Jobs
>
San Mateo

    Director, Clinical Pharmacology - San Mateo, United States - BeiGene

    BeiGene
    BeiGene San Mateo, United States

    1 week ago

    Default job background
    Description

    _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 and pharmacometric expertise for:
    characterizing pharmacokinetic profiles; dose selection justification; assessing drug/food interaction potential; characterizing QT prolongation potential, etc.

    This will be accomplished by implementing novel quantitative techniques and working in close partnership with other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc.

    Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of pharmacokinetic and pharmacodynamic data; and authoring and defending the clinical pharmacology sections of regulatory filings.

    A working knowledge of global regulatory practices as they relate to clinical pharmacology-related areas of subject matter expertise is essential.

    Communication skills at all levels of interaction must be excellent.


    Essential Functions of the job:

    + Actively participate as the functional clinical pharmacology representative on project teams.+ Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre
    • IND and first in human testing through all phases of clinical development.
    + Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.+ Contribute to the design and analysis of PK data from patient clinical studies.+ Conduct hands-on clinical PK and pharmacometric data analysis.+ Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities.+ Present data and interpretations to health authorities to enable optimal clinical development and registration of novel drugs.+ Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.+ Represent Beigene in the external scientific environment – influencing partners and regulators in a positive way.+ Provide clinical pharmacology reviews on business diligence activities.


    Qualifications:

    A Ph.
    D.

    or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least eight years of industry and/or related post- doctoral experience is preferred.

    Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings and/or publications is essential. Familiarity with DMPK studies, bioanalytical methods is preferred. Prior experience in oncology drug development is preferred.


    Supervisory Responsibilities:

    + Direct management and mentoring junior members of the group as needed+ Manage clinical pharmacology vendors, and consultants for specific project needs
    Computer Skills
    :Hands-on experience in performing NCA using Phoenix WinNonlin is essential.

    Experience with one or more of the following is preferred:
    NONMEM, R, S-Plus, Berkeley Madonna, Simcyp, Gastroplus


    Education Required:

     Bachelors with 10+ years of experience or Masters with 7+ years of experience


    Travel:

    Ability to travel to manage clinical pharmacology collaborations and to global health authority interactions.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  • BioSpace

    Director, Clinical Pharmacology

    1 week ago

    BioSpace Foster City, United States

    Job 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 ...

  • Workday

    Senior Director, Clinical Pharmacology

    1 week ago

    Workday Foster City, United States

    For Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · to apply for this job. · At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment ...

  • 89bio, Inc.

    Clinical Pharmacology, Director

    1 week ago

    89bio, Inc. San Francisco, United States

    THE 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 ...

  • Revolution Medicines, Inc.

    Senior Director, Clinical Pharmacology

    1 week ago

    Revolution Medicines, Inc. Redwood City, United States

    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS p ...

  • Revolution Medicines, Inc.

    Senior Director, Clinical Pharmacology

    2 weeks ago

    Revolution Medicines, Inc. Redwood City, CA, United States

    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS p ...

  • 89bio

    Clinical Pharmacology, Director

    1 week ago

    89bio San Francisco, United States

    THE 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 ...

  • Maze Therapeutics

    Senior Director, Clinical Pharmacology

    6 days ago

    Maze Therapeutics South San Francisco, United States

    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 Pharmacology to join ...

  • BeiGene

    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 ...

  • Protagonist Therapeutics

    Director, Clinical Pharmacology

    1 week ago

    Protagonist Therapeutics Newark, United States

    DIRECTOR 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, ...

  • BioSpace

    Senior Director, Clinical Pharmacology

    1 week ago

    BioSpace South San Francisco, United States

    Job 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 ...

  • 89bio

    Clinical Pharmacology, Director

    2 weeks ago

    89bio San Francisco, CA, United States

    THE 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 ...

  • Protagonist Therapeutics

    Director, Clinical Pharmacology

    1 week ago

    Protagonist Therapeutics Newark, United States

    DIRECTOR 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, ...

  • Maze Therapeutics

    Senior Director, Clinical Pharmacology

    3 days ago

    Maze Therapeutics South San Francisco, United States

    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 Pharmacology to join ...

  • BioSpace, Inc.

    Senior Director, Clinical Pharmacology

    1 week ago

    BioSpace, Inc. South San Francisco, United States

    Job 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 ...

  • Maze Therapeutics

    Senior Director, Clinical Pharmacology

    2 weeks ago

    Maze Therapeutics South San Francisco, United States Full time

    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 Pharmacology to join ...

  • Maze Therapeutics

    Senior Director, Clinical Pharmacology

    2 days ago

    Maze Therapeutics South San Francisco, United States

    Job 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 ...

  • Maze Therapeutics

    Senior Director, Clinical Pharmacology

    1 week ago

    Maze Therapeutics South San Francisco, United States

    Job 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 ...

  • Ultragenyx Pharmaceuticals Inc.

    Senior Director, Clinical Pharmacology

    1 week ago

    Ultragenyx Pharmaceuticals Inc. Brisbane, United States

    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 modalitie ...

  • Maze Therapeutics

    Senior Director, Clinical Pharmacology

    2 days ago

    Maze Therapeutics South San Francisco, United States Full time

    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 Pharmacology to join ...

  • Maze Therapeutics

    Senior Director, Clinical Pharmacology

    3 weeks ago

    Maze Therapeutics South San Francisco, United States Full time

    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 Pharmacology to join ...