Director Clinical Pharmacology

Who we are

The opportunity

The Director of Clinical Pharmacology (Dir CP) has overall responsibility for clinical pharmacology strategy of assigned projects; ultimately ensuring maximal alignment of relevant aspects of the label with the TPP.  The Dir CP ensures generation and continuous integration of all available clinical pharmacology (PK, PD, PK/PD) information with up-to-date regulatory and scientific resources to inform decision-making and bring value to the projects. The Dir CP is responsible for the planning, direction/execution, and interpretation of clinical pharmacology studies in accordance with Teva strategy and priorities, leading the cross-functional study team. The role includes, but is not limited to, interaction with pharmacometricians, clinical pharmacology trial managers and clinical/project team members and any other relevant matters for this role.

The Director spends most of her/his time doing independent technical work, leading tasks and supporting projects. The Dir CP can supervise 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. 

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

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.

How you’ll spend your day

• Supports the entire portfolio of Teva Specialty programs/products across multiple therapeutic areas and all phases of clinical development from a clinical pharmacology perspective (from first in man through post-approval), translating relevant Target Product Profile (TPP) attributes into clinical studies/evaluations required to achieve the target label.
• Ensures the generation and continuous integration of all available clinical pharmacology-related information (clinical PK, PD, PK/PD) with up-to-date regulatory and scientific resources to inform decision-making, proactively identifying risks, and ensuring decisions are made at the appropriate levels and with the appropriate cross-functional input.
• Lead the CP strategy, planning, direction, execution and data interpretation of CP studies (e.g. Phase 1a, 1b, special populations, device bridging, ethnic bridging, DDIs) with scientific rigor and innovative approaches.
• Accountable for the planning, direction, and interpretation of clinical pharmacology studies designed to investigate the safety/tolerability, PK and PD of the compound/product:
  • Leads design of, and participates in protocol and clinical study report writing, taking full accountability for clinical pharmacology/Phase 1 studies
  • As a clinical leader of the study, Dir CP implements relevant assessments to facilitate further clinical development and increase probability of success
  • Together with the Trial Manager, ensures that clinical pharmacology studies are run in accordance with set budget and timelines and in accordance of relevant SOPs
  • Responsible for the analysis and interpretation of PK results generated in the study, in collaboration with other functions  
  • Leads presentation of study design and results to internal and external governance bodies
• Works in matrix with pharmacometrics colleagues to define first in human dose range and characterize exposure-response relationships to guide drug development
• Integrates preclinical information to progress molecules from nomination to early clinical development stages
• Support all clinical pharmacology related aspects of late stage clinical studies.
• Participates in planning, writing and leading clinical pharmacology related modules of regulatory documents and applications
• 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

Your experience and qualifications

Required: Any combination of the below requirements will be considered

• PhD in Clinical pharmacology, pharmacology, pharmaceutical sciences, life sciences/chemistry/biology or related fields and relevant experience of and a minimum of 10 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 of 10 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.
• Masters in Clinical pharmacology, pharmacology, pharmaceutical sciences,  life sciences/chemistry/biology or related fields and relevant experience of >14 years in the industry  (preferred) or with regulatory authorities such as the FDA 
• Pharm D  Relevant experience of a minimum of 14 years in the industry, academia or with health authorities such as the FDA 

Preference:

• Experience/training in population PK/PD analyses.
• Experience in more than one therapeutic area and in early development

Functional Knowledge:    

• Good understanding of drug development process.
• Excellent understanding of PK/Clinical Pharmacology concepts.
• Good knowledge of relevant regulatory guidelines

Company/Industry Related Knowledge:  

• Experience in therapeutic areas of interest preferred.
• Experience with biologics a plus.

Enjoy a more rewarding choice

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. 

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.  
 
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. 
 
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