- Apply advanced pharmacometric methodologies to support drug discovery, development, and regulatory decisions.
- Conduct model-based analyses, including population pharmacokinetics, pharmacokinetic-pharmacodynamic modeling, exposure-response analyses, quantitative systems pharmacology, and physiological-based pharmacokinetic modeling.
- Develop and implement customized clinical pharmacology and DMPK plans.
- Write, review, and edit regulatory documents (e.g., INDs, NDAs, IBs) and respond to regulatory inquiries.
- Ensure timely and accurate execution of clinical pharmacology studies and programs within agreed timelines and budgets.
- Lead the writing of scientific publications, including abstracts, posters, oral presentations, and manuscripts.
- Manage relationships with CROs to ensure compliance with protocols, quality standards, and timelines.
- Ph.D. or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, Chemistry, or a related field, with a minimum of 10 years of industry experience.
- Extensive experience in pharmacometrics analysis with hands-on expertise in study design, data analysis, and modeling-simulation.
- Proficiency in modeling software (e.g., Phoenix WinNonlin, NONMEM, R, SAS).
- Excellent communication and teamwork skills to effectively collaborate with external and internal teams.
- Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements.
- Experience in managing external resources, including CROs and consultants.
- Ability to handle multiple tasks in a fast-paced environment while maintaining a positive attitude and strong work ethic.
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Director, DMPK
3 weeks ago
Evommune, Inc. Palo Alto, United StatesJob Description · Job DescriptionABOUT EVOMMUNE · Evommune, Inc., a Palo Alto based biotech company, is creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive di ...
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Associate Director of DMPK
5 days ago
EPM Scientific San Francisco, United StatesI am partnered with a growing biotech company located in San Francisco who is looking for an Associate Director of DMPK to join their team This company currently has 8 candidates in their preclinical pipeline and 2 clinical candidates across metabolic, neuro, ophthalmology, and c ...
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Director, DMPK
3 weeks ago
Eli Lilly and Company San Francisco, United States Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...
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Associate Director, DMPK
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Third Rock Ventures San Francisco, United StatesThe Position: · Are you ready to take the helm of discovery efforts in our DMPK group at Maze? As an Associate Director, you'll be at the forefront of driving our mission forward, supporting discovery projects from hit-to-lead (H2L) through investigational new drug (IND) phases. ...
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Associate Director, DMPK
2 days ago
Oric Pharmaceuticals, Inc. San Francisco, United StatesWe are seeking a highly motivated Senior Principal Scientist/Associate Director specialized in characterizing the in vitro and in vivo ADME/PK properties of small molecule lead compounds and drug candidates. This person will work on ORIC drug discovery and development project tea ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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IDEAYA Biosciences South San Francisco, United States Full timeIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates ext ...
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Director, Dmpk
3 weeks ago
Evommune, Inc. Palo Alto, United States**ABOUT EVOMMUNE** · This position is currently expected to be in the office 2 days a week with the option of working remotely 3 days a week. Currently, most Evommune employees attend the office on Tuesdays and Wednesdays (at a minimum). The position reports to the Executive Dire ...
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Recruits Lab (We're hiring) San Francisco, United StatesAre you ready to pioneer groundbreaking precision medicine therapies in the field of oncology? Our client, a leading clinical-stage precision medicine oncology company, is seeking a visionary · Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to join their ...
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IDEAYA Biosciences, Inc. San Francisco, United StatesIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates ext ...
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Senior Director, Clinical Pharmacology
3 weeks 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 ...
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Senior Director, Clinical Pharmacology
2 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 ...
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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 ...
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Sr. Manager/Associate Director, CMC Development
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Frontier Medicines South San Francisco, United StatesJoin Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at our South San Francisco office. · As a crucial member of our team, reporting directly to the Head of CMC, you'll play an integral role in advancing our s ...
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Associate Director, Process Chemistry
2 days ago
Internetwork Expert Inc South San Francisco, United StatesFrontier Medicines is seeking a highly motivated individual for a newly created Associate Director role in Process Chemistry in Frontier's South San Francisco office. The successful candidate will lead internal and external resources to develop scalable manufacturing processes fo ...
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Frontier Medicines South San Francisco, United StatesJob Description · Job DescriptionJoin Frontier Medicines on an exciting journey as our newest Principal Scientist/Associate Director, CMC Development located at our South San Francisco office. · As a crucial member of our team, reporting directly to the Head of CMC, you'll play ...
Director of DMPK - South San Francisco, United States - EPM Scientific
Description
Overview:
We are seeking a highly skilled professional to provide comprehensive guidance on clinical pharmacology initiatives that support drug discovery and development. This role involves authoring clinical protocols, analyzing data (exposure, efficacy, safety), and contributing to the development and registration of new products.
Key Responsibilities:
Requirements:
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