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Senior Principal Scientist - Clinical Pharmacology

10+ years
Not Disclosed
10 June 24, 2025
Job Description
Job Type: Full Time Education: Master’s degree /PhD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Summary

Alvotech is hiring a Senior Principal Scientist - Clinical Pharmacology in India for a full-time position. This leadership role offers an excellent opportunity to drive clinical pharmacology strategies and execution for global clinical trials. The ideal candidate will have over 10 years of experience in clinical pharmacology, PKPD analysis, and population modelling, along with strong proficiency in regulatory documentation and global compliance standards such as ICH-GCP.


Key Responsibilities

  • Lead clinical pharmacology activities for assigned global clinical programs and trials.

  • Develop clinical pharmacology strategies, study designs, protocols, and Statistical Analysis Plans (SAPs).

  • Collaborate with biostatisticians on the review of tables, listings, and figures.

  • Ensure adherence to GCP and maintain high-quality standards for Alvotech-sponsored trials.

  • Prepare and review regulatory documents including briefing books and regulatory submissions.

  • Provide statistical consultation to cross-functional clinical teams.

  • Support assay development and validation with internal and external partners.

  • Work independently and in multifunctional teams to deliver project milestones.

  • Travel internationally as required for clinical program activities.


Required Skills & Qualifications

  • Master’s Degree in Clinical Pharmacology or related scientific discipline (PhD preferred).

  • Minimum 10 years of experience in clinical pharmacology or clinical trial management.

  • Expertise in PKPD analysis, population modelling, and simulation methods.

  • Experience with large molecules and biosimilars is highly desirable.

  • Proficiency in technical software: Phoenix, WinNonlin, SAS, R, Monolix, NONMEM.

  • In-depth knowledge of ICH-GCP and international regulatory guidelines.

  • Excellent communication skills—both written and verbal—in English.

  • Strong organizational, analytical, and leadership skills.

  • Demonstrated ability to work collaboratively within cross-functional teams.


Perks & Benefits

  • Work with a globally recognized and fast-growing pharmaceutical leader.

  • Positive, flexible, and collaborative work environment.

  • Opportunities for international travel and exposure to global clinical programs.

  • Comprehensive training and career development programs.

  • Home internet and office equipment support.

  • Supportive and inclusive organizational culture with a strong focus on work-life balance.

  • A clear and well-structured career advancement path.


Company Description

Alvotech is a global biopharmaceutical company committed to improving lives through affordable biologic medicines. With a focus on innovation and excellence, Alvotech drives access to high-quality biosimilars across global markets. Our diverse and inclusive work environment fosters collaboration, creativity, and integrity.


Work Mode

On-site, India (with international travel as required)


Call to Action

If you are an experienced clinical pharmacology leader eager to make a global impact in drug development, apply now to join Alvotech’s mission in transforming access to biologic therapies.