Job Title: Medical Director – Translational Medicine
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Vacancy details
Vacancy description:
Job Code:
JD 00269
Job Title:
Medical Director – Translational Medicine
Job Category:
Physicians
Contract:
Locum/Temporary
Discipline:
Medical Director
Country:
United States Of America
Location:
New Jersey
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
02 Jun 2008
This highly prestigious, key role is with a Japanese based global pharmaceutical company that conducts clinical studies and expedites product registrations in the USA and Europe. They develop and deliver new therapies in a variety of therapeutic areas for patients around the world and are seeking an exceptional candidate as Medical Director of Experimental Medicine who will work under the direction of the Executive Director, Translational Medicine at the company’s office in Edison, NJ
JOB ROLE – Principal Responsibilities include:
• Ensuring effective, scientifically sound, medically appropriate and consistent design and conduct of Phase 1 studies especially for compounds with novel or unknown mechanism of action. These studies include:
• First-in-human single-dose ascending and repeat-dose ascending.
• No-product enabling/methodology and ‘Phase 0’ studies such as microdosing and Exploratory IND (referred to as “Translational Medicine Phase 1 studies”),
• Other pharmacodynamic studies in healthy volunteers and patients.
• Overseeing study protocol writing, clinical conduct and medical monitoring of studies.
• Collaborating with pre-clinical research during IND-enabling phase of drug development to facilitate effective translation of compounds into the clinic and timely filing of high quality IND/CTA dossiers.
• Overseeing the collaboration of Experimental Medicine with supporting functions within the project timelines
• Periodically providing feedback to pre-clinical research on the clinical outcomes of Translational Medicine Phase 1 studies.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
• MD (preferred) or PhD
• At least 5 years of academic or pharmaceutical industry experience (preferably in clinical pharmacology), with at least 3 years having responsibility for design and conduct of Phase 1 study protocols.
• Experience across multiple therapeutic areas is very desirable.
• Evidence of implementation and oversight of novel methodological approaches coupled with a strong focus on set up and conduct of exploratory clinical studies.
• Experience in issues around design and conduct of Phase 1 studies, and in regulatory and pre-clinical issues.
• Familiarity with ICH, FDA and GCP guidelines governing clinical trial design and conduct, biomarkers, pharmacogenomics and clinical technologies.
PERSONAL SKILLS & ATTRIBUTES:
• The ability to work with minimal supervision to identify, prioritize and resolve problems.
• The ability to manage individuals and lead multi-disciplinary teams.
BENEFITS OF THE ROLE: This Company is acutely aware that their employees form an integral part in shaping their overall success. They are offering an excellent executive salary commensurate with the role together with benefits that are truly competitive and tailored to the individual’s personal needs and lifestyle. These include: Comprehensive Healthcare, Life & Accident Insurances, Short & Long Term Disability Benefits, 401(k) Savings Plan, Employee Assistance, Tuition and more.
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors with a glowing reputation in the industry. For applications please email your CV to: damon@fforde-management.com or speak to our specialist consultant, Damon Bacote who will be pleased to give you further information and advise on your personal career needs. Tel: +1 212 520 8304
Visit our website at www.fforde-management.com
KEY WORDS: Medical Director, Translational Medicine, Experimental Medicine, Clinical Studies, Phase I, First in Human, Microdosing, Exploratory IND, Pharmacodynamic Studies, Protocol Writing, Drug Development, Pre-Clinical Research, MD, PhD, Clinical Pharmacology, ICH, FDA, GCP, Clinical Trial Design, Biomarkers, Pharmacogenomics, Clinical Technologies, Pharmaceutical
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