Senior Principal Scientist – Clinical Pharmacology
Location: India
Job Type: Full-time
Application Deadline: June 29, 2025
Alvotech is hiring a Senior Principal Scientist to lead initiatives in clinical pharmacology, playing a key role in designing and executing clinical programs that support the development of biosimilars and innovative biologics. This is an exceptional opportunity for an accomplished scientist to influence regulatory and clinical strategies while advancing global healthcare access.
Scope & Responsibilities:
Lead clinical pharmacology activities across assigned clinical programs and trials.
Drive strategy development for clinical pharmacology, including protocol design, briefing books, and planning of regulatory documents.
Collaborate with biostatisticians to develop Statistical Analysis Plans (SAPs), and review statistical outputs including tables, listings, and figures.
Provide scientific and statistical consultation to cross-functional clinical teams for effective decision-making.
Author and revise relevant sections of regulatory submissions and other deliverables.
Ensure compliance with global standards and GCP regulations across all clinical pharmacology functions.
Oversee assay development and validation activities in coordination with internal and external stakeholders.
Independently manage project timelines, priorities, and deliverables, while functioning effectively within multidisciplinary teams.
Job Requirements:
Master’s degree in a related discipline is required; PhD in Clinical Pharmacology or related field with relevant experience is preferred.
Minimum of 10 years of experience in clinical pharmacology or clinical trials.
Expertise in pharmacokinetics/pharmacodynamics (PKPD), population modeling, and simulation methodologies.
Familiarity with large molecule development and biosimilar programs is desirable.
Strong command of relevant tools and software, including Phoenix, WinNonlin, SAS, R, Monolix, and NONMEM.
Excellent communication skills with the ability to produce high-quality documentation.
Sound organizational, leadership, and team collaboration skills.
Strong knowledge of ICH-GCP and global regulatory guidelines.
Willingness to travel internationally as required to support global operations.
What We Offer:
A challenging and meaningful role with direct impact on global patient access to biologics.
Opportunity to be part of a growing, global organization with a collaborative and inclusive work culture.
A dynamic and forward-thinking team environment that values scientific innovation.
Support for ongoing learning, internal career development, and training programs.
Flexible work arrangements, home internet, and office equipment support.
Balanced workload and a well-structured organization supporting personal and professional well-being.
Estimated Salary: ₹40 – ₹50 LPA, depending on experience and qualifications.
Gujarat :
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