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Senior Manager - Clinical Development

Employer
AbbVie
Location
Irvine, CA
Salary
$117,500 - $223,500
Start date
Nov 8, 2024
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Job Details


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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.


Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. The Senior Manager, ClinicalDevelopment (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.

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 preclinical 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

Minimum Qualifications:

Relevant science degree (Masters, MD, PharmD, PhD)
Minimum 5 years of overall work experience
Minimum 4 years of clinical/research experience (clinical operations, clinical research, clinical study review etc.)

Preferred Qualifications:

Pharmaceutical/Device industry experience
Experience in an Aesthetics Therapeutic Area


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

  • The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

  • This job is eligible to participate in our short-term incentiveprograms.

  • This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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
United States

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