Senior Director

Job Description Senior Directors in the Pharmacometrics group within the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on a continuous basis by evaluating and incorporating M&S tools in decision making and drive pipeline impact. Senior Directors provide strategic pharmacometrics leadership and oversight, both supervising the work of other scientists and a portfolio of projects and leading pharmacometrics efforts on drug development programs. Senior Directors are expected to have or be developing expertise in several areas, including: Leverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas, modalities and stages of drug discovery/development to independently provide day-to-day coaching/guidance to individual contributors Responsible for achieving results via others on major program drivers by implementing novel quantitative approaches (translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses) that seek to improve cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programs Serving as an expert Pharmacometrics representative for QP2 on drug/vaccine development teams Framing critical drug development questions for optimizing model-based development Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings Overseeing a group of scientists (in a scientific and/or supervisory role) Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities May provide functional representation on committees, task forces or initiatives spanning beyond QP2 Provides review and scientific input on reports and regulatory documents at all stages of development Manages and initiates external collaborations with world leading experts to develop new methodologies Fosters collaboration within QP2 to achieve results, remove barriers on portfolio or scientific priorities Senior Directorsin the Pharmacometrics group within QP2 are skilled pharmacometricians, with a strong, integrated understanding of the strategic elements of drug discovery and development, and lead the combined efforts of QP2 and the wider Translational Medicine (TMED) organization. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Senior Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2 and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams. Required: (a Ph.D. or equivalent degree with at least 10 years of experience) OR (a PharmD or equivalent degree with at least 12 years of experience) OR (an MS or equivalent degree with at least 14 years of experience), where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia. Educational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field. Deep expertise in pharmacometrics (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling) with ability to understand how MIDD can drive portfolio and regulatory decisions. Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills required Drug development expertise agnostic of therapeutic area, including a record of both internal and external impact in driving model-informed drug development strategies across programs Proficiency in state-of-the-art modeling approaches (for e.g., NONMEM, Bayesian estimation, MBMA, CTS, QSP) Demonstrated ability to apply appropriate FDA, EMA and other/ICH guidelines in the application of predictive model-based approaches in the design of development plans and study design Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings. Preferred: An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry. Extensive experience in developing quantitative strategies for impacting pipeline decisions Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics. Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists Emerging leader in the field of Pharmacometrics with a track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning. Communication Skills: demonstrates ability to effectively present complex data, development plans and strategies to various audiences in both verbal and written form, steer and influence interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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