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Certara
,
London, Greater London
Associate Director Pharmacometrics
Overview
Job Description
Certara is hiring an Associate Director Pharmacometrics to support our Integrated Drug Development - Quantitative Science Services group. This position will be based in Europe in one of our offices (Paris, Berlin, Amsterdam, Oss, Breda, Krakow, London, Basel) or home based. About our Integrated Drug Development - Quantitative Science Services group We are the largest pharmacometric organization in the world, which enables us to assure that various career pathways are offered which match the ambition and personal interests of our employees! As one of Certara's divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience in working on thousands of 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. Job Summary The Associate Director Pharmacometrics supports client early and late clinical development engagements by providing pharmacometric evaluations that address 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. Responsibilities Conduct modeling analyses to address client's key drug development questions Work as a billable consultant (~80% of "time in the office") on client projects. Consulting is typically done via hands-on modeling. Participate in company initiatives (e.g. IT, methodology, efficiency, automation, quality). Conduct quality control and quality assurance activities on model codes and reports. May supervise project contributions of Associate scientists. Education, Experience, Training, and Knowledge: PhD, MD, PharmD in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields. Strong knowledge in at least 1 M&S technique (e.g. PopPK/PKPD, MBMA, stats) and preferably applied across multiple therapeutic areas. Minimum 3-5 years of industry experience, pharmaceutical industry experience preferred but may be substituted with engineering or related industries. Solid experience in pharmacometrics, clinical pharmacology, pharmacokinetics and phamacodynamics in a project team setting is preferred, whether in academia or industry. Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings is preferred. Know-how and experience in a specific therapeutic area, such as oncology, cardiovascular, immunotherapy or pediatrics. Skills & Abilities Proficient in modeling (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). Proficiency 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 preferred. General modeling skills, ability to translates complex problems into fit-for purpose models to address them. Independent performance of analysis & modeling and development of reports with limited supervision. Comfortable in a client environment, able to communicate with and collaborate with peer scientists. Developing ability to identify new business development opportunities through client interactions. Ability to work across functions to implement company initiatives. Ability to supervise/provide oversight of associate scientist colleagues. Excellent verbal and written communication in English. Excellent interpersonal skills. About Certara 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 us on www.certara.com Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.