Head of Pathology and Toxicology
Location: Cambridge, MA
- Provide strategic oversight for toxicology establishing department goals and tactical implementation of plans.
- Oversee quality and performance of all toxicology activities including interactions with alliance partners, CROs and external project support.
- Act as safety lead and ensure pathology support for drug discovery and development stage projects.
- Design and develop approaches for safety assessment of small molecule and antibody therapeutics for oncology drug discovery and development projects.
- Prepare and present internal and external documentation relating to nonclinical safety (e.g. IND, CTA, annual reports and IBs). Negotiate with health authorities worldwide regarding safety issues, scientific interpretation and suitability of sponsor’s data.
- Lead efforts to develop in vitro/in vivo model systems for hypothesis testing of project specific toxicology issues.
- Initiate and facilitate collaboration with academic centers; pharmacology and toxicology consultants as necessary to support internal infrastructure. PhD or DMV in life sciences, toxicology, pharmacology or related field, with extensive industry experience in investigative toxicology and an excellent understanding of early stage drug discovery and development processes.
- Minimum 10 years of pharmacology experience, with a minimum of 7 years in the pharmaceutical/biotech industry, leading and managing drug development setting.
- Proven record in developing submissions for IND-enabling safety studies and regulatory submissions; interactions with health authorities and knowledge of regulatory guidelines regarding toxicology requirements enabling clinical studies.
- Knowledge of current existing guidelines, regulations, requirements and standards (GLP, ISO, OECD, ICH).
- A strong understanding of Oncology is required; experience in small molecule therapeutics required, antibody therapeutics is a plus.
- Board certification in pathology (DACVP) a plus.
- Ability to communicate clearly and effectively with project teams, management and CROs.
- Ability to work in a team environment, meet deadlines and prioritize and balance work from multiple groups.
- Independently motivated, detail oriented and good problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.