- Lead and develop the Quantitative Pharmacology team to provide strategic direction and technical oversight of M&S activities and pharmacometrics analyses spanning Discovery, IND-enabling, and Clinical Development phases.
- Construct translational PK/PD models and establish exposure-response relationships to inform target validation efforts and dose selection decisions; mentor team members performing these activities.
- Select and manage pharmacometrics vendors conducting population PK/PD and exposure-response analyses in support of regulatory submissions for late-clinical stage programs.
- Lead Pharmacology Technical Teams in the IND-enabling and clinical development stage.
- Serve on the Development Sciences Leadership Team; set Function and Organizational goals.
- Establish and maintain productive relationships with key partners within the organization, including Discovery Sciences, Translational PK, Clinical Pharmacology, Translational Medicine, Clinical Development, and Regulatory to advance projects to key decisions and achieve development milestones.
- Recruit and develop talent in the QP group; manage internal and external resources effectively to achieve organizational goals.
- Analyze, interpret, summarize and communicate data to internal project teams, senior management, global health authorities, and strategic partners.
- Contribute to authoring and reviewing nonclinical and clinical sections of regulatory filings and interact with global health authorities.
- PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, Engineering, or related scientific discipline, with 10+ years of relevant biotech/biopharmaceutical experience.
- Established expertise constructing mathematical models to describe drug disposition and pharmacodynamic response to investigate preclinical and clinical PK/PD relationships using standard pharmacometrics software (e.g., NONMEM, R).
- Demonstrated success building and leading Modeling & Simulation/Pharmacometrics Groups to support advancement of drug candidates through development milestones.
- Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results.
- Ability to work effectively and collaboratively on cross-functional project teams.
- Excellent oral, presentation, and written communication skills.
- Experience with regulatory interactions and submissions (NDA, ANDA, BLA).
-
Director, Quantitative Pharmacology
2 weeks ago
Amgen South San Francisco, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collabor ...
-
Director, Quantitative Pharmacology
2 weeks ago
BioSpace South San Francisco, United StatesJob Details · HOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global col ...
-
Director, Quantitative Pharmacology
3 days ago
Amgen Inc. South San Francisco, United StatesJOB ID: R LOCATION: US - California - South San Francisco WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: May. 10, 2024 CATEGORY: Scientific SALARY RANGE: 191,600.00 USD - 236,280.00 USD · HOW MIGHT YOU DEFY IMAGINATION? · If you feel like you're part of something bigger, ...
-
Director, Quantitative Pharmacology
2 weeks ago
Amgen South San Francisco, United States Full timeHOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who ...
-
Merck San Francisco, United States**Job Description** · **Role and Responsibilities:** · We are seeking an experienced talented scientist to join the **Quantitative Pharmacology and** **Pharmacometrics -** **Immune/Oncology** **(QP2-IO)** team in the role of Director. QP2-IO team is part of the Global Clinical De ...
-
Director, Quantitative Pharmacology
6 days ago
Amgen San Francisco, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collabor ...
-
Director of DMPK
3 weeks ago
EPM Scientific South San Francisco, United StatesOverview: · 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 contribut ...
-
Pharmacometrician
1 day ago
Pfizer South San Francisco, United States Full timeJOB SUMMARY · With guidance, contribute to the development of the model informed drug development (MIDD) plans for an assigned project in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners. · Conduc ...
-
Amgen South San Francisco, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collabor ...
-
BioSpace South San Francisco, United StatesJob Details · HOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global col ...
-
Amgen Inc. South San Francisco, United StatesJOB ID: R LOCATION: US - California - South San Francisco WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Feb. 14, 2024 CATEGORY: Scientific SALARY RANGE: 142,936.00 USD - 171,592.00 USD · HOW MIGHT YOU DEFY IMAGINATION? · If you feel like you're part of something bigger, ...
-
Amgen South San Francisco, United States Full timeHOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who ...
-
Structure Therapeutics Inc South San Francisco, United StatesPOSITION 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 pipeline molecules. The position will contribut ...
-
Associate Director, Clinical Pharmacology and DMPK
17 hours ago
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 ...
-
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 ...
-
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 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 ...
-
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 ...
-
Associate Director, Clinical Pharmacology and DMPK
11 hours ago
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 ...
-
Scientist 3, Clinical Pharmacology
3 weeks ago
Genentech South San Francisco, United StatesThe Position · We advance science so that we all have more time with the people we love. · The Clinical Pharmacology (CP) Scientist 3 is responsible for the delivery of PK/PD analyses and reports for their assigned development project[s] in order to ensure that appropriate dose/r ...
Director, Quantitative Pharmacology - South San Francisco, United States - Denali Therapeutics
Description
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The Company is seeking to hire a Director, Quantitative Pharmacology within the Quantitative and Clinical Pharmacology sub-function in Development Sciences to develop and execute modeling and simulation (M&S) strategies supporting preclinical translational pharmacology efforts and all stages of clinical development.
The incumbent will play an important part in advancing Denali's portfolio of novel blood-brain-barrier penetrant transport vehicle (TV) biotherapeutics, including oligonucleotide transport vehicle (OTV) clinical candidates, and small molecule programs in clinical development.
ResponsibilitiesSalary Range:
$223, $253, Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Applicant Privacy Policy