$200,000 + (negotiable depending on experience)

We are seeking a Vice President, Toxicology for our Biopharmaceutical client.

This opening is for an individual who will be the spokesperson for the toxicology program . This position will report to the Senior Vice President of Clinical Research and Medical Affairs. Our ideal candidate will have demonstrated leadership, interpersonal, and communication skills as well as strong planning, organization, and decision-making capabilities. This is a unique opportunity to join a successful company during a period of exceptional growth.

Specifically, this individual will:

Represent the Companys toxicology program during presentations to potential partners
Represent the Companys toxicology program during discussions with regulatory agencies
Effectively communicate the relevance and interpretation of study findings to senior management
Represent a non-clinical drug safety evaluation function on multiple project teams
Interact with the scientific staff throughout the company on general matters pertaining to toxicology
Compose and edit relevant sections of regulatory and scientific documents
Provide technical expertise to support project team goals and objectives
Be familiar with development and execution of non-clinical safety drug development plans for novel therapeutics
Be familiar with support functions involving toxicological concerns in other areas including formulations, drug supply, analytical, and bioanalytical work
Be familiar with CRO oversight, including negotiation of contracts, and the review and approval of protocol, study data, and study reports


Minimum job requirements include:

A PhD in toxicology with expertise in mechanistic approaches to understanding drug toxicity
10+ years of experience in the pharmaceutical industry or in combination with an academic career
Familiarity with regulatory requirements with regard to the toxicology components of IND and CTA submissions
Familiarity with designing, executing, monitoring, and reporting nonclinical safety studies
Experience in writing and reviewing relevant sections of regulatory submissions
Excellent written and verbal communication skills
In-depth knowledge in pharmacology, toxicology, and FDA regulations related to pharmaceutical products safety assessment, including thorough knowledge of US and ICH guidelines


Required Skills: A PhD in toxicology with expertise in mechanistic approaches to understanding drug toxicity. Familiarity with regulatory requirements with regard to the toxicology components of IND and CTA submissions Familiarity with designing, executing, monitoring, and reporting nonclinical safety studies

Desired Skills: In-depth knowledge in pharmacology, toxicology, and FDA regulations related to pharmaceutical products safety assessment, including thorough knowledge of US and ICH guidelines

Years Experience Required: 10+

Non-Technical Skills: Experience in writing and reviewing relevant sections of regulatory submissions
Excellent written and verbal communication skills

Please email your resume and cover letter to ruth@pharmacruiting.com

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