Job Listing: Associate Medical Director

Aerotek Clinical Research is currently seeking an Associate Medical Director for one of our client sites in the Malvern, PA area for a temp to perm position.

DUTIES AND RESPONSIBILITIES

Responsible for successful implementation and operational aspects of Phase I to III clinical studies in the United States.
Direct/lead the Team to ensure successful completion of US Phase I, II and III clinical trials in a timely, ethical and a scientifically responsible fashion.
Evaluate feasibility of, and direct a program of Phase I, II and III clinical research involving products leading to the filing of an NDA.
Ensure training of the team regarding the product, the pathology, the regulatory environment, the protocol and the CRF. Maintain a network of experts and potential investigators within his/her therapeutic field. Identification and evaluation of investigators.

Medical representative responsibilities: SAE, narrative summaries; active collaboration with the corresponding clinical operations department; presentation of the trial, presentation of trial results, provide answers to questions of a medical nature; participation in important congresses or events concerning the therapeutic field.

Duties and Responsibilities
- Evaluation of the feasibility in his/her country of clinical trials proposed by the client. Evaluate the synopsis; collect information and documentation concerning the proposed study that will help determine its feasibility and provide support for the eventual go/no-go decision; formalization of a commitment to objectives set, in terms of number of patients and investigating centers and delays for study conduct.
- Maintaining a network of experts and potential investigators within his/her therapeutic field; identify potential investigator's site competence and their capacity to respect the trial commitments; approve site selection.
- Direct/lead the Team that is conducting US Phase I, II and III clinical trials in a timely, ethical, and a scientifically responsible fashion.
- Presentation of the trial, presentation of trial results, provide answers to questions of a medical nature. Participation in important congresses or events concerning the therapeutic field. Serve as a medical monitor for these trials and be responsible for the ongoing review of these trials and of the projects as regards US regulations in particular.
- Review SAE, narrative summaries, Interact with the pharmacovigilance department to ensure that serious adverse events, involving this US clinical development, are followed up, evaluated, reported to regulatory authorities (FDA) and notified to US Investigators promptly.
- Ensure that all activities under his/her direction comply with Clinical Development Standard Operating Procedures (SOP's), Good Clinical Practice and US Regulations.
- Provide appropriate mentoring on the drug development process, and provide assistance with the career development of team members and reportees.

Knowledge and Skills
- This position requires an individual with a strong understanding of medical practice as well as the scientific research process.
- Strong verbal and written skills are required.
- The ability to interpret clinical data accurately is essential.
- Eagerness to commit to the completion of tasks within an aggressive but realistic time frame is essential.
- Ability to function in a transatlantic pharmaceutical research environment is essential.

Formal Education/Experience
- Medical degree, US Board Certification or Board Eligibility, or relevant medical subspecialty with focus on cardiovascular diseases
- At least 1-3 years clinical research experience in pharmaceutical setting or equivalent; demonstrated in communication and personal interaction.

Knowledge and Skills Desirable but not Essential
- Ability to read and write French.

This is a temp to perm position with our client in Malvern, PA.

Required Skills for Associate Medical Director Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.