Director of Pre-Clinical Development
Location : Princeton NJ US 08540
Job Type : Direct
Reference Code : 19870-AB1
Compensation : 100000.00 - 150000.00 USD/YEAR
Start Date : 07/08/2019
Hours : Full Time
Required Years of Experience : 10
Required Education : PhD Toxicology or Pharmacology
Travel : No
Relocation : No
Job Industry : Biotechnology
Job Description :
- Permanent position for a Director of Pre-clinical Development to lead development, execution, design, interpretation and presentation of toxicology, PK / PD, ADME, and pharmacology in vivo and in vitro studies to support pipeline.
- This is a growth opportunity to ultimately lead a department at an expanding biotech company in the Princeton area.
- Support rapidly growing portfolios for pre-clinical development and IND application for small molecules in oncology.
- Develop solid and efficient pre-clinical programs and address and resolve scientific issues arising in pre-clinical development.
- Review drug candidates' profiles with regards to toxicology, PK/PD, ADME and pharmacology to serve as a SME, providing insights into strategies and studies, and efficiently applying science and technology.
- Ensure compliance with government authority requirements for pre-clinical development programs using a strong knowledge of FDA, EMA, ICH and GLP guidelines.
- Interface with CROs for pre-clinical development studies. Monitor design, protocol, execution, timeline, quality, progress, data analysis / interpretation, and reports review.
- Support regulatory submission (eCTD for IND and NDA), briefing books (BB), response documents for health authority interactions and address questions/requests, as well as annual update (e.g. IB).
Required Qualifications :
- Ph.D. in Toxicology, Pharmacology, DMPK or related scientific discipline (DABT certification preferred).
- At least 10 years of pharmaceutical / biotech industry Toxicology / TK, PK/PD experience. At least 3 years of director level experience.
- Must have experience in oncology and small molecule preclinical development. Cancer metabolism strongly preferred.
- Extensive experience in strategic planning, program design, project and budget management.
- Strong expertise in TK, PK/PD, M&S (modeling and simulation), ADME, pharmacology, and allometric scaling from animals to human.
- Hands-on experience in managing and working with CROs.
- Passionate and self-motivated with strong leadership, management, communication, negotiation, presentation and teambuilding skills.
- Familiar with international regulatory guidelines.
Contact: Allan Berman
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