17 days old

Associate Director Pharmacometrician

West Chester, PA 19380
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description

Position Summary:
 
  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.  Ability to travel with overnight stays, as required

Essential Duties & Responsibilities:

1. 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
2. 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.
3. 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.
4. Ensure constructive collaboration within drug development teams and with other internal partners (e.g. DMPK, Regulatory Affairs, Clinical Development, and Biostatistics).
5. 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.
6. Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance). Initiate training / study sessions within Tevas Clinical Pharmacology & Pharmacometrics and for other line functions. Act as technical    subject matter expert in key clinical pharmacology / DMPK / pharmacometric related area.
7. Attend meetings with internal and external parties including stakeholders, investigators, outside experts, and health authorities

Qualifications

Position Requirements

Education Required: PhD in Clinical Pharmacology/Pharmaceutical sciences/pharmacology/life sciences/engineering with academic training in Pharmacometrics

Experience Required: 5+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics. For those with less experience, we can fill this as a Sr. Manager level. 

Experience Preferred: Experience in more than one therapeutic area and early development

Specialized or Technical Knowledge Licenses, Certifications needed:

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

Functional Knowledge: 
Company/Industry Related Knowledge: Experience in change management
Global/international experience, including ability to manage intercultural regionally based teams and fluent English skills (oral and written)

Function
Research & Development
Sub Function
Biometrics
Reports To
Already Working @TEVA?

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Categories

Posted: 2019-11-21 Expires: 2019-12-21

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director Pharmacometrician

Teva Pharmaceuticals
West Chester, PA 19380

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