- Develop clinical pharmacology strategies and drive execution across development pipeline
- Serve as clinical pharmacology subject matter expert and an advisor to senior management
- Represent Clinical Pharmacology on project teams and cross-functional initiatives and in global health authority meetings
- Lead model-informed drug development across development pipeline
- Perform business development due diligence assessments
- Mentor junior-level scientists and may supervise a direct report(s)
- Evaluate and perform hands-on analysis of clinical PK/PD data
- Conduct PK/PD modeling to inform dosing strategies for development programs
- Ensure timely and accurate communication of study results and interpretation to internal drug development teams
- Author clinical pharmacology sections of NDA and/or BLA filings, clinical study reports, protocols, investigator brochures, regulatory responses, and other submissions
- Contribute to clinical pharmacology literature and maintain a current understanding of scientific literature relevant to development programs
- Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submission
- PhD or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or relevant science with 12+ years of industry experience.
- Demonstrated understanding of translational PK and clinical pharmacology with industry experience in clinical development.
- Experience in drug development of diverse modalities (e.g., small molecules, biologics, nucleic acid therapeutics, and gene therapies) for rare diseases is preferred. Ability to rapidly master new scientific areas is essential.
- Demonstrated proficiency with hands-on PK noncompartmental analysis and data reporting using Phoenix WinNonlin
- Demonstrated experience with exposure-response analysis, concentration QTc analysis, mechanistic PK/PD modeling, and population PK modeling is desired.
- Capable of independently authoring and delivering ADME and Clinical Pharmacology sections of regulatory submissions
- 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
- Clear and influential communicator and collaborator, capable of establishing strong cross-functional partnerships with internal and external stakeholders.
- Understanding of bioanalytical measurement techniques and method development for drug candidates spanning diverse modalities and therapeutic areas. #LI-CK1 #LI-Hybrid #LI-Remote
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Senior Director, Clinical Pharmacology - Brisbane, United States - Ultragenyx
2 weeks ago
Description
Why Join Us?Be a hero for our rare disease patients
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.
Position Summary:
ultraimpact - Make a difference for those who need it most
The Senior Director of Clinical Pharmacology will develop clinical pharmacology plans and deliver data packages to help advance the clinical development of a diverse pipeline of therapeutic modalities (e.g., small molecules, biologics, nucleic acid therapeutics, and gene therapies). The Sr. Director will be responsible for clinical pharmacology sections of submissions to regulatory agencies and will serve as a representative in meetings with partners, collaborators, clinical investigators, and global health authorities. The Sr. Director will proactively collaborate across the company, contributing to the R&D strategy, developing the clinical pharmacology strategy, and executing these strategies within the Translational Sciences organization.
Work Model:
Remote: Officially documented as working full-time from home, with travel to Ultragenyxs offices or other locations on occasion as needed.
Or
Flex: This role 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:
Requirements:
The typical annual salary range for this full-time 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.
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:* Generous vacation time and public holidays observed by the company* Volunteer days* Long term incentive and Employee stock purchase plans or equivalent offerings* Employee wellbeing benefits* Fitness reimbursement* Tuition sponsoring* Professional development plans* Benefits vary by region and country
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
See our CCPA Employee and Applicant Privacy Notice.See our Privacy Policy.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: .PDN-9bb84301-1c21-433f-a70b-5276f5215748
