Director Clinical Pharmacology

1 week ago

West Chester, Pennsylvania, United States Tevapharm Full time
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West Chester, United States, Pennsylvania, 19380

Job Id:

54853
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


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.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees.

Use the following link to search and apply:
Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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.

Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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