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WHAT
IN
Director Clinical Development
Job
Allergan
US
-
Irvine,
California
Job Code - 090712
Position - See job description
Job First Active on: Thursday, November 05, 2009
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JOB DESCRIPTION: Director, Clinical Development
Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs - and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.
The Medical/Clinical Director is responsible for providing scientific, medical and clinical development direction and guidance at the product, project and study level. There are several roles that can be fulfilled by the Medical/Clinical Director. As the Clinical Lead of the Clinical Team, s/he is accountable for the leadership of the clinical development activities with the members of the Clinical Team. In collaboration with Global Development Operations functions, s/he defines, prepares and monitors clinical study activities, progress, execution, and budgets and ensures expenses are managed to meet forecasts. The Clinical Scientist role has responsibility for the content, creation, development, and updates of several key Development documents including: Clinical Development Plan, Investigator Brochures, the Study Protocol Synopsis, Study Protocols, Clinical Study Reports, and other documents included in regulatory submissions. The role of a Medical Monitor is to ensure the safety of study subjects through ongoing review of all relevant safety data and oversight of the safety aspects for the clinical study. In addition, the Medical Monitor works in close collaboration with the regulatory reporting group to be in compliance with relevant regulatory reporting requirements related to patient safety.
The Medical/Clinical Director represents R&D at regulatory agency meetings, symposia and trade associations and aims to establish and maintain a strong network within the Pharmaceutical industry.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives
REQUIREMENTS - QUALIFICATIONS: Director, Clinical Development
Advanced degree with extensive subspecialty training in therapeutic area or significant experience working in clinical research with an understanding of the clinical and drug development process in a global pharmaceutical/biotechnology company
MD, PhD, or PharmD strongly preferred
Knowledge:
Incumbent must have a good understanding of the following:
Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
Knowledge of concepts of clinical research and drug development, and
General therapeutic area education and training
In addition to the competencies and essential skills, the incumbent must have the following:
Excellent communication skills, across departments and globally
Ability to multi-task, prioritize, and work independently with minimal supervision and guidance
Excellent planning, organizational, project management and presentation skills
Experience working with functions in a development organization that is global
Flexibility in approaching tasks and overcoming challenges
Ability to problem solve independently and with others
Ability to influence others without direct reporting relationships
Ability to make good business decisions that may be unpopular
Strong networking and interpersonal skills in order to succeed in a matrix organization
A self starter
Strong analytical skills
Strong conflict management skills
Cross-cultural sensitivity
Proactive and critical evaluation of the multiple aspects of trial design to ensure timely delivery of results with excellent quality
Strong team leadership skills
Ability to meet challenging milestones
Ability to problem solve independently and with others
Advanced computer skills (word processing, spreadsheets, graphics, Power point)
Allergan
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