Director Pharmacometrics

West Chester, United States, Pennsylvania, 19380
Job Id:
59973
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.
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 through 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 to 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.
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:

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 holidays.
Life and Disability Protection:
Company paid Life and Disability insurance.

The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an 'at-will position' and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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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