Sr. Distinguished Scientist Clin Pharm

Johnson & Johnson•San Diego, CA

About The Position

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 Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Pharmacokinetics & Pharmacometrics Job Category: Scientific/Technology All Job Posting Locations: Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Cambridge, Massachusetts, United States of America, 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: Johnson & Johnson -- About Innovative Medicine Our 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): US - Requisition Number: R-051910 Switzerland - Requisition Number: R-056533 Belgium - Requisition Number: R-056538 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Objective of Position The scientific advisor is responsible for providing scientific advice on global drug development strategies for both small and large molecule compounds in early and late development consistent with principles of Model Informed Drug Development (MIDD) and Clinical Pharmacology considerations. In this role, the scientific advisor represents CPP at QSTEPS (i.e., Quantitative Sciences Technical Excellence and Program Strategy (QSTEPS) committee) as a core member and provides consultations for study designs, dose selection, and drug development strategy across the JJIM portfolio. The position leads the organization in planning successful MIDD plans, fostering application of MIDD through implementation of PK, PK/PD, ER, QSP, and MBMA approaches to identify and answer key clinical questions and devise optimized development strategies. As part of the disease modeling and innovation team, the scientific advisor assists in the implementation of new methodologies and/or new focus areas for CPP keeping abreast of innovation methodology within clinical pharmacology and pharmacometrics field, in alignment with our focus therapeutic areas.

Requirements

Ph.D. or equivalent, with at least 12+ years of industrial experience in Clinical Pharmacology and/or Pharmacometrics and application of MIDD
Knowledge of drug development of small molecules, monoclonal antibodies and other new modalities (e.g., ADCs, cell-based therapies, siRNA, etc).
Deep expertise in advanced concepts of clinical pharmacology, pharmacokinetics, pharmacometrics and study design.
Experience in development of drug candidates in early and late-stage development across key therapeutic areas (oncology, immunology, neuroscience) including application of MIDD
Experience in interaction with Regulatory Authorities globally
Experience in the application of PK, PK/PD and other modeling approaches (e.g., QSP, MBMA)
Good written and oral communication skills (communication)
Ability to build and enhance working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently in a timely manner (planning and organizing)
Adding value to the organization assuming responsibility and accountability for successfully completing assignments or tasks (delivery of results)
Actively identifying new areas for learning and application to the job (continuous learning)
Good sense of cultural sensitivity and diversity (cultural diversity)
Good project management skills (program management)
Self-motivated with the ability to work independently with minimal supervision (personal accountability)

Responsibilities

Represent CPP at QSTEPS and CPP reviews; represent CPP at other governance/review committees, as required.
Ensure appropriate MIDD planning for projects and in support of our focused disease areas.
Work with CPP colleagues globally, cross-functionally with other functions in JJIM, and/or externally, as needed, to identify, evaluate, recommend, and implement innovative scientific approaches for CPP colleagues to broaden the understanding of and impact on drug development for small and large molecules.
Provide scientific advice related to the MIDD approaches including translational pharmacology approaches for compounds in development and to Clinical Pharmacology development plans.
Assist with implementation of new methodologies and/or new focus areas for CPP.
Train, guide and mentor scientists within the global CPP organization to realize their full potential.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits