Global Clinical Pharmacology Manager (d/f/m)

May 03, 2021

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to give to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career within clinical development!

Job purpose:

Representation of global line function (GLF) on cross-functional Global Project Team; he/she is the core member of the GPT and takes the leadership role within represented line function. Responsible for the PK (Pharmacokinetics) and PD (Pharmacodynamics) components of development plans, study protocols, reports, project summaries, within agreed timeframes and in accordance with regulatory requirements. Responsible for Clinical Pharmacology components of regulatory submissions. Contribute to the development and implementation of innovative clinical strategies supporting a streamlined global development of Sandoz Biosimilars.

Your responsibilities:

•Develop clinical pharmacology, PK and PD strategy for Biosimilar development programs; contribute to the strategy for immunogenicity assessment
•Contribute to elaborating strategies that may complement or substitute for clinical outcomes to streamline Biosimilar clinical programs
•Provide expert Clinical Pharmacology counsel to the IPT (International Project Team), ICT (International Clinical Team), and other cross functional teams in the context of root cause analyses for specific issues
•Ensure quality of the clinical pharmacology plans, project specifications, study protocols, reports, summaries and publications
•Responsible for crafting and analyzing the PK and PD components of clinical trials in all phases of development
•Provide the PK/PD sections of clinical protocols, clinical study reports, Investigator’s Brochures, Health Authority Briefing Books, IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) applications, CTD (Common Technical Document) summaries, and any other relevant document for Health Authority submissions
•Establish efficient collaboration with key partner functions within and outside BCD (Biopharmaceuticals Clinical Development) (notably Biostatistics, Bioanalytics, Preclinical, Clinical Development, Regulatory Affairs, Technical Development and Analytical Characterization)
•Ensure representation as needed for all health authority interactions
•Develop and support external contacts (investigators, academic and regulatory community, partners in collaborations); maintain a contact with the broader Novartis Clinical Pharmacology network

Minimum Requirements

What you’ll bring to the role:

What you’ll bring to the role:
•Ph.D. in clinical pharmacology, pharmacokinetics, drug metabolism or a related subject area, PharmD or equivalent with biological background or equivalent training on the job, M.D.
•Minimum 5-7 years’ experience in the area of preclinical and clinical pharmacology and pharmacokinetics or related field in a pharmaceutical based company, with a 3-4 years’ experience as a project team representative within a LF in industry
•Expert knowledge in preclinical and clinical drug development, especially for biologics drugs
•Demonstrated proficiency using analysis tools (e.g. Phoenix, SAS, NONMEM, R)
•Familiar with respective health authority, GCP and ICH requirements paired with current knowledge of scientific and regulatory areas affecting Biologics issues worldwide
•Demonstrated leadership in a matrix organization; team work in a environment
•Excellent written and verbal communication skills, with presentation skills and strong critical thinking and prioritization skills

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
BioPharma SZ
Holzkirchen (near Munich)
Research & Development
Full Time
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Global Clinical Pharmacology Manager (d/f/m)

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