Scope of Work
The Clinical Pharmacology Lead will be part of the Clinical Science team and is responsible for developing and implementing the Clinical Pharmacology Plan and Modeling-Informed Drug Development strategies for early stage drug development programs, using state-of-the-art quantitative methodologies to integrate knowledge of biology, pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), modelling and simulation.
The core responsibilities are:
· Help develop clinical pharmacology plan for early stage drug development programs, including both small and large molecules.
· Act as clinical pharmacology subject matter expert on multidisciplinary teams working closely with clinicians, biostatisticians, and clinical operations colleagues to design, conduct and report clinical trials from first-in-human to proof-of-concept; responsible for clinical pharmacology components including PK, PK/PD, food effect (oral compound), drug-drug interaction, QTc, and immunogenicity (biologics).
· Collaborate with preclinical scientists and critically evaluate translational models developed from preclinical data to ensure adequate confidence in prediction of human PK and efficacious dose projections.
· Provide scientific justification for optimal human starting dose and dose escalation schemes for first-in-human protocols based on all available preclinical information including toxicology, efficacy models, physicochemical and biochemical characterization.
· Work closely with clinical assay specialists to ensure that appropriate and validated bioanalytical assays are available on time for measuring drug concentration and anti-drug antibodies (for biologics) for clinical studies.
· Lead the conduct of PK data analysis and the development of computational models from PK/PD, safety and efficacy data collected in early stage clinical trials to support key program decision-making.
· Present clinical pharmacology results to internal and external stakeholders.
· Author clinical pharmacology components of clinical documents including protocols, investigator brochures, clinical development plans, study reports and regulatory modules; author scientific publications.
Required background and experience:
· Advanced degree (Ph.D., Pharm.D.) or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, Systems Biology or other related disciplines.
· Additional expertise in PK data analysis and PKPD model development is a plus.
· At least 5 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics.
· Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
· Excellent verbal and written communication skills.
· Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.
· Previous experience in leading clinical pharmacology development plans, from first in human to Phase 3.
· Previous experience in writing pharmacology sections of regulatory documents (e.g. Briefing Books), and experience in regulatory submissions and interactions
· Flexibility to adapt to changing priorities and deadlines
· Ability to work independently and collaboratively, as required, in a matrix environment
· Team player, collaborative attitude, able to make a positive impact in the team
If you are attracted by this exciting opportunity and the prospects of joining a motivated international team operating on a global level, please send your CV and motivation letter mentioning the position “Clinical Pharmacology Lead” as the subject by email to: firstname.lastname@example.org.