of hands-on modelling, as well as project scoping, analysis plan development, results interpretation, reporting and sharing with client teams.
- Broaden their drug development expertise by working with a myriad of companies, molecular modalities, and therapeutic areas.
- Develop their consulting career path by recognizing and seeking opportunities that match their ambition and personal interests.
- Provide project leadership to multiple consultants, supervise project contributions of more junior colleagues and/or act as account leader.
- Support our Business Development teams through maintenance of client relationships and writing of proposals.
- Lead company initiatives (e.g. IT, methodology, efficiency, automation, quality), conduct quality control and quality assurance activities on model codes and reports and support managers in recruitment and coach more junior consultants.
Education, Experience, Training, and Knowledge:
- PhD, MD, PharmD in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.
- A minimum of 7 to 10 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.
- In-depth knowledge of multiple modeling and simulation techniques (e.g. PopPK, PKPD, MBMA, statistical modeling) and multiple TA's.
- Experience in moving compounds through thedifferent phases of development and experience with various elements of clinical development clinical trial design and conduct and regulatory filings.
- Demonstrated skills and experience in pharmacometrics, clinical pharmacology, pharmacokinetics and pharmacodynamics in a project team setting (including leadership roles), with clients as well as internal staff.
- Deep knowledge and experience in a specific therapeutic area, such as oncology, cardiovascular, immunotherapy or pediatric products is of interest.
- Specific expertise with software and methodologies outside of the standard population PK-PD tools is a plus.
- Experience in direct interactions with regulatory agencies is a plus.
Skills & Abilities
- Recognized expertise in modeling and simulation approaches (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, dataset creation, database augmentation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling) - supported by a track record of peer reviewed publications
- Expert in PK/PD and statistical software (e.g., NONMEM, Monolix and MatLab) and programming language(s) (e.g., R, SAS, S-Plus).
- General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is required.
- In-depth modeling skills, ability to translate complex problems into fit-for-purpose models to address them.
- Independent performance of analysis & modeling as well as development of reports.
- Well-developed project planning and management skills -- work plan writing, budgeting, delivery.
- Ability to independently lead project teams and actively mentor others.
- Strong understanding of business strategy and offerings with ability to drive the development of project proposals and contribute to business development efforts.
- Comfortable in a client environment, well versed in communicating and collaborating with client scientists and key decision makers.
- Ability to identify new business development opportunities through client interactions.
- Proven ability to lead company initiatives.
- Excellent writing, editing, verbal communication in English.
- Excellent interpersonal skills.
Certara is a growing company that provides a novel 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.
Learn more about Certara on www.certara.com