Jobs
>
South San Francisco

    Director, Clinical Science - South San Francisco, United States - Hibio

    Hibio
    Hibio South San Francisco, United States

    2 weeks ago

    Default job background
    Description

    TYPE:
    Full-Time (Onsite / Hybrid)
    Are you an experienced scientist with clinical research experience in kidney and/or immune-mediated diseases? Join HI-Bio, Inc.

    a clinical-stage biotechnology company based in South San Francisco, California, and be part of a fast-paced organization on an outstanding team of cross functional clinical research professionals translating scientific insights into our clinical development programs across a wide range of unmet needs.

    Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact.

    We have a precision medicine approach akin to oncology and grounded in human genetics. Our pipeline is strong and built through in-licensing and discovery. HI-Bio's team is made up of industry experts from science and clinical development. We are on a path to building the leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.

    We are seeking a senior Clinical Scientist to support clinical research activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases.

    This position provides leadership in program development, execution, innovation, and optimization of clinical trials by including the latest insights on disease mechanisms, diagnostic approaches, and alternative therapies.

    The Director will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications.

    Additional responsibilities involve assisting with regulatory documentation by collaborating with discovery, development, and commercial colleagues, as well as managing external collaborations and gaining comprehensive knowledge of the literature related to the product(s) in development.

    The responsibilities of this role may vary depending on the specific indication and trial requirements.
    The Clinical Scientist collaborates closely with Study Physicians/Scientists as a key member of development and core team. The role actively contributes scientific expertise to cross-functional clinical teams involved in the development of novel therapies.

    As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.

    Our ideal candidate will have significant experience in clinical trials for antibodies and can strongly communicate and present relevant clinical data to leadership and core teams.


    KEY RESPONSIBILITIES:
    Support the preparation of clinical development plans, trial protocols, case report forms, and study operational plans that are scientifically rigorous, clinically relevant, operationally feasible, while adhering to GCP and regulatory requirements
    Establish and maintain credible relationships with clinical investigators and medical/scientific experts
    Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
    Assist Data Management with the review of clinical data and resolution of queries
    Perform medical monitoring activities and reporting in partnership with Study Responsible Physicians/Scientists, including evaluating clinical trial adverse events and reviewing clinical laboratory results
    Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials
    Draft and coordinate completion of clinical study reports
    Prepare responses to questions from Ethics Committees and Health Authorities
    Support integrated document development for marketing authorization filing
    Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
    Support preparation for FDA Advisory Committee and EU Oral Explanation
    Present relevant clinical data to internal and external stakeholders
    Review medical literature and related new technologies relevant to the assigned projects.
    Other responsibilities may include utilizing nonclinical PK and PK/PD data (including use of modeling and simulation techniques) to project optimal clinical dosing regimens, doses based on pharmacological/clinical targets, human starting doses, and biomarker exploratory data (including biochemical and molecular data from quantification of mRNA, multi-panel flow cytometry, and protein expression)
    Collaborate with early research teams in assessing PK and other data for use in future programs and to optimize experimental design
    Author regulatory documents as it relates to clinical pharmacology data and design
    Evaluate and implement necessary tools and systems to organize and analyze data
    Conduct clinical studies with utmost integrity, professionalism, and organization

    QUALIFICATIONS:
    PhD/PharmD with 5+ years of industry clinical research experience, preferably in immunology or a related therapeutic area. BS/MS/RN will be considered with additional industry and drug development experience
    Experience in late-stage drug development, with a preference for experience in immuno-inflammatory indications
    Strong analytical skills coupled with communication skills to present findings and relevant data
    Ability to survey and interpret scientific literature related to assigned projects
    Strong organizational skills and ability to thrive in a fast-paced startup environment while prioritizing and responding to changing business needs
    Demonstrated ability to collaborate effectively with cross functional teams and champion and drive solutions for clinical challenges
    Excellent written and verbal English communication skills
    Ability to interface with health authorities and represent clinical programs with integrity, polish, and professionalism
    Ability to travel domestically and internationally, approximately 10-20% of the time.

    HIBIO RECRUITING:
    HI-Bio, Inc. is an equal opportunity employer.

    We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

    We are committed to creating an inclusive environment for all employees. HI-Bio Inc. does not accept unsolicited resumes from any agency that we have not directly engaged on a specific role. Our managers and employees will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to HI-Bio, Inc. from recruiters do not constitute any type of relationship between the recruiter and/or recruiting agency and HI-Bio, Inc. and do not obligate HI-Bio, Inc. to pay fees should we hire from those resumes.

    #J-18808-Ljbffr
  • Bristol-Myers Squibb

    Clinical Science Lead

    1 week ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol Myers Squibb

    Clinical Science Lead

    1 week ago

    Bristol Myers Squibb Brisbane, United States

    Working with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    1 week ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    2 weeks ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    3 weeks ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    2 weeks ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    3 days ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    2 weeks ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    3 weeks ago

    Bristol-Myers Squibb Brisbane, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol Myers Squibb

    Clinical Science Lead

    1 day ago

    Bristol Myers Squibb Brisbane, United States Full time

    Working with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...

  • BioSpace

    Associate Director, Clinical Science

    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 an Associate Director, Clinical Sci ...

  • CytomX Therapeutics

    Senior Director, Clinical Sciences

    1 week ago

    CytomX Therapeutics South San Francisco, United States

    Headquarters Location: South San Francisco, CA · Candidate Location: Hybrid · Travel Required: 5% · Reports To: Vice President, Clinical Development · Department: Clinical Development · Position Type: Full-time, Exempt · About CytomX Therapeutics: · CytomX Therapeutics, Inc. is c ...

  • Maze Therapeutics

    Associate Director, Clinical Science

    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 an Associate Director, Clinical Science to join o ...

  • Maze Therapeutics

    Associate Director, Clinical Science

    3 weeks 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 an Associate Director, Clinical Science to join o ...

  • Maze Therapeutics

    Associate Director, Clinical Science

    2 weeks 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 an Associate Director, Clinical Science to join ...

  • Maze Therapeutics

    Associate Director, Clinical Science

    1 week 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 an Associate Director, Clinical Science to join o ...

  • Nkarta Inc

    Associate Director/Director, Clinical Science

    3 weeks ago

    Nkarta Inc South San Francisco, United States

    About Us · Nkarta Therapeutics is a publicly traded (Nkarta NKTX symbol), South San Francisco headquartered, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell t ...

  • Nkarta, Inc.

    Associate Director/Director, Clinical Science

    2 weeks ago

    Nkarta, Inc. South San Francisco, United States

    About Us · Nkarta is a publicly traded (Nasdaq symbol NKTX), biotechnology company headquartered in South San Francisco focused on the discovery, development and manufacturing of off-the-shelf, natural killer (NK) cell therapies. Our near-term goal is to bring cell therapy out in ...

  • Nkarta Inc

    Associate Director/Director, Clinical Science

    2 days ago

    Nkarta Inc South San Francisco, United States

    About Us: · Nkarta Therapeutics is a publicly traded (Nkarta NKTX symbol), South San Francisco headquartered, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell t ...

  • Nkarta Inc

    Associate Director/Director, Clinical Science

    3 weeks ago

    Nkarta Inc South San Francisco, United States

    About Us: · Nkarta?is a publicly traded (Nasdaq?symbol?NKTX), biotechnology company headquartered in South San Francisco focused on the discovery, development and manufacturing of off-the-shelf, natural killer (NK) cell therapies. Our near-term goal is to bring cell therapy out ...