Teva Director Clinical Pharmacology 

United States, Pennsylvania, East Bradford Township 

465289027

This is a site-based role in our West Chester office or Parsippany, NJ where you will be spending 3 days in the office and 2 days working from home.

• Lead the Clinical Pharmacology (CP) strategy, planning, direction, execution and data interpretation of CP studies (Phase 1a, 1b, special population, device bridging, ethnic bridging, DDIs etc) with scientific rigor and innovative approaches.
• Support all CP related aspects of late stage clinical studies.
• Optimize dosing regimens, study designs, and contributing to the Quantitative Clinical Pharmacology strategy on assigned projects.
• Integrate preclinical information to progress molecules from nomination to early clinical development stages.
• Deliver a CP plan at the project level.
• Work in a matrix with Pharmacometrics colleagues to define first–in-human dose range and characterize exposure-response relationships to guide drug development.
• Critically analyze and interpret PK and PD data.
• Participate in protocol design, writing and clinical study report writing taking full accountability for CP studies.
• Contribute to the evaluation of new business development opportunities.
• Participate in planning, writing and leading CP related modules of regulatory documents and applications.
• Represent CP and defend CP strategy and study results and interpretation at regulatory interactions.
• Present internally or outside the organization.
• Participate in the CP leadership team to shape the departmental strategy and mentor junior members of the CP group.
• Remain up to date on clinical pharmacology, MIDD, new analytical approaches and regulatory guidance while being active as a member of the scientific community.

• MD or PhD in pharmaceutical sciences/clinical pharmacology or other relevant life sciences or PharmD with relevant preclinical and clinical pharmacology background
• Minimum 10 years of experience in the clinical pharmacology area with discipline lead experience
• Minimum 5 years of experience in contributing to regulatory filings in the USA and Europe
• Minimum of 5 years of PK, PK/PD analysis and simulation hands-on experience
• Minimum of 2 years of managing or mentoring of junior staff
• Prior experience with immunology or neurology is a plus
• Excellent communication and influencing track record at the team level and in interactions with management
• Ability to work in a multidisciplinary team environment
• Experience in therapeutic areas of interest (neurology, immunology, immune-oncology, respiratory, pain)
• Experience with preclinical and clinical PK of large and small molecules

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