SciPro has partnered with a global top 5 pharmaceutical company who is hiring for a Director of Clinical Pharmacology to join their Clinical Pharmacology & Pharmacometrics team. My client has over 40 commercialized drug products and is expanding their Global Clinical pharmacology team requiring hiring in this division.
The goal of this position is to develop drugs for their diverse and growing pipeline, and determine the right dose for the target patient and using model-informed drug research and development (MIDD) paradigm. In this position, you will have the opportunity to represent clinical PKPD on early development programs and provide guidance on lead modalities and programs to various teams working to determine the right target, molecule, dose, patient population and strategies. You will work closely with pharmacometrics teams to review study protocols (Phase I – III), advise on various regulatory documents (INDs, IBs, CDTs), and collaborate with regulatory agencies.
What would you be doing?
Represent clinical PKPD on early development programs.
Provide guidance on lead modalities and programs to various teams working to determine the right target, molecule, dose, patient population and strategies.
Apply knowledge in PKPD and relevant analysis (reviewing datasets in R or NONMEM) to strategize and predict exposure-response.
Working closely with multiple different cross functional teams such as pharmacometrics to develop study protocols (Phase I – III).
Advise on various regulatory documents (INDs, IBs, CDTs).
Collaborate with various regulatory agencies (FDA, EMA, PMDA).
Requirements:
PhD required in pharmaceutical sciences, pharmacology, or related field
Experience with clinical pharmacology and PKPD modeling, exposure-response or dose selection
Experience with clinical PK data and data analysis (Phase I-IV)
Experience in NONMEM and/or R?
Excellent communication skills