Scientific Director Oncology Clinical Development - North Chicago, United States - AbbVie
Description
Primary Function:
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 0-5 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 on-going 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 sub-teams responsible for defined sub-projects 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
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 a plus.
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 registration enabling clinical trials is vital.
Knowledge of regulatory requirements governing clinical trials and experience in the design and successful execution of registration-track 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 self-starter.
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.