Title: Associate Director, Toxicologist
Req #: 787688
Location: One Stamford Forum, 201 Tresser Blvd, Stamford, CT 06901
Duration: 3-6 months contract to permanent role
Shift Hours: M-F, 9:00 AM to 5:00 PM (8 hours per day)
ASSIGNMENT DESCRIPTION – JOB SUMMARY:
The position requires demonstrated expertise in general mammalian toxicology. The position will oversee the conduct of general toxicity and drug safety studies in accordance with current scientific and applicable regulatory standards (ICH, FDA) and GLPs and will monitor safety studies related to drug registration. The incumbent will be specialized in general safety evaluation including carcinogenicity evaluation and may have experience in one or more of the following areas genetic toxicology, safety pharmacology, reproductive toxicology. He/she is expected to provide leadership in non-clinical drug safety assessment in support of clinical and preclinical R&D. He/she will identify, onboard and direct specialized consultants and CROs to augment capabilities and meet program needs. The incumbent will be required to make both informal and formal presentations to internal staff and project teams and may be asked to assist with presentations to senior management as well as providing project team representation and active involvement in process development. The incumbent will be expected to contribute to the preparation of relevant sections of drug registration submissions. Knowledge of the drug development process and experience in interaction with scientific disciplines such as pharmacokinetics, metabolism, medical research and clinical pharmacology are essential. A successful track record of toxicology testing program management, innovative thinking, execution and timely delivery of reports and regulatory submissions is required.
Direct responsibilities will include, but are not limited to the following:
Lead identification and evaluation CROs (participate in their qualification).
With CRO leads design of study protocols for nonclinical toxicology and safety pharmacology studies for conduct at CROs.
Conduct, monitor, and manage toxicology studies at CROs. This will involve limited travel (~10%).
Reviews study data and reviews/revises final study reports.
With consultants and internal resources leads preparation of the nonclinical safety sections of regulatory submissions including those for registration/marketing authorizations of new drug products
Provide technical expertise to support project teams’ goals and objectives.
ADDITIONAL KNOWLEDGE, SKILLS, AND ABILITIES:
Knowledge and expertise in toxicology and standard and alternative toxicology test methods is necessary to address the range of varied chemical substances that will need to be tested and to interpret and report the study results.
Knowledge of GLPs and substantial direct experience in toxicology testing and/or study management is needed to successfully prepare protocols, implement, and adequately oversee the toxicity studies conducted by CROs and to understand the relative strengths and limitations of testing methods as they relate to hazard identification.
Experience in internet/database searching is necessary to develop information that will allow the avoidance of duplicative and unwarranted use of animals in toxicology testing and to assure up-to-date and complete knowledge of available toxicology data and regulatory changes and initiatives. This includes but is not limited to experience in successfully searching FDA, EMEA, WHO, NTP, ASTDR, IARC, NLM databases.
Ability to pose the right questions and frame key issues related to toxicology/safety issues in a way that optimizes understanding of the issues by others and encourages their input towards resolution.
Correctly interpret complex data from a number of sources and can design and implement follow up studies to clarify/understand issues.
Concise and accurate writing skills and clear and effective oral presentation skills.
Summarize obtained results to discuss with internal staff members
Expected to use independence and initiative to progress studies within aggressive time frames.
Openly communicate issues and propose means/manner to resolve issues to senior management within the Department.
EDUCATION AND EXPERIENCE:
A minimum MS in pharmacology, toxicology, biochemistry or related science is required.
At least 10 years pharmaceutical industry experience.
Able to initiate, maintain and enhance effective interactions with scientific disciplines such as pharmacokinetics, metabolism, medical research and clinical pharmacology. The position is expected to provide back-up for immediate supervision as circumstances dictate.
The position requires specialized training and broad experience which is expected to complement, but not necessarily duplicate, that of others in the department and, therefore, is expected to share technical knowledge, experience, and ‘know how’ with those whom the position interacts.
Demonstrates the ability to serve as an internal and external technical representative between toxicologists as well as between self and interacting departments and senior management. Effectively maintains contacts within internal and external business operations and collaborates with others in the industry to advance pharmaceutical toxicology methodology.
APN Software Services Inc.
Direct: 510-402-1061 | Fax: 510-623-5055 | Amit@apninc.com
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