MD, VP Clinical Development/Sr Medical Dir, must have interactions of antibacterials @ FDA level

Dear Fellow Professionals,

The following position needs to be filled soon, and we are willing to pay a $1000.00 finder's fee.

Warm Regards, ciao, Namaste
Joe
Joseph Anthony Vaccariello
860 889 4141, until 9 PM EST, 7 days a week
joseph8601@sbcglobal.net
A New Beginning-Genesis 2
"http://www.linkedin.com/pub/3/945/77" target="_blank">http://www.linkedin.com/pub/3/945/77

Salary target 225 maybe up to 250k. bonus target 20%, stock options. Need to be on site for a few days each week or on road visiting key investigators for their trials. VP Clinical Development / Senior Medical Director, depending on experience level. MUST BE AN M.D., must have regulatory experience, infectious disease experience WILL only interview MDs who have recent (within the last 3 years) interactions of antibacterials at the FDA. Must know and have had had discussions with FDA on clinical programs in antibacterials. Must know current Cap and SSSI guidance documents for clinical trials. Must have run and managed clinical trials for antibacterials in the US and broad. Ability to present and defend clinical programs well.Good understanding of the microbiology and toxicology programs. Must not require a large infrastructure to work. Perform with CRO and consultants. Responsibilities: • Assist in clinical protocol design and the execution of clinical studies • Periodically travel to clinical sites to support principal investigator’s in the execution of clinical trials • Support regulatory affairs in the identification of relevant regulatory precedents and advise as to the most appropriate regulatory path to market. • Attend meetings with the FDA and serve as an advocate for trial / protocol design • Assure adherence to and compliance with all applicable FDA/ICH guidelines • Cultivate and maintain excellent working relationships with domestic and global health authorities, KOL’s, Principal Investigators and Investors Qualifications: Education/Certifications - • MD Professional Qualifications - The successful candidate will have prior experience and a demonstrated track record in a senior level clinical development or regulatory affairs function, such as a Director or Vice President. The candidate’s background will evidence increasing levels of responsibility within the Pharmaceutical, Biotechnology or CRO industry. Moreover, requirements include a demonstrated understanding of, and the ability to interpret, GCP/ICH/FDA standards and guidelines, as well as a clear understanding of internal and external resource management. The selected candidate should possess a strong desire to work in an innovative, emerging company and the accelerated growth environment that it entails. • Experience within the last three years in anti-bacterial drug development • A background evidencing support of regulatory filings • Recent and strategic interactions with the FDA (CDER) for IND and/or NDA filings regarding anti-bacterial drugs • The ability to be comfortable with current Cap and SSSI guidance documents for clinical trials • Must have run and managed clinical trials for anti-bacterials in the US and abroad • Willingness to travel (*estimated 35% average but could have higher peaks, at times) • Ability to communicate effectively, both internally and externally, to scientific audiences • Strong understanding of the microbiology and toxicology programs Characteristics: • Demonstrated influencing and negotiating ability • Self-starter • Excellent attention to detail • Passion, energy, personal drive and motivation • Outstanding written, oral, organizational, and interpersonal skills are required
Warm Regards, ciao, Namaste
Joe
Joseph Anthony Vaccariello
860 889 4141, until 9 PM EST, 7 days a week
joseph8601@sbcglobal.net
A New Beginning-Genesis 2
http://www.linkedin.com/pub/3/945/77