- Ph.
- Extensive pharmacometrics analysis experiences with proven track record of independent hands-on experience in study design, data analysis, modeling-simulation. Proficiency in using modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, or other similar tools)
- Excellent interpersonal, organizational, and teamwork skills required to communicate effectively with external collaborators and internal project teams.
- Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements to support clinical development and regulatory submission.
- Experience with managing external resources including CROs and consultants
- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
-
Clinical Pharmacology, Director
1 week 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 ...
-
Clinical Pharmacology, Director
1 week 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
2 weeks 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 ...
-
Senior Director, Clinical Pharmacology
1 week ago
Third Rock Ventures San Francisco, United StatesAt 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 our Clinical Sci ...
-
Senior Director, Clinical Pharmacology
6 days ago
FibroGen San Francisco, United StatesAPPROVED FOR REMOTE WORK · Company Overview · FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for the ...
-
Associate Director Clinical Pharmacology
1 week ago
TANNER & ASSOC INC San Francisco, United StatesAssociate Director Clinical Pharmacology – San Francisco Biotech · New Position: Associate Director Clinical Pharmacology – San Francisco Biotech · Position Summary: · The Associate Director role will have a broad range of responsibilities and oversight of programs in oncology, ...
-
Senior Director, Clinical Pharmacology
2 weeks ago
FibroGen, Inc. San Francisco, CA, United StatesAPPROVED FOR REMOTE WORK Company Overview FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for the tr ...
-
Senior Director, Clinical Pharmacology
1 week ago
FibroGen San Francisco, United StatesAPPROVED FOR REMOTE WORK · Company Overview · FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for t ...
-
Director, Clinical Pharmacology
2 weeks ago
BeiGene Emeryville, 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 pharmacol ...
-
snaphire San Francisco, CA, United States89bio 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 engineered glyc ...
-
Senior Director, Clinical Pharmacology
1 week 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
2 weeks 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
1 week 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
2 weeks 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 ...
-
Director, Clinical Pharmacology
1 week 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 ...
-
Director, Clinical Pharmacology
1 week ago
BioSpace Foster City, United StatesJob Details · Director, Clinical Pharmacology - Virology · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each ne ...
-
Director, Clinical Pharmacology
1 week ago
Protagonist Therapeutics Newark, United StatesDIRECTOR CLINICAL, PHARMACOLOGY · The Director, Clinical Pharmacology, role is a critical function that will be responsible for leading the design, planning, and execution of clinical pharmacology programs. The candidate will work closely with colleagues in clinical development, ...
-
Director, Clinical Pharmacology
1 week ago
Protagonist Therapeutics Newark, United StatesDIRECTOR CLINICAL, PHARMACOLOGY · The Director, Clinical Pharmacology, role is a critical function that will be responsible for leading the design, planning, and execution of clinical pharmacology programs. The candidate will work closely with colleagues in clinical development, ...
-
Senior Director, Clinical Pharmacology
1 week 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
1 week 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 ...
Director/Senior Director, DMPK and Clinical Pharmacology - San Francisco, United States - IDEAYA Biosciences, Inc.
Description
IDEAYA 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 extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing.
We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality - which represents an emerging class of precision medicine targets.
We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response.
IDEAYA has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.
When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients.
We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA.
We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.
For more information, please seeWhat you'll do:
Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development, including authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products.
One of the key roles of this position is to apply state-of-art pharmacometrics methodologies that encompass disease, drug exposures, and modelling to support drug discovery, development and regulatory decisions.
Expertise in model-based analyses such as population pharmacokinetic and pharmacokinetic-pharmacodynamic modelling, exposure-response (ER) analyses, quantitative systems pharmacology modelling (QSP), physiological-based pharmacokinetic (PBPK) modelling, optimal study design, are highly desired.
Provide high-quality scientific knowledge/insight and drive the customized clinical pharmacology and DMPK plansWrite, review and edit relevant sections of regulatory documents ((IND's, NDA's, IB's, etc.) and respond to regulatory inquires related to line function
Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
Lead writing of scientific publications on relevant topics - abstracts, posters, oral presentations and manuscripts
Engage and manage CRO's to support appropriate pharmacometrics analyses and ensure compliance with agreed protocols, quality standards and timelines
Requirements:
The salary range for this position at the Director level is between $223,449 and $272,495. The salary range is an estimate and may vary based on the Company's compensation practices.
The salary range for this position at the Senior Director level is between $273,771 and $337,470. The salary range is an estimate and may vary based on the Company's compensation practices.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.
This position requires you to work onsite at the Company's facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).
Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.
The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.
The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Benefits
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs.
IDEAYA is an equal opportunity employer.
In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status.
EOE/AA/Vets.California Job Applicant Privacy Notice
