Group Leader/Associate Director, Preclinical Development (Job Code 4809)
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.
Product Development - Cell Therapies
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Clinical Operations
Medical Director/Clinical Scientist, Oncology (Job Code 4909)
Geron is seeking a Medical Director/Clinical Scientist with drug development experience to join the Oncology program. The candidate should have an M.D. with board certification/eligibility in hematology/oncology, or PhD/PharmD with at least 3 years of drug development experience. Prior experience of clinical trials in an oncology related field is preferred. Candidates must be comfortable proactively solving issues and working independently.
Job Duties and Responsibilities are primarily focused, but not restricted to the design, implementation, analysis and interpretation of clinical trials from phase I-III. The post-holder will be expected to make a significant contribution to the strategic direction of the Oncology programs, including clinical trial design, implementation, analysis, interpretation and dissemination of results as detailed below. In addition the post-holder will be required to build and maintain excellent relationships with outside parties including clinical investigators and advisors, regulatory authorities and other Government institutions (eg NCI), and collaborating companies.
Responsibilities:
Design:
Design of clinical experiments, including drafting of protocol summaries and providing clinical input to complete protocols
Provide initial clinical designs for future trials including partnering with research, translational oncology, biostatistics, clinical operations, regulatory and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings
Serve as a key member on the Clinical SubTeam. Provide significant input into the clinical development/strategy
Implementation:
As Medical Monitor, to be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines
Partner with Data management for CRF and Tables, listings and figures design and data quality plan
Medical monitoring of Phase I-III trials including serving as the primary Clinical Science contact on the Protocol Execution Teams(s) and the primary liaison for clinical operations and the primary point of contact for Medical Monitor inquiries from sites, monitors and CROs
Perform regular clinical review of listings and partner with clinical operations/drug safety to develop a safety monitoring plan
Analysis and Interpretation:
Analysis of interim and final data, including interpretation and representation/explanation of the results in verbal and written format within and outside the Company
Competencies:
Excellent technical understanding of oncology
Excellent technical understanding of the clinical trial process and in particular the role of the Medical Monitor, including compliance requirements, ICH, etc
Excellent written and verbal communication skills
Ability to work well as part of multi-disciplinary teams
Medical Safety Scientist/Director, Pharmacovigilance (Job Code 0510)
The Medical Safety Scientist will establish the direction and priorities of Clinical Pharmacovigilance for the clinical development programs within Geron Oncology, and will be responsible for product safety-related decisions and recommendations to the Chief Medical Officer for assigned Oncology clinical programs. Responsibilities include, but are not limited to:
Timely communication of safety recommendations and/or actions to internal and external stakeholders
Lead or co-lead responses to regulatory enquiries regarding safety
Lead development of strategy and creation of product risk assessment profiles including maintenance and updates
Manage quarterly product safety review execution and implementation of recommendations
Responsible for clinical safety content of clinical protocols and Investigator?s Brochure
Contribute to and sign off on appropriate data review and data reconciliation reports
Represent Medical Safety at meetings with Regulatory authorities
Participate in planning, review and sign off of clinical trial safety documents and aggregate safety reports (e.g. PSURs, ASRs)
Responsible for identification, assessment, and communication of potential safety signals
Basic Qualifications:
Medical Degree (MD or DO) from an accredited WHO medical school
Completion of an accredited medical or surgical residency
Board eligible
Clinical experience in either an accredited academic setting or private practice (including hospital-based) setting
OR:
PharmD or equivalent with clinical experience in Oncology and with extensive previous drug safety experience in industry (biotech or pharmaceutical)
Preferred Qualifications:
Previous management experience
General competencies required:
Excellent technical understanding of clinical oncology
Excellent written and verbal communication skills
Ability to work well as part of multi-disciplinary teams
