Jobs
>
Emeryville

    Director, Clinical Pharmacology - Emeryville, United States - BeiGene

    BeiGene
    BeiGene Emeryville, United States

    3 weeks 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.

    #J-18808-Ljbffr
  • AbbVie

    Director, Clinical Pharmacology

    1 week ago

    AbbVie South San Francisco, United States

    **Company Description** · Purpose · Describe the primary goals, objectives or functions or outputs of this position. · Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strate ...

  • Exelixis

    Vice President, Clinical Pharmacology

    2 weeks ago

    Exelixis Alameda, United States

    SUMMARY/JOB PURPOSE: · The VP, Clinical Pharmacology builds and leads an experienced team of clinical pharmacologists with responsibilities to integrate clinical pharmacology strategies across pre-clinical and clinical development, including drug approval and post-approval activi ...

  • Exelixis Inc.

    Vice President, Clinical Pharmacology

    1 week ago

    Exelixis Inc. Alameda, United States

    SUMMARY/JOB PURPOSE: · The VP, Clinical Pharmacology builds and leads an experienced team of clinical pharmacologists with responsibilities to integrate clinical pharmacology strategies across pre-clinical and clinical development, including drug approval and post-approval activi ...

  • 89bio

    Clinical Pharmacology, Director

    2 weeks 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 ...

  • Exelixis

    Vice President, Clinical Pharmacology

    1 week ago

    Exelixis Alameda, United States

    SUMMARY/JOB PURPOSE: · The VP, Clinical Pharmacology builds and leads an experienced team of clinical pharmacologists with responsibilities to integrate clinical pharmacology strategies across pre-clinical and clinical development, including drug approval and post-approval acti ...

  • Exelixis

    Vice President, Clinical Pharmacology

    1 week ago

    Exelixis Alameda, United States

    SUMMARY/JOB PURPOSE: · The VP, Clinical Pharmacology builds and leads an experienced team of clinical pharmacologists with responsibilities to integrate clinical pharmacology strategies across pre-clinical and clinical development, including drug approval and post-approval activi ...

  • 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 ...

  • 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 ...

  • 89bio

    Clinical Pharmacology, Director

    5 days 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 e ...

  • 89bio

    Clinical Pharmacology, Director

    4 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 ...

  • BeiGene

    Director, Clinical Pharmacology

    3 weeks 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 ...

  • BioSpace

    Director, Clinical Pharmacology

    3 weeks 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 ...

  • Third Rock Ventures

    Senior Director, Clinical Pharmacology

    3 weeks ago

    Third Rock Ventures San Francisco, United States

    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 our Clinical Sci ...

  • Protagonist Therapeutics

    Director, Clinical Pharmacology

    4 days ago

    Protagonist Therapeutics Newark, United States

    DIRECTOR CLINICAL, PHARMACOLOGYThe 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, cli ...

  • 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, ...

  • Protagonist Therapeutics

    Director, Clinical Pharmacology

    3 weeks 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, ...

  • FibroGen

    Senior Director, Clinical Pharmacology

    2 weeks ago

    FibroGen San Francisco, United States

    APPROVED 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 ...

  • TANNER & ASSOC INC

    Associate Director Clinical Pharmacology

    3 weeks ago

    TANNER & ASSOC INC San Francisco, United States

    Associate 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, ...

  • FibroGen

    Senior Director, Clinical Pharmacology

    3 weeks ago

    FibroGen San Francisco, United States

    APPROVED 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 ...

  • FibroGen, Inc.

    Senior Director, Clinical Pharmacology

    4 weeks ago

    FibroGen, Inc. San Francisco, CA, United States

    APPROVED 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 ...