Director, Clinical Pharmacology

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Pharmacokinetics & Pharmacometrics Job Category: People Leader All Job Posting Locations: La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Director, Clinical Pharmacology to be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or La Jolla, CA. Purpose: The Clinical Pharmacology (CP) Director role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology studies and/or clinical pharmacology components of clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to studies and programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. The Director CP Leader is responsible and accountable for developing and/or overseeing compound specific Clinical Pharmacology strategy for the development of a compound including innovative approaches and leads the regulatory strategy for clinical pharmacology. As the CP Leader on the Compound Development Teams (CDT), the Director works in collaboration with various partners within the team and within CPP (e.g., Pharmacometrics) and provides recommendations that impact the drug development decisions for a program in addition to independently completing the day to day operations for the clinical pharmacology aspects of one or more programs within a disease area and provide management directly or indirectly to junior CPP leaders. The Director CP leader advocates for innovative strategies in support of the portfolio may contribute to the strategic direction of CPP department. The Director manages colleagues and provides oversights and guidance to their projects. You will be responsible for:Planning, completing and/or overseeing the clinical pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development. Translating quantitative knowledge into strategic opportunities with key partners to drive development along the model-informed drug development principles and advocate for innovative strategies. Planning, completing, interpreting and/or overseeing appropriate analyses (e.g., non-compartmental, population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design and overall drug development strategy. Regulatory input for clinical pharmacology informing strategy, regulatory interactions, labeling and clinical use. Planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates. May be accountable for more than one program within a DAS/TA directly or indirectly. Introducing new approaches to problem-solving, process enhancements, and improvement of efficiencies. Represent CPP in cross-functional teams, initiatives, or in CPP review/governance meetings. Managing a team of CPP colleagues. Carrying out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles. Planning, conducting and/or providing oversight of PK and PK/PD analyses and reporting. Clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches, consistent with regulatory guidelines. Managing and/or supervising operational elements of CPP studies. Developing key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape. Defining regulatory strategy for CPP and providing oversight of CP contributions to regulatory documents including IBs, IND’s, briefing books, submission packages, responses to health authority questions, and other regulatory documents. Representing CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings). Participating in the evaluation of potential business development opportunities and provide recommendations. Contributing to the knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department. Influencing external scientific and/or regulatory environment by establishing strong interactions with opinion leaders beyond J&J R&D and developing external collaborations with relevant professional organizations or consortiums. Developing expertise in relevant TA including understanding of pathophysiology including relevant pathway, patient population, competitive landscape, relevant endpoints. Developing relationships and influencing partners (e.g., TA, regulatory, and other colleagues). Accountability for CP deliverables in accordance with timelines and overall project goals. Qualifications/RequirementsEducation: A PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences is required. Experience and Skills:10+ years of experience in the pharmaceutical industry is required. Expert knowledge and understanding of PK, PD, PK-PD, and/or Translational Medicine and their applications in model informed drug development (MIDD) is required. Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab) is required. Detailed understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process is required. Drug development experience in one or multiple therapeutic areas i