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Sr Manager, Clinical Development/Clinical Scientist II

Employer
AbbVie
Location
Irvine, California
Start date
Feb 8, 2024

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Job Details

Description - External

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. The Sr. Manager, Clinical Development (Devices) will have global or regional responsibilities and fulfill the role of Clinical Scientist and/or Clinical Science Lead within the Integrated Evidence Strategy Team (IEST). The Sr. Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.

YOU ARE more than just a title, YOU ARE…

First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

 

You Will:

In collaboration with a Therapeutic Area Scientific Director (TA-SD), the Clinical Scientist and/or Clinical Science Lead will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist and/or Clinical Science Lead will apply scientific training and clinical research experience to support all aspects of device and product development, from facilitating the transition from pre-clinical discovery to supporting the registration and commercialization of a product.

 

The position supports the Global Development Lead and TA-SD through the following responsibilities:

•Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of products in development. Attends congress and reviews literature to develop and augment expertise in therapeutic area

•Help develop program strategy including the clinical development plan, Integrated evidence plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities.

•Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).

•Participate in scientific education of internal and external stakeholders on the pre-clinical and clinical data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations.

•Contribute to the scientific content of Study Protocols, Investigator Brochures, IDFUs, Clinical Study Reports, Informed Consent Forms, and regulatory documents.

•Contribute to creation of electronic database, investigator meetings, and associated training documents and review data completeness and fidelity throughout study conduct.

•Collaborate cross-functionally to help create a scientific platform in support of the regulatory,

commercial and medical education strategy for late-stage assets.

 


    Qualifications:

    •Relevant science degree (e.g., Masters, MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Devices) preferred.

    •Minimum 5 years of overall work experience or equivalent combination of experience and

    education.

    •Minimum 4 years of clinical/research experience in the pharmaceutical/device industry

    preferred.

    •Ability to travel up to 15% of time, including international travel

    Applicable 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.


    Company

    AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

    Stock Symbol: ABBV

    Stock Exchange: NYSE

    Company info
    Website
    Phone
    1-800-255-5162
    Location
    1 North Waukegan Road
    North Chicago
    Illinois
    60064
    US

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