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Senior Principal Scientist - Clinical Pharmacology

10+ years
Not Disclosed
10 June 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 seeking a highly experienced Senior Principal Scientist - Clinical Pharmacology for its India location. This full-time role involves leading clinical pharmacology activities and developing strategic plans to drive innovative clinical programs. You will play a critical role in PKPD analysis, population modelling, and supporting regulatory document preparation, ensuring global standards compliance for biosimilar development. This is a unique opportunity to influence Alvotech’s mission of expanding access to affordable biologics while collaborating in a cross-functional, globally engaged environment.


Key Responsibilities:

  • Lead clinical pharmacology operations for assigned clinical programs.

  • Design and plan clinical trials, ensuring adherence to global regulatory guidelines.

  • Prepare and review regulatory documents including briefing books, protocols, and sections related to clinical pharmacology.

  • Collaborate with biostatisticians on SAP development and mock-up data displays.

  • Provide statistical and pharmacological guidance to clinical teams.

  • Ensure GCP compliance and maintain high-quality standards in clinical trials.

  • Support internal and external resources in assay development and validation.

  • Contribute to cross-functional projects to meet overall development objectives.

  • Facilitate knowledge sharing and ensure alignment with corporate strategies.


Required Skills & Qualifications:

  • Master’s degree in a relevant scientific field (PhD preferred).

  • Minimum 10 years of experience in clinical trials or clinical pharmacology.

  • Proficiency in PKPD analysis, population modelling, and simulation techniques.

  • Experience in large molecules and biosimilar development is highly desirable.

  • Expertise in software tools such as Phoenix, WinNonlin, SAS, R, Monolix, NONMEM.

  • Comprehensive knowledge of ICH-GCP and global regulatory guidelines.

  • Excellent communication, organizational, and leadership skills.

  • Strong team player with cross-functional collaboration capability.

  • Willingness to travel internationally for clinical and departmental activities.


Perks & Benefits:

  • Opportunity to contribute to life-changing biosimilar therapies.

  • Inclusive and collaborative international work culture.

  • Flexible, innovative, and supportive working environment.

  • Clear organizational structure with leadership transparency.

  • Continuous professional training and global career advancement prospects.

  • Balanced work-life approach with home internet and office equipment provided.


Company Description:

Alvotech is a global biopharmaceutical leader specializing in the development and manufacturing of affordable, high-quality biosimilars. With a focus on innovation and patient access, Alvotech fosters an environment of scientific excellence, diversity, and global collaboration to improve healthcare worldwide.


Work Mode:

On-site – India (International travel may be required)


Call to Action:

Ready to transform healthcare through cutting-edge clinical pharmacology? Apply now to join Alvotech’s dynamic team and shape the future of affordable biologics.