The Head of Preclinical Sciences is responsible for overseeing the drug metabolism, pharmacokinetics and toxicology support for development candidate nomination and IND filings. Qualified candidates will be creative and detail-oriented with a passion for drug discovery, possess excellent project management, time management, communication, data analysis, and interpersonal skills, along with an overall understanding of, and direct hands on experience, in early-stage development within the biotech/biopharma industry. This position will report to the Vice President, Biology.
Activities include, but are not limited to:
- Collaborate with research project leaders to develop project-specific strategies to generate appropriate data to support development candidate nomination and IND filing
- Oversee the design and management of pre-clinical studies (GLP and non-GLP) for inclusion in IND submissions, including ADME/PK and biodistribution and toxicology
- Oversee the selection and management of consultants and contract research organizations (CROs) to support pre-clinical development programs
- Manage projects conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, review of data and draft study reports, completion of contract milestones, study close-out and alignment of preclinical development efforts with corporate drug development efforts and priorities
- Write and edit pre-clinical study reports
- Oversee drafting of the relevant sections and individual reports to support regulatory filing including pre-IND, IND, IB, and clinical lab manuals
- Participate in discussions with FDA to obtain feedback on pre-clinical development programs
- Contribute to clinical development plans
- Ensure compliance with global pre-clinical studies regulatory guidelines
- PhD or DVM and post-doctoral experience in Pharmacology, Drug Metabolism, Toxicology or Pathology and knowledge of biochemistry, cell biology, systems biology, and physiology.
- Solid understanding of the drug discovery and development process based on at least 7-10 years of relevant experience in the biotech/pharmaceutical industry
- Demonstrable contributions to regulatory filings and working knowledge of GLP, GCP and ICH regulations
- Experience with the design and execution of in vitro/in vivo experiments to determine the effects of therapeutics on biological systems, with line of sight to human safety risk understanding.
- Hands-on experience with in vitro toxicology, pharmacology and/or molecular biology experimentation to investigate molecular mechanisms of drug action.
- Strong leadership competencies and management experience, including selecting CROs and overseeing the relationship.
- Excellent written and oral communication, presentation and influencing skills Highly motivated, creative, innovative, reliable scientist, with a flexible, collaborative, team-oriented mindset, who solves problems in a goal-focused fashion and can excel in a fast-paced small company environment
- A social personality that contributes to an open, positive, collaborative working climate.
- DABT certification and experience as GLP Study Director is preferred, but not required.
- Working knowledge of human dose modeling
New Haven, CT
Please send CV and cover letter to: email@example.com.