Job Summary:
Alvotech is seeking a Senior Principal Scientist – Clinical Pharmacology to lead innovative clinical pharmacology programs in Stockholm, Sweden. This pivotal role involves shaping clinical development strategies, designing clinical trials, and performing PKPD analyses and population modelling. The ideal candidate will bring at least 10 years of clinical pharmacology experience and a passion for biosimilar development to help expand affordable biologic therapies globally.
Key Responsibilities:
Lead clinical pharmacology activities across assigned clinical programs.
Design, develop, and refine regulatory documents, including briefing books, study protocols, and strategy documents.
Collaborate with biostatistics to develop Statistical Analysis Plans (SAPs) and review data outputs.
Provide statistical consultation to guide clinical and scientific decisions.
Ensure strict compliance with ICH-GCP guidelines and high-quality trial execution.
Support assay development and validation through coordination with internal/external partners.
Work independently and within cross-functional teams to meet program deliverables.
Required Skills & Qualifications:
Master’s Degree in Clinical Pharmacology or related field (PhD preferred).
Minimum 10 years of clinical pharmacology or clinical trial experience.
Expertise in PKPD analysis, population modelling, and simulation techniques.
Hands-on experience with large molecules and biosimilars is advantageous.
Proficiency in Phoenix, WinNonlin, SAS, R, Monolix, NONMEM.
Deep understanding of ICH-GCP and regulatory expectations.
Strong project management, organizational, and leadership skills.
Excellent written and verbal communication abilities.
Effective teamwork and interpersonal skills for cross-functional collaboration.
Perks & Benefits:
Opportunity to contribute to life-changing biosimilar products.
Fast-paced and collaborative international environment.
Diverse and inclusive company culture fostering innovation.
Well-defined organizational structure supporting personal development.
Professional growth via internal training and global assignments.
Positive, flexible workplace culture.
Work-life balance with supportive policies and benefits.
Company Description:
Alvotech is a global biopharmaceutical company dedicated to the development and manufacturing of affordable biosimilar medicines. Renowned for scientific innovation and compliance, Alvotech fosters an international, diverse, and collaborative environment that prioritizes excellence in biopharma research and development.
Work Mode:
On-site – Stockholm, Sweden
(International travel required for departmental needs)
Call to Action:
Ready to lead the future of clinical pharmacology and biosimilars? Apply now and be a part of Alvotech’s mission to make high-quality biologics accessible worldwide.
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