The Company seeks an outstanding Clinical Affairs Professional who will be responsible for Clinical Affairs functions, including clinical trials. This individual will be responsible for working closely with our development team to ensure effective Phase I, II and III clinical trial design and execution.
The Clinical Affairs Professional is responsible for ensuring effective design of experimental protocols, developing/maintaining relationships with key thought leaders and reviewing promotional materials for scientific accuracy.
The Clinical Affairs Professional will help establish the studies essential for determining the safety, efficacy and marketability of drug candidates. He/she will also serve as a monitor responsible for overseeing contract research organization (CRO) activities, the implementation of clinical trials and the interpretation of clinical results. The Clinical Affairs Professional will work closely with our R&D, Product Development and Regulatory groups.
Designs clinical trial protocols and selects Clinical Investigators and Clinical Research Organizations
Writes clinical sections of regulatory documents, including the Investigational New Drug Application and applications for marketing approval
Evaluates safety data from clinical trials and assists in reporting safety findings to regulatory authorities and licensing partners
Writes clinical study reports according to regulatory (FDA/ICH) guidelines
Reports status of clinical programs to Project Teams and Management
Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
Manages clinical trial budget for both CROs and study sites
Assists project teams to identify clinical indications appropriate for the investigational drugs
IN ADDITION THE CANDIDATE WILL HAVE:
BS/MS degree in biomedical science and experience preferably in infectious disease.
Minimum 3-5 years experience in a pharmaceutical or biopharmaceutical company, preferably in a fast-paced, dynamic environment. Demonstrated experience in successful clinical development of drug candidates from pre-clinical activities through clinical trials and successful product approval(s) is important.
Demonstrated expertise in managing complex collaborations and teams in support of executing clinical trials effectively, including effective management of projects and timelines, is desirable.
Must be knowledgeable with FDA requirements, good clinical practices and pharmaceutical clinical development.
Excellent oral, written and interpersonal communication skills required.
Must be open to some travel.
Compensation is commensurate with experience.
Advanced Life Sciences offers a competitive benefits package that includes medical, dental, life and disability insurance, 401k plan and more.
For further details, please visit our web site at www.advancedlifesciences.com .
For consideration, please send your Curriculum Vitae to:
1440 Davey Road
Woodridge, IL 60517
Please attach your resume in Word or PDF format.
Please, no telephone requests.
At Advanced Life Sciences we value our employees and offer a competitive benefits package that includes medical, dental, life and disability insurance, 401k plan and more.
Advanced Life Sciences is an equal opportunity employer and openly complies with all federal, state and municipal laws which prohibit discrimination because of age, race, color, religion, sex, nationality or disability.