Senior Principal Scientist driving nonclinical safety strategies for Degrader - Antibody Conjugate programs at Orum Therapeutics. Overseeing nonclinical toxicology studies and collaborating with cross - functional teams.
About the role
- Principal Scientist in Pharmacometrics developing modeling and simulation activities for drug research at Johnson & Johnson. Collaborating across departments for data analysis and quality control processes.
Responsibilities
- Preparing R programming scripts to generate non-linear mixed effect modelling (NONMEM) analysis input dataset(s) for PK, PK/PD or Exposure Response analysis.
- Generating Analysis Dataset Non-Compartmental Analysis (ADNCA) input datasets and associated Data Transfer Agreements and metadata.
- QC NONMEM or ADNCA input dataset(s) generated by another PM support colleague.
- Generating e-submission package for NONMEM analysis, ensuring correct structure and format.
- Interacting with other departments and external vendors for data collection and training.
- Piloting generation of the first draft AI Authored data specification.
- Driving internal process improvements in dataset creation and QC procedures.
Requirements
- A minimum of a Bachelor’s degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or a related field with 8+ years of pharmaceutical development experience; or a Master's degree with 6+ years of pharmaceutical development experience; or a PhD with 4+ years of pharmaceutical development experience is required.
- Expertise with R programming language and R function creation is required.
- A fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts is required.
- Good understanding of regulatory requirements and eCTD is required.
- Good understanding of AI driven approaches within data programming is required.
- Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM is required.
- Excellent written and oral communication skills with strong attention to detail are required.
- Ability to build and improve working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships) is required.
- Ability to collaborate in a diverse global environment is required.
- Self-motivation with the ability to work independently with minimal direction is required.
- Preferred: R Shiny programming experience is preferred.
- Prior knowledge with ADNCA and ADPPK dataset standards is preferred.
- Knowledge of principles of non-linear mixed effect modeling is preferred.
- Prior experience with pharmacometric analysis QC would be an asset.
- Experience within oncology and immunology is an asset.
Benefits
- medical, dental, vision, life insurance, short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- Vacation –120 hours per calendar year
- Sick time - 40 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
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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