Full-Time ASSOCIATE DIRECTOR, CLINICAL SCIENCES
Cerexa, Inc., a subsidiary of Forest Laboratories, is a pharmaceutical development company that is focused on a growing portfolio of novel anti-infective therapies for the treatment of serious and life-threatening infections.
At Cerexa, Inc., we conduct our business with the highest ethical standards. We believe that our ability to positively impact health and save lives is directly linked with the experience and insight that our employees possess and our style of working in collaborative teams. We maintain an environment that recognizes and rewards achievement. We believe in focused goals, and individual and team accomplishments. Because of the collective experience of the development and management teams, we are able to execute aggressive timelines to achieve realistic outcomes.
For more information about Cerexa, Inc.: http://cerexa.com
Reporting to the Director of Clinical Development, the Associate Director will be a member of the clinical development team. This is an exempt level, full-time position.
- Design, develop, prepare, and initiate clinical study protocols and required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- Participate in the training of project teams, contract research organizations, and investigational sites/clinical investigators; including trouble-shooting and retraining staff regarding understanding and delivery of study protocol elements.
- Provide medical and scientific input to review of clinical data, patient medical safety data, and laboratory values; maintain an ongoing assessment of the safety profile and efficacy data.
- Provide medical surveillance on Serious Adverse Event (SAE) reporting and follow-ups, including after hours coverage of medical emergencies.
- Analyze and interpret study data.
- Participate in the planning, writing and review of study reports, regulatory updates, and IND and NDA filing activities.
- Assist in planning the overall strategy for clinical drug product development.
- Publish study data and present study data at professional conferences. Serve as the primary medical contact with academic experts, collaborators, and opinion leaders.
- Participate as an active member of multidisciplinary teams to successfully achieve corporate goals. Specific responsibilities include interacting with the Project Management, Microbiology, Biostatistics, Regulatory Affairs, and Clinical Operations departments on a regular basis.
QUALIFICATIONS AND ABILITIES
Five years MD with at least 3 years residency training in internal medicine or pediatrics.
- Sub-specialty training in infectious diseases or microbiology preferred.
- At least two years of industry experience preferred.
- Available for approximately 20-25% domestic and international travel.
- Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
- Proficiency in the implementation, monitoring, and management of clinical trials preferred.
- Proficient in Microsoft Office and Powerpoint.
- Excellent interpersonal, written, and verbal communication skills; clear and concise.
- Understands and effectively responds to multi-cultural communication styles and business practices with alliance partners and internal colleagues.
- Ability to establish excellent collaborative internal and external relationships.
- Works proactively and effectively in a fast-paced, high change environment.
- Flexible; adapts work style to meet organization needs.
- Strong problem-solving, project management, and organizational skills; detail-oriented.
- Willingness to “roll up one’s sleeves” in order to achieve goals.
- Assumes responsibility and accountability for results.
- Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels; discrete.
- Committed to self-development and professional growth; solicits feedback from others.
Notice to Recruiting Agencies and Search Firms:
Cerexa, Inc. prefers to recruit candidates directly, rather than through a third party recruiter or agency. Resumes submitted on this site by unauthorized third parties will not be considered for posted positions and are not eligible for placement fees. All third party agents and search firms must have an approved contract with Cerexa. Inc. to submit resumes on behalf of candidates. No other agreement with any other entity, including Forest, will fulfill this requirement.
If you have a signed agreement with Cerexa, Inc., please contact your Cerexa, Inc. staffing representative who will provide you with the appropriate link to submit your candidate.
How to ApplyTo apply for this position, go to http://www.frx.com/careers/job_description.aspx?number=104314
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