Certara is hiring a Senior Director Clinical Pharmacology to support our Integrated Drug Development division. This position will support our global clinical pharmacology team and can be home-based, office based or a combination in Europe.
Certara is hiring a Sr. Director Clinical Pharmacology to support our Integrated Drug Development team! This position can be located anywhere in the US. About Certara Strategic Consulting Certara Strategic Consulting is the largest pharmacometric organization in the world and assures that various career pathways are offered to match the ambition and personal interests of our employees! We are a division of Certara and 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 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.
As the Sr. Director, Clinical Pharmacology, you will support the design, execution, and management of high quality clinical pharmacology, DMPK, and pharmacometrics studies. This position plays a pivotal role in assisting our Directors and Sr. Directors as they provide strategic clinical pharmacology guidance on drug development. Our team includes thought leaders who are among the most well respected in the growing industry of complex biologic and immunotherapy platforms! If working alongside smart and driven colleagues sounds exciting to you, we want you on our team! Responsibilities
· Supports client projects through early translational to late development for clinical pharmacology and quantitative analyses.
· Collaborates with internal and client teams on regulatory, clinical development, clinical pharmacology, pharmacometric and another drug development issues. · Assist Project Leaders in writing and compiling reports and other documents summarizing advice both internally and for clients.
· Perform non-compartmental analyses (NCA), creation of tables, figures and listings (TFL), authoring of pharmacokinetic (PK) sections in Clinical Study Report, Regulatory Modules, PK analysis plans
· Conduct data exploration and preliminary PK and PK/PD modeling in support of drug development decisions
· Work collaboratively with Project Leader and clients to ensure an adequate clinical pharmacology package and study design; IND/First in human enabling packages, back translation of Clinical PK/ADME data and PK-PD relationships.
· Exploring/contribution in insourcing and outsourcing certain aspects of pharmacometric work, including data management and routine pharmacometric analysis. · Co/authoring peer-reviewed manuscripts and publications.
Skills & Abilities · PhD or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.
· 8-10 years of experience, in small or large drug development companies · Knowledge of translational and clinical pharmacology plans and preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
· Experienced in design of clinical pharmacology components of clinical development plans and optimal application of pharmacometric approaches to support decision making.
· Understanding and/or application of a broad range of clinical pharmacology and quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, S-Plus/R and other PK/PD analysis software.
· Excellent written, verbal and inter-personal communications skills.
· Must be able to work well with a team in a multidisciplinary environment.
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. The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
· Financial – competitive pay, incentives, retirement plans, income security programs · Health and Wellness – comprehensive benefit package, wellness programs, healthy lifestyle office environments · Work/Life –unlimited paid time off and an employee assistance program · Growth & Development – performance driven environment
· Community Impact – volunteering opportunities, matching gifts, charitable contributions 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.
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.