Johnson & Johnson companies are equal opportunity employers.
ASSOC DIR CLIN PHARMA/PHARMACOKINETICS-9892140505
Description
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc., is recruiting for an Associate Director, Clinical Pharmacology/Pharmacokinetics located in Fort Washington, PA.
McNeil Consumer Healthcare markets a broad range of well-known and trusted OTC products around the globe. McNeil is most widely recognized for the complete line of TYLENOL® acetaminophen products, the leading brand of pain reliever/fever reducer in the adult and pediatric categories. The TYLENOL® product line consists of products across a variety of pain categories including: arthritis pain, pain with accompanying sleeplessness and symptoms of cold and flu. Other McNeil brands include BENADRYL®, ZYRTEC® and ZYRTEC-D® allergy medicines; IMODIUM® anti-diarrheal products; MOTRIN® IB; SUDAFED® and SUDAFED PE® nasal decongestants.
The Associate Director, Clinical Pharmacology/Pharmacokinetics will represent the clinical research group on company project teams, design and oversee studies, evaluate new products and technologies, and author pharmacokinetic sections of clinical and regulatory documents for marketing applications, scientific white papers, and citizen petitions, as needed. Will proactively partner with functional & cross-functional (eg. R&D, regulatory, marketing) groups in business strategic planning providing clinical pharmacology strategies/ direction to the business. The successful candidate will ensure that clinical pharmacology requirements of markets are understood and incorporated upfront from product concept development. Partner with marketing and R&D organization to develop robust and innovative claims supported with sound science. Will work with global/ regional/ local colleagues to identify core processes and support required to ensure projects can be aggressively implemented with greatest commercial impact. Work closely to monitor new regulations with respect to clinical pharmacology and work with internal teams to implement processes and procedures to remain compliant. Help shape the regulatory environment to bring new opportunities for the business. Ensure development plans and training programs are devised and maintained on an ongoing basis. Ensure personnel and Contractors are adequately trained on business acumen and regulatory knowledge, capabilities & competencies.
Qualifications
A minimum of a PhD in Pharmacokinetics (or equivalent in the pharmaceutical sciences) and a minimum of 6 years of combined industry, postdoctoral and/or academic experience with hands-on experience designing, directing, and interpreting data from pharmacokinetic, pharmacodynamic, and standard bioavailability/bioequivalence studies is required.
Hands-on experience with analyzing pharmacokinetic data using applicable software programs (i.e., WinNonlin, NONMEM) is required.
Demonstrated experience as a Direct Sponsor oversight of contract research organizations, including commercial Phase 1 Units and bioanalytical labs is required.
Current training on Good Clinical Practices, a working knowledge of clinical operational processes and applicable ICH guidelines is required.
Experience with placing and conducting pharmacokinetic and bioequivalence studies in various global regions (i.e., China, Brazil, Canada, and Eastern Europe) is preferred.
Excellent communication skills with ability to build and maintain critical working partnerships with various customers is required.
Demonstrated Project Management experience is preferred.
Demonstrated People Management experience is preferred.
Demonstrated ability to work in a highly-matrix, team-oriented environment is required.
Experience in working with external companies and alliance partners, and in managing successful research collaborations is preferred.
Up to 15% travel is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)
Job Function: Clinical Research non-MD
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
ASSOC DIR CLIN PHARMA/PHARMACOKINETICS-9892140505
Description
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc., is recruiting for an Associate Director, Clinical Pharmacology/Pharmacokinetics located in Fort Washington, PA.
McNeil Consumer Healthcare markets a broad range of well-known and trusted OTC products around the globe. McNeil is most widely recognized for the complete line of TYLENOL® acetaminophen products, the leading brand of pain reliever/fever reducer in the adult and pediatric categories. The TYLENOL® product line consists of products across a variety of pain categories including: arthritis pain, pain with accompanying sleeplessness and symptoms of cold and flu. Other McNeil brands include BENADRYL®, ZYRTEC® and ZYRTEC-D® allergy medicines; IMODIUM® anti-diarrheal products; MOTRIN® IB; SUDAFED® and SUDAFED PE® nasal decongestants.
The Associate Director, Clinical Pharmacology/Pharmacokinetics will represent the clinical research group on company project teams, design and oversee studies, evaluate new products and technologies, and author pharmacokinetic sections of clinical and regulatory documents for marketing applications, scientific white papers, and citizen petitions, as needed. Will proactively partner with functional & cross-functional (eg. R&D, regulatory, marketing) groups in business strategic planning providing clinical pharmacology strategies/ direction to the business. The successful candidate will ensure that clinical pharmacology requirements of markets are understood and incorporated upfront from product concept development. Partner with marketing and R&D organization to develop robust and innovative claims supported with sound science. Will work with global/ regional/ local colleagues to identify core processes and support required to ensure projects can be aggressively implemented with greatest commercial impact. Work closely to monitor new regulations with respect to clinical pharmacology and work with internal teams to implement processes and procedures to remain compliant. Help shape the regulatory environment to bring new opportunities for the business. Ensure development plans and training programs are devised and maintained on an ongoing basis. Ensure personnel and Contractors are adequately trained on business acumen and regulatory knowledge, capabilities & competencies.
Qualifications
A minimum of a PhD in Pharmacokinetics (or equivalent in the pharmaceutical sciences) and a minimum of 6 years of combined industry, postdoctoral and/or academic experience with hands-on experience designing, directing, and interpreting data from pharmacokinetic, pharmacodynamic, and standard bioavailability/bioequivalence studies is required.
Hands-on experience with analyzing pharmacokinetic data using applicable software programs (i.e., WinNonlin, NONMEM) is required.
Demonstrated experience as a Direct Sponsor oversight of contract research organizations, including commercial Phase 1 Units and bioanalytical labs is required.
Current training on Good Clinical Practices, a working knowledge of clinical operational processes and applicable ICH guidelines is required.
Experience with placing and conducting pharmacokinetic and bioequivalence studies in various global regions (i.e., China, Brazil, Canada, and Eastern Europe) is preferred.
Excellent communication skills with ability to build and maintain critical working partnerships with various customers is required.
Demonstrated Project Management experience is preferred.
Demonstrated People Management experience is preferred.
Demonstrated ability to work in a highly-matrix, team-oriented environment is required.
Experience in working with external companies and alliance partners, and in managing successful research collaborations is preferred.
Up to 15% travel is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)
Job Function: Clinical Research non-MD
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement