Scientific Director Immunology Clinical Development
Scientific Director Immunology Clinical Development
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Salary Not Disclosed
1 Vacancy
Job Description
In conjunction with Clinical Leader designs directs plans executes and interprets clinical trials/research and data collection activities. The successful candidate will utilize scientific methods for design and implementation of clinical protocols and data collection systems to enable final reports. Coordinates clinical team activities needed to produce clinical study reports.
A successful applicant may recruit clinical investigators and negotiate study design. Responsibilities also may include directing the execution of human clinical trials phase I IV for company products under development Coordination and development of information for reports submitted to the FDA and Global Regulatory Authorities. The successful applicant will monitor adherence to protocols and determine study completion. Also this individual will act as a consultant/liaison/resource with other corporations when working under licensing agreements.
Responsibilities:
Assists in the design of clinical studies and clinical development plans. Responsibilities may extend from early translational development activities to mature product life cycle strategies.
In conjunction with Clinical Leader designs conducts and reports clinical trials in line with the development regulatory and commercial strategy.
May lead 05 employees in a matrixed environment. May be responsible for opinion leader development within the therapeutic area Interacts with and coordinates appropriate scientific activities with internal stakeholders (i.e. commercial clinical operations discovery statistics regulatory etc) as they relate to ongoing clinical studies or projects.
Assists as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
Assists in scientific education of investigators clinical monitors and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences or medical literature and acts as a therapeutic area resource.
Represents AbbVie at external meetings including investigator meetings scientific association meetings partner discussions etc.
Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements
May lead cross functional subteams responsible for defined subprojects within the therapeutic area (individual publications or study collaborations).
May initiate research projects compatible with project plan goals and drive them to completion resulting in high quality publications
Qualifications :
Advanced education (e.g. PhD PharmD PA NP or MBA with significant germane experiences) preferred. Residency post doc or/ post graduate degree and/or significant leadership responsibilities and practical experience in successful oncology registration trial programs is especially important.
Consequential experience with successful development of novel compounds or delivery systems in oncology indications is vital. Involvement in programs with similar product profiles as those in development by AbbVie or with AbbVie oncology clinical partners is very desirable.
Typically 8 years experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area is required. Knowledge of clinical trial methodology coupled with performance in oncology registration enabling clinical trials is vital.
Knowledge of regulatory requirements governing clinical trials and experience in the design and successful execution of registrationtrack protocols leading to NDA submission highly favored. May have performed protocol design in the academic environment and/or acted as an assistant Principal Investigator or Principal Investigator.
Internal and external interactions normally require the ability to gain cooperation of others conduct presentations of technical information concerning specific projects/schedules etc. Ability to interact externally and internally to support global business strategy is vital. Direct experience with external interactions with regulatory bodies (FDA and/or EMEA personnel) is highly advantageous.
Successful candidate must possess excellent oral and written communication skills and demonstrable evidence of being a motivated and successful selfstarter.
Additional Information :
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
