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Director of Pharmacometrics

4 months ago


West Chester, United States Teva Pharmaceutical Industries Full time

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

Responsible for the design and implementation of PMX strategy on the program level; the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with TS colleagues and other R&D partners.

Essential Duties & Responsibilities:

* Lead design and implementation of the PMX strategy and other advanced Model Informed Drug Discovery and Development approaches (within and/or across programs) to enable quantitative decision making thorough the drug development cycles
* Manage and perform pharmacometric analyses done internally and/or by external vendors using a variety of tools and approaches. Integrate, interpret, and report results to project teams and other customers.
* Proactively contribute into key pre-clinical, clinical, and regulatory documents including; clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and BLA/NDA's within agreed timelines, and meeting all regulatory requirements.
* Ensure constructive collaboration within drug development teams and with other internal partners (e.g. DMPK, Regulatory Affairs, Clinical Development, and Biostatistics).
* Monitor timelines, objectives and, budgets. Ensure accuracy of project and activity progress. Assure rapid and effective communication of high-quality data and results to project teams.
* Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance). Initiate training / study sessions within Teva's Clinical Pharmacology & Pharmacometrics and for other line functions. Act as technical subject matter expert in key clinical pharmacology / DMPK / pharmacometric related area.
* Attend meetings with internal and external parties including stakeholders, investigators, outside experts, and health authorities

Travel Requirements:

* Ability to travel with overnight stays, as required

Position will be based out of West Chester, PA and candidate should be able to work onsite. Open to candidates working out of the Parsippany, NJ office as well. For the right candidate, we may consider remote/hybrid.

Your experience and qualifications

Requirements:

* PhD in clinical Pharmacology/Pharmaceutical sciences/pharmacology/Statistics/engineering with academic training in Pharmacometrics
* Minimum 10 years of hands on industry experience in Pharmacometrics

Preference:

* Experience in more than one therapeutic area and early development

Technical Knowledge:

* Strong quantitative skills and expertise (e.g. experience in mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations)
* Excellent knowledge of drug development process.
* Communication and presentation skills.

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.

Make a difference with Teva Pharmaceuticals

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.