AddressWho we are
The opportunity
This Clinical Pharmacology role is part of the broader Quantitative Clinical Pharmacology and Biosimilar Sciences (QPB) team supporting the entire Innovative and Biosimilar Medicines portfolio in Teva’s R&D organization. The Director of Clinical Pharmacology (CP) will represent the CP department at internal (study, project, clinical team) and external meetings (with regulatory authorities, collaborators, and/or vendors) working on innovative medicine products (small and large molecules). You will apply model-based drug development concepts to impact decision making and expected to have experience and relevant training in pharmacokinetics. In this critical role, you will be required to interact with a wide range of functions within Innovative Medicines R&D and collaborate with non-clinical and clinical development, as well as matrix integration with Pharmacometrics and Clinical Operations. Additionally, you will be mentoring junior team members and participate in the CP leadership team. This is a key strategic role requiring extensive leadership skills and technical expertise, which will focus on the CP development strategy in supporting the selection of the right dose, in the right population, including relevant biomarkers and endpoints that will allow to deliver an optimally differentiating CP package to support products development and registration.
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.
How you’ll spend your day
- 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.
Your experience and qualifications
- 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
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.
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