Senior Director Clinical Pharmacology

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The holder of this position is expected to drive high quality of Clinical Pharmacology deliverables, lead change aimed at improving the efficiency of studies and to foster and implement innovative state-of-art methodologies in clinical pharmacology/early phase clinical research.  By focusing on these areas the following achievements are expected: clinical timelines will be accelerated, cost of clinical studies will be reduced and entry into Phase-2/3 studies will be done with robust comprehensive data in healthy subjects and/or patients. To be successful the candidate must demonstrate strong leadership and collaboration within the group and with other GEC functions and R&D groups.  

 

The Sr. Director spends most of her/his time doing independent technical work, leading tasks and supporting projects. The Sr. Dir CP can mentor junior team member, he/she can lead multiple projects, often will serve as a clinical lead as part of the Clinical Development Team (CDT) and being an expert in CP contributes to the overall quantitative clinical pharmacology strategy and other cross functional/department initiatives as necessary. 

How you’ll spend your day

Travel Requirements:  
•    Ability to travel with overnight stays, as required

 

Essential Duties & Responsibilities:

 

• Sr.Dir CP is responsible for the CP/early clinical development deliverables for their programs teams:
  
  • Support the clinical pharmacology strategy across their specific programs
  • Generation of CP information and integration with up-to-date regulatory and scientific resources to inform decision-making and bring value to the programs.
  • Planning, direction, and interpretation of clinical pharmacology studies defined in the Clinical Development Plan
  • Participates in planning, writing and leading clinical pharmacology related modules of regulatory documents and application
• Supports company clinical development strategy by:
  • Assessing impact of new and evolving relevant operational, scientific, and regulatory strategies and industry trends  
  • Keeping abreast with relevant regulations and scientific literature.
  • Promotes the value of ClinPharm by sharing professional knowledge with external stakeholders
  • Developing consistent CP processes.
• Responsible for financial planning/forecasting and budget management of their program.
• Represents CP with internal and external stakeholders, and at relevant governances. 
• Initiates, develops, leads and participates in company initiatives to meet cross functional drug development objectives and other continuous improvement to achieve innovation in drug development, cost –reduction, time-savings, efficiency and quality business objectives.
• Represents clinical pharmacology and defend clinical pharmacology strategy and study results and interpretation at regulatory interactions.
• Follows Teva Safety, Health, and Environmental policies and procedures

 

This position is a hybrid role based out of our West Chester, PA office. Candidates within commuting distance to our Parsippany, NJ office will also be considered.

Your experience and qualifications

Requirements:

 

• PhD in Clinical pharmacology, pharmacology, pharmaceutical sciences, life sciences/chemistry/biology or related fields and relevant experience of a minimum of 12 years in the pharmaceutical industry (preferred), academia or regulatory agency such as the FDA. A post pectoral fellowship can be counted towards relevant experience.
• MD and a minimum 12 years of relevant experience in the pharmaceutical industry (preferred)  or post completion of degree in research or medical practice or with regulatory authorities such as the FDA.

 

Preferred:

 

• Experience/training in population PK/PD analyses.
• Experience in more than one therapeutic area and in early development
• Proven track record of delivering results, including filing of INDs and NDAs.
• Experience with software used for NC