Teva Senior Director Clinical Pharmacology 

United States, Pennsylvania, East Bradford Township 

36928543

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

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 NCA and pharmacometric modeling preferred.

Functional Knowledge:

⦁ Excellent understanding of drug development process.
⦁ Proven leadership in the transition of discovery programs into clinical development and submissions.
⦁ In-depth knowledge and expertise in developing small and large molecule therapeutics.

Company/Industry Related Knowledge:

• Experience in change management
• Global/international experience, including ability to lead intercultural regionally based programs teams

We offer a competitive benefits package, including:
•Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
•Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
•Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, and holiday.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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