Head of Preclinical Development (PhD, 100%, m/f)
- Job function: Head of Preclinical Development
- Career Level: PhD
- Type: permanent
NBE Therapeutics AG, a rapidly growing Basel-based biotechnology company, is committed to the development of next generation antibody drug conjugates for the treatment of cancer. We are looking for a highly motivated:
In collaboration with research scientists, project management, regulatory and CMC, this position is responsible for the development, execution and refinement of NBE-T's preclinical strategy and reports directly to the Chief Scientific Officer.
· Apply a broad understanding of toxicology, pharmacology, ADME, and knowledge of applicable regulatory guidelines to the design and interpretation of relevant preclinical studies.
· Interpret preclinical pharmacokinetic data to inform human dose projections. Conduct or be accountable for PK/PD modeling activities to estimate efficacious dose and exposure range in humans.
· Write and review nonclinical study documents and regulatory documents; contribute to regulatory submissions.
· Participate in discussions with regulatory agencies to obtain feedback on nonclinical development programs.
· Maintain a current understanding of large molecule translational science literature and methodology, as well as the scientific literature related to the specific drug discovery projects.
· PhD in toxicology, pharmacology, or other biological science and 5-10 years relevant industry experience; strongbackground in preclinical development of antibody-based therapeutics is essential.
· In-depth knowledge of PK/PD, drug metabolism and pharmacology/toxicology.
· Experience in designing, conducting and interpreting nonclinical pharmacodynamics, pharmacokinetics and toxicology studies in various species (incl. NHPs).
· Familiarity with the development and use of relevant bioanalytical assays (ADA, PK).
· Familiarity with the design, development and evaluation of biomarkers.
· Experience with PK/PD model development and human dose projections.
· Proficiency with state-of-the-art PK/PD modeling software (e.g. WinNonlin).
· Familiarity with GLP regulations and regulatory guidelines and experience with writing/compilation of nonclinical sections for various regulatory submission documents.
· Very good command of the English language; German is an asset but not essential.
We are looking for a flexible and motivated team player that likes to be in an environment where everyone’s performance has an impact on the company’s further growth and success. For more information about NBE Therapeutics AG, please visit our website.
We look forward to receiving your application including motivation letter, which you are invited to send to: email@example.com referring to job-opening number ref190211W