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We are an EasyHiring recruiting company that is looking for our partners candidates for the position of Scientific Executive Director, Nonclinical Safety in Sayreville, NJ for work in the city of New Brunswick, NJ

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Position: Scientific Executive Director, Nonclinical Safety

The Nonclinical Safety and Veterinary Sciences organization enables the safe conduct of clinical studies and marketing applications while applying the core underlying principles of robust science & problem solving, 3R’s (reduce, replace, and refine), animal welfare, and quality & compliance to our nonclinical efforts. While focusing on transforming patients’ lives through science, we intend to be an industry-leading nonclinical safety evaluation, laboratory animal science and medicine organization with high scientific, quality, & employee safety standards.

In the role as an Executive Director of Nonclinical Safety, the ideal candidate:

• In the role as an Executive Director of Nonclinical Safety, the ideal candidate:
• Ensures the compliance of Nonclinical Safety studies with departmental SOPs, worldwide regulatory requirements, and Good Laboratory Practice Regulations. Maintains knowledge of worldwide testing and registration requirements.
• Oversees the scheduling, proper design, efficient execution, and timely reporting of toxicity studies in support of drug development both internally and at CROs to ensure timely and unencumbered clinical testing and registration of drug candidates.
• Provides oversight of operations, staff, budget, outsourcing strategy, and facilities for Nonclinical Safety
• Anticipates future trends and develops new and innovative research
• Acts as a subject matter expert that works independently on deliverables and exercises foresight and judgement in planning and structuring complex project work
• Provides in-depth analysis and recommendations to senior management in complex situations
• Makes decisions that impact the objectives and reputation of the function, and ultimately the business
• Acts as a significant figure in creating and sustaining a culture of responsible risk taking and curiosity
• Creates alliances across disciplines and leads the decision-making process for completion of team goals
• Seeks to identify collaborations within and outside of the company
• Provides effective coaching and feedback to help develop team members and colleagues within and outside of department
• Is recognized as an influential authority across the company and in the external community
• Directs, coordinates, and integrates the nonclinical safety evaluation of drug candidates.
• Provides key scientific leadership at the department and organizational levels across all therapeutic areas to ensure effective safety assessments of drug candidates and to enable key decisions on the portfolio.
• Provides the necessary scientific/development expertise and strategic leadership in identifying and resolving nonclinical safety issues.
• As a member of the NCSVS leadership team, represent function while exhibiting an enterprise mindset.

Experience:

Basic Qualifications:

• Master’s Degree with 20 years of academic and / or industry experience or
• Ph.D. or equivalent advanced degree in the Life Sciences with 15 years of academic and / or industry experience
• 10 years of leadership experience preferred

Preferred Qualifications and Experiences:

• Ph.D., or equivalent advanced degree in the Life Sciences, preferably Pharmacology/Toxicology
• 15 years of industry experience
• Extensive knowledge of regulatory and pharmaceutical industry nonclinical safety practices
• 10 years of leadership experience
• Excellent managerial and leadership skills, overseeing complex and cross-functional teams
• Excellent verbal and written communication skill as well as organizational skills
• Extensive experience overseeing strategic, scientific, and operational aspects of toxicology testing of pharmaceuticals
• Extensive regulatory toxicology experience, including submission of regulatory documents (eg, INDs, CTAs, NDAs, and BLAs), knowledge of global and regional (including US, EU, Japan, and China) pharmaceutical industry regulations, and interactions with global Health Authorities

Job Type: Full-time

Work Location: In person