Senior Scientist, Clinical Pharmacology & DMPK

Ultragenyx Pharmaceutical; Brisbane (CA); On-site; USD 147,000 - 183,000; Full time

Job summary

A leading company in rare disease medicine is seeking a Senior Scientist in Clinical Pharmacology & DMPK. The role involves driving drug concepts from preclinical studies through clinical development, ensuring quality documentation for regulatory submissions, and collaborating with project teams. Candidates should have a PhD and 5-8 years of industry experience. The position offers a supportive environment focused on professional growth and competitive compensation.

Benefits

Vacation

Holidays

Stock Plans

Fitness Reimbursement

Tuition Sponsorship

Qualifications

• 5-8 years of industry experience in clinical development.
• Proficiency with noncompartmental PK analysis.

Responsibilities

• Serve as a Clinical Pharmacology or DMPK representative on project teams.
• Develop and execute DMPK and clinical pharmacology plans.
• Communicate study results and interpretations effectively.

Skills

Communication

Team Collaboration

Education

PhD in pharmacokinetics

PhD in pharmacology

PhD in pharmaceutical science

Tools

Phoenix WinNonlin

Job description

At Ultragenyx, we fundamentally believe that taking impactful action to care for the needs of patients and our people is always the right thing to do. Our vision is to lead the future of rare disease medicine by challenging the status quo and creating a new model that benefits more patients and caregivers through innovative, accessible treatments. We achieve this by following science, applying rapid development approaches, making medicines at fair prices, and fostering collaboration to reach patients meaningfully.

Our commitment extends to our employees, with a focus on creating a supportive, inclusive environment that promotes learning and growth. We aspire to be an organization where our employees can thrive both professionally and personally.

If you seek to make a meaningful impact, excel in your career, and grow, both professionally and personally, we invite you to join our team.

Position Summary:

Ultra-focused: Work together to fearlessly uncover new possibilities.

As a Senior Scientist in Clinical Pharmacology & DMPK, you will be a self-starter with excellent scientific leadership capabilities. You will be part of an innovative team that efficiently drives the translation of drug concepts from preclinical studies through clinical development and lifecycle management. Your responsibilities include delivering ADME and clinical pharmacology plans and data to advance our pipeline of diverse modalities, contributing to regulatory documents, and representing your team in meetings with project teams and collaborators.

Flex:

This role typically requires onsite work 2-3 days per week, or more depending on business needs. Specific onsite days will be set by the business.

Responsibilities:

• Serve as a Clinical Pharmacology or DMPK representative on project teams.
• Develop and execute DMPK and clinical pharmacology plans from IND stage through clinical development.
• Analyze nonclinical or clinical PK/PD data.
• Communicate study results and interpretations effectively.
• Author sections of reports, protocols, investigator brochures, and regulatory submissions.
• Conduct PK/PD analyses and modeling for dosing strategies.
• Stay current with literature and methodologies related to clinical pharmacology and DMPK.
• Ensure quality documentation for global regulatory submissions.

Requirements:

• PhD or equivalent in pharmacokinetics, pharmacology, or pharmaceutical science.
• 5-8 years of industry experience with understanding of ADME, pharmacokinetics, and clinical pharmacology, including clinical development.
• Proficiency with noncompartmental PK analysis using Phoenix WinNonlin.
• Strong interpersonal, communication, and team collaboration skills.
• Knowledge of bioanalytical methods related to PK/PD/immunogenicity.
• Experience with diverse drug modalities (small molecules, biologics, mRNA therapeutics) preferred.
• Understanding of FDA and ICH guidance documents.

The annual salary range for this full-time position is $147,500 - $182,200 USD, with eligibility for bonuses and incentives. Benefits include vacation, holidays, stock plans, fitness reimbursement, tuition sponsorship, and regional variations.

Ultragenyx is an equal opportunity employer committed to diversity and inclusion. Reasonable accommodations are available for applicants with disabilities or other protected statuses. For accommodations, contact Talent Acquisition at [email].