Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) - 2406190600WDescriptionJohnson & Johnson is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) located in Spring House, PA or Raritan, NJ.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 https://www.jnj.com/ .The Therapeutic Area (TA) Clinical Pharmacology (CP) Associate Director role within Clinical Pharmacology & Pharmacometrics (CPP) will apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of simple and complex clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support.The Associate Director will be responsible for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various partners within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics). The CPP leader can independently complete the day to day operations for the clinical pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.Key Responsibilities:
Devise 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.
Translate quantitative knowledge into strategic opportunities with key partners to drive development along the model-informed drug development principles.
Plan, perform, and/or provide oversight forappropriate analyses (e.g., non-compartmental, population and/or modeling 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.
Plan, summarize and interpret the results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
Prepare and deliver scientifically robust and efficient clinical pharmacology strategies for development candidates.
Carry out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
Devise clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches.
Manage and/or supervise operational elements of CPP studies.
Develop key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape.
Define regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
Participate in the evaluation of potential business development opportunities.
Stay abreast of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modelling 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.
Work effectively in a matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
Apply appropriate regulatory (eg: FDA, EMA, PMDA, ICH etc) guidelines in the design of clinical development plans and studies.
Apply relevant technical trainings/findings to daily responsibilities, with focus of opportunistic deliver of value/impact.
Foster a working environment that promotes collaboration, innovation, and creativity.
Assist in process improvement initiatives and SOP development where applicable.
QualificationsEducation:
PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences.
Experience and Skills:
6 years of experience in pharmaceuticals or related fields is required.
Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine 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.
Understanding of the overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process is required.
Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology strategy of the drug development plan is required.
Solid understanding of US, European, and Asian regulatory requirements and guidelines is required.
Good oral and written communication skills, including ability to interpret PK and PKPD results, prepare presentations to communicate findings effectively and influence partners is required.
Strong level of expertise and scientific reputation through multiple publications and presentations is required.
Drug development experience in the therapeutic area of Oncology including understanding of disease, patient population, and treatment paradigm is preferred.
The anticipated base pay range for this position is $135,000 to $232,300.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k).Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year.
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
Holiday pay, including Floating Holidays – up to 13 days per calendar year.
Work, Personal and Family Time - up to 40 hours per calendar year.
Additional information can be found through the link below.For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits .This job posting is anticipated to close on 06/07/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .Primary Location NA-US-Pennsylvania-Spring HouseOther Locations NA-US-New Jersey-RaritanOrganization Janssen Research & Development, LLC (6084)Job Function Pharmacokinetics & PharmacometricsReq ID: 2406190600W