PaloAltoRecruiter Since 2001
the smart solution for Palo Alto jobs

Senior Director, DMPK

Company: Jazz Pharma
Location: Palo Alto
Posted on: October 16, 2020

Job Description:

Job DescriptionOverview: Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs. We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals. Responsibilities: Provide leadership in design, implementation, oversight, analysis and reporting of nonclinical DMPK programs to support small and large molecule drug development including health authority required studies through registration and post-marketing Essential Job Functions: Job Responsibilities This position has varying responsibilities relating to nonclinical and clinical drug development, which include but are not limited to: * Establishing the overall strategic direction for the assessment of Drug Metabolism and Pharmacokinetic aspects of drug products consistent with the company's and research & development organization's goals. * Manage internal and external relationships and resources to enable DMPK characterization of drug candidates at all stages of development. * Planning, preparing and reviewing drug development plans and regulatory filings. This involves determining the scope, protocol design study planning & oversight, data review / analysis / interpretation, and reporting for all DMPK studies implemented to support nonclinical assessment and development. * Driving human dose projection/modeling to support clinical trial design as well as contributing to clinical pharmacology trial design regarding prediction of DDI potential * Selection and management of CROs performing non-GLP and GLP nonclinical studies. Initiate and manage contracts, coordinate activities with contract laboratories and academic partners * Contribute to Early Development departmental processes such as SOP's and templates * Ensure a high quality of work and compliance to appropriate regulatory guidances are followed, including the Good Laboratory Practice (GLP) regulations, ICH, and other regional guidance documents for DMPK assessment of biopharmaceutical molecules. * Represent Jazz in interactions with regulatory agencies and respond to regulatory inquires related to nonclinical content. Responsibilities would also include describing results of these studies in various regulatory documents (INDs, NDAs, IBs, etc.) * Participation on cross functional teams as an Early Development representative to ensure proper integration of these activities into overall project plans * Partner with and provide subject matter expertise to key internal constituencies (regulatory, Quality, Clinical, CMC and formulations, Drug safety, Medical affairs) and their external contractors or collaborators. * Participate in the evaluation of potential in-licensing candidates. Serve as early development sciences representative on teams evaluating candidates for in-licensing or risk sharing opportunities * 10% to 20% Travel Required Minimum Requirements * PhD in pharmacology or relevant discipline. * Extensive knowledge and demonstrated expertise in DMPK and bioanalytical sciences to support nonclinical and clinical stage programs * 5-10 years of related experience in the pharmaceutical or biotechnology industry, demonstrating a broad and proven understanding of drug development. * Thorough working knowledge of FDA and ICH guidance documents * Ability to work effectively independently and in teams, with peers, and with senior management to move projects forward. * Proven ability to manage CRO's and consultants * Excellent written and oral communication skills * Ability to think critically and solve problems * Ability to navigate and be successful in a fast-paced, highly-matrixed work environment * Embody and model Jazz Pharmaceuticals core values (integrity, collaboration, passion, pursuit of excellence and innovation) Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Keywords: Jazz Pharma, Palo Alto , Senior Director, DMPK, Executive , Palo Alto, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Search Engineering Manager - Winters, CA
Description: Job DescriptionJoin Hired and find your dream job as a Search Engineering Manager at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. (more...)
Company: Hired
Location: Winters
Posted on: 10/26/2020

Engineering Manager - Rio Vista, CA
Description: Job DescriptionJoin Hired and find your dream job as a Engineering Manager at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. (more...)
Company: Hired
Location: Rio Vista
Posted on: 10/26/2020

Senior Director of Institutional Culture, Climate & Community Engagement
Description: Department Description br br The Office for Health Equity, Diversity and Inclusion HEDI is responsible for reporting, consulting, coaching, and training on diversity, equity, and inclusion for the (more...)
Company: University of California - Davis Medical Centers
Location: Sacramento
Posted on: 10/26/2020


Search Engineering Manager
Description: Join Hired and find your dream job as a Search Engineering Manager at one of 10,000 companies looking for candidates just like you.Companies on Hired apply to you, not the other way around. You'll receive (more...)
Company: Hired
Location: Esparto
Posted on: 10/26/2020

Search Engineering Manager - Woodbridge, CA
Description: Job DescriptionJoin Hired and find your dream job as a Search Engineering Manager at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. (more...)
Company: Hired
Location: Woodbridge
Posted on: 10/26/2020

Engineering Manager - Capay, CA
Description: Job DescriptionJoin Hired and find your dream job as a Engineering Manager at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. (more...)
Company: Hired
Location: Capay
Posted on: 10/26/2020

Search Engineering Manager - Wilton, CA
Description: Job DescriptionJoin Hired and find your dream job as a Search Engineering Manager at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. (more...)
Company: Hired
Location: Wilton
Posted on: 10/26/2020

Search Engineering Manager - Walnut Grove, CA
Description: Job DescriptionJoin Hired and find your dream job as a Search Engineering Manager at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. (more...)
Company: Hired
Location: Walnut Grove
Posted on: 10/26/2020

Engineering Manager - Birds Landing, CA
Description: Job DescriptionJoin Hired and find your dream job as a Engineering Manager at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. (more...)
Company: Hired
Location: Birds Landing
Posted on: 10/26/2020

Search Engineering Manager
Description: Join Hired and find your dream job as a Search Engineering Manager at one of 10,000 companies looking for candidates just like you.Companies on Hired apply to you, not the other way around. You'll receive (more...)
Company: Hired
Location: Galt
Posted on: 10/26/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Palo Alto RSS job feeds