The Principal Scientist PK/QSP will lead and manage nonclinical PK/QSP strategies across multiple drug development projects. This role serves as the primary PK/QSP representative on interdisciplinary project teams and provides scientific leadership from early discovery through regulatory submission and market authorization. The Principal Scientist PK/QSP is responsible for the design, adequate budgeting, and monitoring of non-clinical PK/QSP studies conducted internally and externally both in a GLP and non-GLP environment
Main Responsibilities:
Serves as PK/ ADME/QSP representative on cross-functional project teams.
Act as Nonclinical Development representative in Research Project teams.
Acts as PK Study Monitor for external PK studies.
Serves as technical expert for the PK/QSP organization in the application of advanced PK/PD, mechanistic, and disease modeling principles and methodologies,
Performs advanced PK/PD modeling utilizing mechanistic and semi-mechanistic approaches to define the dose-concentration-efficacy/toxicity relationships, formulate various study design scenarios, and outcome prediction, to inform decision making.
Leads study design discussions, study protocols development, including sample size calculations, data analysis plan, and report population PK and PK/PD analysis results to management and review committees.
Provides technical guidance and mentor junior team members to achieve the project objectives.
Actively maintains relationships and collaborate with colleagues within or outside NCD, supports the selection of PK CROs.
Establishes and maintains external collaborations with academic groups active in a variety of ADME/PKPD/QSP areas of research worldwide.
Present integrated PK(QSP assessments to senior management and at project milestone reviews.
Qualifications and Experience Requirements:
PhD in Pharmaceutical Sciences or related subject area with minimum 5+ years of pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation.
Training in PK/PD, modelling and simulation, using industry standard software packages, such as Phoenix WinNonLin, NONMEM, R, etc.
Proven track record in nonclinical PK/QSP assessments and regulatory submissions.
Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements.
Excellent communication, leadership, and cross-functional collaboration skills.
Experience with CSLâs disease therapeutic areas.
Experience across multiple therapeutic areas and modalities is highly desirable.
Experience working in multicultural and international teams.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patientsâ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the worldâs largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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