Principal Scientist, Pharmacokinetics (PK) & Quantitate Systems Pharmacolog at CSL

, , Switzerland -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Sciences, Pharmacokinetics, Quantitative Systems Pharmacology, Modeling and Simulation, PK/PD, Mechanistic Modeling, Study Design, Data Analysis, GLP Regulations, ICH Guidelines, Cross-Functional Collaboration, Technical Guidance, Mentorship, Regulatory Submissions, Therapeutic Areas, Communication Skills

Industry

Pharmaceutical Manufacturing

Description

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Position Description Summary: 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 CSL’s disease therapeutic areas. Experience across multiple therapeutic areas and modalities is highly desirable. Experience working in multicultural and international teams. Our Benefits We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ 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 world’s 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. We want CSL to reflect the world around us 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. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring! 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 click here. CSL Global Privacy Notice for Job Applicants and Candidates

Responsibilities

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.