Ultragenyx is seeking a Scientist II with the passion and creativity to develop great medicines for rare and ultra-rare diseases.  The individual will be a self-starter who is seeking to be part of an innovative DMPK team that efficiently drives the translation of drug concepts from preclinical pharmacology studies to the clinic.  As a DMPK project representative, the incumbent will be responsible for the support of DMPK studies and data to help advance a pipeline of diverse modalities for Ultragenyx.

Work Model: 

• Flex: This is a Flex role, which will typically require onsite work 2-3 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:

• Serves as DMPK functional lead in project teams to provide guidance on DMPK-related activities.
• Evaluate and perform hands-on analysis of nonclinical pharmacokinetic data.
• Ensure timely and accurate communication of study results and interpretation.
• Author DMPK sections of study reports, protocols, investigator brochures, and other regulatory submissions.
• Work as a bench scientist to perform in vitro studies to characterize PK/PD properties of drug candidates.
• Maintain a current understanding of DMPK literature and methodology, as well as the scientific literature related to specific drug development projects.
• Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submissions.
• Participate in the preparation of conference abstracts and manuscripts for publication.

Requirements:

• A minimum of 2 years industry related or post-doctoral experience
• Experience with nucleic acids and/or gene therapy preferred.
• Demonstrated proficiency with hands-on PK NCA analysis and data reporting using Phoenix WinNonlin (preferred).
• Experience with cell culture and hepatocytes.
• Strong analytical and problem-solving skills
• Excellent interpersonal skills and ability to represent DMPK in a collaborative team environment.
• Highly organized and detail-oriented with strong record keeping and data management skills
• Excellent written and verbal communication skills.

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping/bending / kneeling.
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights.
• Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.
• Certain tasks may require use of a respirator; medical clearance will be required in advance.#LI-CK1 #LI-Onsite