Title: Associate Director, Preclinical Studies - 4809-jbf
Position Summary:
This person will direct the activities of the preclinical development group to promote animal efficacy and safety testing of candidate therapeutic products derived from human embryonic stem cells. Studies in animal models for cardiovascular, endocrine, central nervous system and skeletal diseases are anticipated. This person will both manage and have hands-on responsibility for the design and execution of preclinical animal studies including data analysis and report writing.
Responsibilities:
Direct and actively participate in scientific studies to address proof of concept and safety testing of Geron’s human embryonic stem cell based products in animal models. Studies will be performed internally, as well as with contract and academic research laboratories.
Manage and coordinate activities of the preclinical group to address the needs of multiple development programs.
Select and manage CROs as necessary for project needs.
Provide functional and technical management to scientific personnel within the group.
Perform data analysis and generate reports, including those for regulatory filings.
Write and review manuscripts for publication.
Collect, interpret, discuss and present data for project teams, senior management, and externally, as appropriate.
Represent the preclinical group in project teams to help design studies to meet program goals and provide coordination across groups.
Work with clinical development teams to design and execute animal studies to address specific medical needs of Geron’s products.
Maintain an up-to-date understanding of scientific developments within related fields.
Coordinate preparation of progress reports and internal documentation.
Qualifications:
The ideal candidate will have a Ph.D. in Pharmacology or a related field, with a minimum of 10 years post-doctoral experience.
The candidate will have demonstrated managerial skills with previous experience in a management role in the biopharmaceutical industry desirable.
Experience conducting physiological, behavioral and anatomical efficacy measures using preclinical models of disease is required.
Direct experience with animal surgery is required.
The candidate must be detail oriented and highly conscientious. He or she must have strong organizational skills, and a well-developed ability to multi-task.
The candidate should demonstrate successful prior direction of complex, interdisciplinary projects and participation in project teams; familiarity with biologics preferred.
The candidate must have excellent communication capabilities and presentation skills.
The successful candidate will be able to work independently, as well as contribute to an integrated team. He or she must be able to interact with a broad range of colleagues within Geron.
Previous experience with preparation of regulatory submissions and familiarity with GLP regulations are desirable.
The candidate must be willing to travel, occasionally for periods up to 2-3 weeks.