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.

Main Accountabilities

• 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.

Minimum Qualifications / Experience

• Ph.D. or equivalent, with at least 12+ years of industrial experience in Clinical Pharmacology and/or Pharmacometrics and application of MIDD

Minimum Technical Knowledge and Skills

• 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)

Minimum Non-Technical Competencies and Skills

• 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)

Other Requirements

• Estimated travel of about 5% - 15% of time

Required Skills:

Preferred Skills: