Scientist II / Senior Scientist, Clinical Pharmacology & DMPK

Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: May 3, 2021

Job Description:

Scientist II / Senior Scientist, Clinical Pharmacology & DMPK

Novato, CA or Brisbane, CA /

Ultragenyx Pharmacology & Toxicology /

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. During the COVID-19 Outbreak,we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time ourapproachwill includevideo discussions, interviews, andonboarding.

Position Summary

ultra impact Make a difference for those who need it most

As the Scientist II / Senior Scientist, Clinical Pharmacology & DMPK, you will develop great medicines for rare and ultra-rare diseases. You will be a self-starter 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 to the clinic.

You will report to the Executive Director of Clinical Pharmacology & DMPK in the Pharmacology & Toxicology group. You will contribute to the growth of an innovative department where scientists utilize analytical technologies and sophisticated models to inform key drug development decisions. You will be responsible for the delivery of clinical pharmacology plans and data to help advance a pipeline of diverse modalities for Ultragenyx. You will be responsible for the preparation of documents for regulatory agency meetings and will serve as a representative in meetings with partners, collaborators, and clinical investigators. You will proactively collaborate across the company, contributing to the R&D strategy, developing the PK/PD strategy, and executing these strategies within the Translational Sciences organization. This is an individual contributor role. This role can be based in Novato, CA or Brisbane, CA.

Responsibilities including, but not limited to:
Serve as Clinical Pharmacology and/or DMPK representative on project teams Contribute to clinical pharmacology and/or DMPK strategy and execution for development programs Evaluate and perform hands-on analysis of 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 clinical study reports, protocols, investigator brochures, and other regulatory submissions Conduct PK/PD modeling to inform dosing strategies for development programs Maintain a current understanding of clinical pharmacology 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
Requirements:
Level Commiserate with skills and experience. Degree in pharmacokinetics, pharmacology or pharmaceutical science SCIENTIST II: PhD with 4+ years of industry experience or MS with 10+ years of experience SENIOR SCIENTIST: PhD with 5+ years of industry experience or MS with 12+ years of experience Demonstrated understanding of ADME and clinical pharmacology with industry experience in preclinical and clinical stage drug development. Demonstrated proficiency with hands-on PK NCA analysis and data reporting using Phoenix WinNonlin Demonstrated experience with exposure response analysis, mechanistic PK/PD modeling, and population PK modeling is desired. PBPK modeling experience is a plus Experience authoring Clinical Pharmacology and ADME sections of regulatory submissions Experience in drug development of diverse modalities (e.g., small molecules, biologics, mRNA therapeutics) for rare diseases is preferred. Ability to rapidly master new scientific areas is essential. Understanding of bioanalytical techniques and methods for measuring drug levels and anti-drug antibody responses Experience working as a PI with external CROs with timely delivery of clear and accurate study reports Strong knowledge of drug development and FDA and ICH guidance documents Travel: approximately 5% #LI-CV1
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contactTalent Acquisitionby calling:(415) 483-8800or byemailingus at talentacquisition@ultragenyx.com . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to:talentacquisition@ultragenyx.com .

Keywords: Ultragenyx Pharmaceutical, Novato , Scientist II / Senior Scientist, Clinical Pharmacology & DMPK, Other , Novato, California