Alvotech is looking to hire a Senior Principal Scientist to lead and innovate within our clinical pharmacology team. This role offers the opportunity to make a significant impact on our clinical programs and contribute to the development of groundbreaking therapies.
We seek a highly experienced scientist with a deep understanding of clinical pharmacology, PKPD analysis, and population modelling. Your expertise will be crucial in designing and planning clinical trials, developing regulatory documents, and ensuring compliance with global standards.
At Alvotech, you will play a key role in our mission to improve global access to affordable medicines. You will be part of a dynamic team dedicated to scientific excellence and innovation, enjoying a collaborative work environment, opportunities for professional growth, and the chance to contribute to transformative therapies.
Please note that international travel may be required to support departmental activities.
Scope & Responsibilities:
- Lead clinical pharmacology activities for assigned clinical programs/trials.
- Develop and revise relevant sections of regulatory documents and deliverables.
- Develop the clinical pharmacology strategy, briefing book, study design, and protocol development. Collaborate with biostatisticians on Statistical Analysis Plans (SAPs) and review mock-up displays for tables, listings, and figures.
- Provide statistical consultation to clinical teams and support decision-making processes.
- Ensure GCP compliance and high-quality standards for Alvotech's sponsored clinical trials.
- Support internal and external resources in assay development and validation.
- Work independently and as part of a multifunctional team to achieve project deliverables.
Job Requirements:
- Master's Degree in a related discipline (PhD in Clinical Pharmacology or related discipline with relevant experience is desirable).
- Minimum 10 years of experience in clinical trials or clinical pharmacology.
- Expertise in PKPD analysis, population modelling, and simulation.
- Experience with large molecules and biosimilars is desired.
- Excellent written and verbal communication skills.
- Proficiency in technical software such as Phoenix, WinNonlin, SAS, R, Monolix, and NONMEM.
- Strong organizational and management skills.
- Deep knowledge of ICH-GCP and regulatory guidelines.
- Proven ability to collaborate effectively within cross-functional teams.
- Strong interpersonal skills, including the ability to build team spirit and communicate openly.
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What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Internet at home for full-time employees.
Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.