Overview
A top mid-sized biopharma company out of the Boston area is hiring for a Director of Clinical Pharmacology. This position is can provide remote flexibility. This company is global biotechnology company with multiple commercialized drug products in the U.S and a great reputation in the space. This company operates in a few different therapeutic areas and requires a senior member to join their clinical pharmacology team and lead strategic decision making to develop their clinical pipeline.
You will be acting as a SME in clinical pharmacology working with internal and external teams. You will be using the model informed drug development paradigm to facilitate drug development. As well as providing input to all applicable clinical development plans, protocols, and clinical study reports. You will work on regulatory submissions and represent Clinical Pharmacology at meetings with regulatory agencies. This individual will also help develop strategy to streamline processes in the Clinical Pharmacology group.
What would you be doing?
- Serve as a Clinical Pharmacology SME for early development and late stage clinical projects.
- 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 (experience reviewing datasets in R or NONMEM is a plus) to strategize and predict exposure-response as well as dosing.
- Working closely with multiple different cross functional teams such as PMX 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
- At least 8+ years in the biotechnology or pharmaceutical industry
- 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 (nice to have)
- Excellent communication skills
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