Associate Director Sr Scientist Clinical Pharmacology DMPK
Associate Director Sr Scientist Clinical Pharmacology DMPK
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Job Description
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
As a Senior Scientist in Clinical Pharmacology & DMPK you will be a selfstarter with excellent scientific leadership capabilities. You will be part of an innovative Clinical Pharmacology & DMPK team that efficiently drives the translation of drug concepts from preclinical pharmacology studies through clinical development and lifecycle management. You will be responsible for the delivery of ADME and clinical pharmacology plans and data to help advance a pipeline of diverse modalities for Ultragenyx. You will contribute to the preparation of documents for regulatory agency meetings and will serve as a representative in meetings with project teams and collaborators.
Work Model:
Flex: This role will typically require onsite work 23 days each week or more depending on business needs. In many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Serve as Clinical Pharmacology or DMPK representative on project teams.
- Develop DMPK and clinical pharmacology plans and execute strategies for programs from IND stage through clinical development
- Evaluate and perform handson analysis of nonclinical or clinical PK/PD data
- Ensure timely and accurate communication of study results and interpretation to internal drug development teams
- Author clinical pharmacology and ADME sections of study reports protocols investigator brochures and other regulatory submissions
- Conduct PK/PD analyses and modeling to inform FIH dosing strategies
- Maintain a current understanding of clinical pharmacology and DMPK literature and methodology as well as literature related to specific drug development projects
- Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submissions
Requirements:
- PhD or equivalent degree in pharmacokinetics pharmacology or pharmaceutical science
- Demonstrated understanding of ADME pharmacokinetics and clinical pharmacology with 58 years of related industry experience including clinical development
- Demonstrated proficiency with handson noncompartmental PK analysis and data reporting using Phoenix WinNonlin
- Excellent interpersonal skills and demonstrated ability to represent Clinical Pharmacology and DMPK in a collaborative team environment
- Excellent written and verbal communication skills and ability to explain complex technical information
- Understanding of bioanalytical methods related to PK/PD/immunogenicity
- Experience with diverse drug modalities (e.g. small molecules biologics mRNA therapeutics) is preferred
- Knowledge of relevant FDA and ICH guidance documents #LICS1#LIHybrid
The typical annual salary range for this fulltime position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$147500 $182200 USD
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Required Experience:
Director
Employment Type
Full Time
