Director, Safety and Pharmacology Promedior
THIS JOB HAS EXPIRED Reports to: Chief Scientific Officer
Education: M.S. or Ph. D. in Pharmacology, Toxicology or related discipline
Experience: Minimum of 10 years experience with Ph.D., or equivalent experience. Established reputation in managing preclinical GLP safety studies, Pharmacokinetic studies and Pharmacodynamic studies and proven project management skills
The successful candidate will have an established record in design and management of safety and pharmacology studies related to recombinant proteins and protein therapeutics. The candidate must be results driven, and make independent decisions on the basis of data using sound scientific methods in order to keep projects on track and on time. This person will lead and manage the conduct of all safety/toxicology studies and pharmacokinetic studies with third party CROs, as well as assist the CSO in management of pharmacology studies with academic colaborators and third party CROs. An in-depth understanding of the regulatory requirements for development of protein therapeutics is essential as is direct experience in authoring and submitting safety/toxicology and pharmacology regulatory documents to support clinical development. This position requires strong leadership and problem solving skills as well as excellent communication skills in English, particularly with respect to the analyses required for therapeutic protein drug development and manufacuturing support. This person must have an in-depth understanding of the analytical methods used to support safety assessment and immunogenicity of recombinant protein therapeutics. Ideally, the candidate will have direct experience in pulmonary, oncology and/or ophthalmic drug development.
This person will assist in evaluation and management of CRO organizations and make recommendations as to their suitability for non-GLP and GLP toxicology studies. This person must be comfortable working independently in a small company environment and balancing internal work with outside contractors to complete PK, PD and safety assessments.
In-depth knowledge of complete ADMET assessment of protein therapeutics for clinical development and hands-on experience executing GLP safety studies, PK studies and pharmacology/PD studies in multiple species, with an in-depth understanding of the technical and regulatory issues relevant to such analysis
In-depth knowledge of the issues related to protein drug development as it applies to PK and Immunogenicity testing
A strong working knowledge of relevant US and European drug development regulations, with demonstrated experience in authoring and submitting safety and pharmacology regulatory documents, including successful review by relevant authorities (FDA and EMEA).
Demonstrated capability of proficient written and oral communication skills in English
Ability to work in a small company
The ability to supervise both junior and senior level scientists including coordinating their activities in order to meet company goals and timelines
||Boston, MA |
THIS JOB HAS EXPIRED