Jobs
>
Irvine

    Medical Director, Neuroscience Clinical Development - Irvine, United States - AbbVie

    Default job background
    Description


    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

    We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

    For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Job Description+ Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.

    Oversees project-related education of investigators, study site personnel, and AbbVie study staff.+ Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.

    Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.

    Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.+ Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.+ May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.+ Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.

    May participate in due diligence or other business development activity.

    As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.+ May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.

    In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB).+ Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.+ Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.+ Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.

    Serves as a clinical representative for key regulatory discussions.+ Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

    Qualifications+ Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non
    • US equivalent of M.
    D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred.

    Completion of a subspecialty fellowship is desirable.+ At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.+ Ability to run a clinical research program of moderate complexity with minimal supervision.+ Ability to perform and bring out the best in others on a cross-functional global team.+ Ability to interact externally and internally to support a global scientific and business strategy.+ Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.+ Must possess excellent oral and written English communication skills.


    • Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
    • + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.+ This job is eligible to participate in our short-term incentive programs. + This job is eligible to participate in our long-term incentive programs.
    • Note:

    No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

    The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

    AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

    It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.



  • Edwards Lifesciences Irvine, United States

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...


  • RegenIntel Bioscience Brea, United States

    **RegenIntel Bioscience, Inc - Job Location: Brea, CA** · RegenIntel Bioscience, Inc has an immediate need to hire a Director - Clinical Development. · **Desired Skills and Experience** · This key role will manage all aspects of clinical trials (Phase I-III), plan, and execute cl ...


  • Edwards Lifesciences Corp Irvine, United States

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...


  • Edwards Lifesciences Irvine, United States

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...


  • Edwards Lifesciences Corporation Irvine, United States

    Imagine how your ideas and expertise can change a patients life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients lives. As part of our Clinical Affairs t Clinical, Specialist, Developme ...


  • Allergan Aesthetics Irvine, United States

    Job Description · Job DescriptionCompany Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, ...


  • AbbVie, Inc Irvine, United States

    Company Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consist ...


  • BioSpace Irvine, United States

    Job Details · Company Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal ...


  • AbbVie Irvine, United States

    Company Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consist ...


  • Allergan Aesthetics Irvine, United States

    Job Description · Job DescriptionCompany Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, ...


  • Edwards Lifesciences Corporation Irvine, United States

    Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patie Clinical, Development, Special ...


  • Edwards Lifesciences Irvine, United States

    Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve re ...


  • Edwards Lifesciences Corp Irvine, United States

    Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve re ...


  • Edwards Lifesciences Gruppe Irvine, United States

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. · Engineer I, Clinical Development page is loaded · Engineer I, Clinical Development · Apply · locations · USA - Cal ...


  • Edwards Lifesciences Irvine, United States

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Medical Affairs team, you'll hone your scientifi ...


  • AbbVie, Inc Irvine, United States

    Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...


  • AbbVie Irvine, United States

    Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...


  • Concordia University - Irvine Ca Irvine, United States

    **Role**:The Coordinator of Field Experience in the Department of Nursing provides leadership in implementing and managing relationships with both current and future clinical partners for the MSN-FNP Program. The Coordinator is responsible for building clinical partnerships, iden ...


  • Edwards Lifesciences Irvine, United States

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...


  • Edwards Lifesciences Irvine, United States

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...