- 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
-
Senior Director, Clinical Pharmacology
5 days ago
Ultragenyx Pharmaceuticals Inc. Brisbane, United StatesPosition 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 modalitie ...
-
Senior Director, Clinical Pharmacology
1 week ago
Ultragenyx Brisbane, United StatesWhy 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 ...
-
Senior Director, Clinical Pharmacology
3 days ago
Maze Therapeutics South San Francisco, United StatesThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
-
Senior Director, Clinical Pharmacology
1 week ago
Ultragenyx Brisbane, United StatesWhy 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 diseas ...
-
Senior Director, Clinical Pharmacology
5 days ago
BioSpace South San Francisco, United StatesJob Details · The Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmac ...
-
Senior Director, Clinical Pharmacology
2 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
-
Senior Director, Clinical Pharmacology
1 week ago
Maze Therapeutics South San Francisco, United StatesJob Description · Job DescriptionThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Directo ...
-
Senior Director, Clinical Pharmacology
1 week ago
Maze Therapeutics South San Francisco, United StatesJob Description · Job DescriptionThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Directo ...
-
Senior Director, Clinical Pharmacology
3 minutes ago
Maze Therapeutics South San Francisco, United StatesThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
-
Senior Director, Clinical Pharmacology
4 days ago
BioSpace, Inc. South San Francisco, United StatesJob Details · The Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharm ...
-
Clinical Pharmacology, Director
5 days ago
89bio, Inc. San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically e ...
-
Senior Director, Clinical Pharmacology
2 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
-
Clinical Pharmacology, Director
3 days ago
89bio San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically ...
-
Clinical Pharmacology, Director
1 week ago
89bio San Francisco, CA, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically ...
-
Alumis Inc South San Francisco, United States Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change t ...
-
BioSpace South San Francisco, United StatesJob Details · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamen ...
-
Alumis Inc South San Francisco, United StatesAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change t ...
-
Structure Therapeutics South San Francisco, United StatesJob Description · Job DescriptionSalary: · POSITION SUMMARY · The Senior Director, Clinical Pharmacology and Pharmacometrics will work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pip ...
-
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
-
Director, Clinical Pharmacology
5 days ago
BeiGene San Mateo, United States**_General Description:_**+ The Director, Clinical Pharmacology will be responsible for developing and executing clinical pharmacology and pharmacometric strategies for novel small molecules and biologics assets in the company portfolio. She/He will provide clinical pharmacology ...
Senior Director, Clinical Pharmacology - Brisbane, United States - Ultragenyx Pharmaceuticals Inc.
Description
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 Ultragenyx's offices or other locations on occasion as needed.
OrFlex:
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:
