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Sangamo BioSciences,
Inc. (Nasdaq: SGMO) is a biotechnology company
focused on the research, development and commercialization
of ZFPs for gene regulation
and gene modification.
Sangamo provides a friendly and casual work environment
that is intellectually inspiring and professionally
stimulating. Sangamo has excellent growth opportunities
for highly qualified and motivated individuals.
We offer competitive compensation and benefits; Health,
Dental, Vision and Life insurance, 401(k), Employee
Stock Purchase Plan, and a 125 cafeteria plan. Successful
candidates will have the opportunity to join a dyanamic
team and become a key player in the development of
a powerful technology into a novel therapeutics platform.
Job Openings
The following is a list of open positions with Sangamo BioSciences. (Updated 05/18/2010)
Lead Clinical Research Associate
Senior Clinical Research Associate
Clinical Research Associate III
Clinical Manager
Regional Clinical Research Associate Monitors
Scientific Programmer (Programmer / Analyst I)
Lead Clinical Research Associate
Essential duties and responsibilitites include, but are not limited to the following:
Ensure that Regional CRAs are performing their duties and responsibilities
Conduct regular meetings with the Regional CRAs
Act as liaison for the Regional CRAs and in-house CRAs
Provide periodic reports to Clinical Development Management
Recruit investigators for participation in clinical trials
Conduct project feasibility assessments
Negotiate study budgets with investigators
Review and process regulatory documents from sites
Coordinate shipment of study-related materials
Review protocols for completeness and feasibility
Develop Case Report Forms for clinical trials
Assist in the preparation and presents at Investigator’s Meetings e.g study-specific guidelines and procedures, CRF and monitoring conventions
Prepare project management reports for clients and internal management
Train Regional CRAs on monitoring, internal procedures and query resolution.
Take responsiblity for the planning and delivery of the assigned critical component of the study in accordance with the scope of work and contracted timelines
Maintain correspondence with principal Investigators and Study Coordinators regarding auditing results and changes, if any, which need to be made
Develop monitoring strategy and review for approval with Clinical Development management
Assist in vendor management
Review trip reports, conducts performance reviews and submits performance evaluation reports to management.
Provide monitoring assistance when necessary e.g. absence of a Regional CRA, critical phase of the study such as data cut and database lock.
Contribute to clinical sections of final study reports and regulatory submissions
Other duties and responsibilities expected from a Lead CRA
Requirements for a Lead CRA:
Minimum of a BA/BS degree in nursing, pharmacy, life sciences or health-related discipline
Master's degree preferred
Minimum of 5 years of field monitoring experience from a biotechnology/pharmaceutical company from site qualification, inititation to close-out in accordance with regulatory requirements
Thorough knowledge of GCP, ICH and FDA regulations in conducting clinical trials in human subjects
Minimum of 3 years experience as a Lead CRA
With 3-5 years of experience in conducting clinical studies involving Diabetes Mellitus preferably in subjects with diabetic neuropathy
Experience in managing vendors
Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment
Self-motivated, assertive and able to function independently or as part of a team
Strong written and verbal communication; strong interpersonal skills
Proficiency in Microsoft Office applications (Excel, Work, PowerPoint, Access and Outlook) Viseo, WebEx, eClinical Management System (CDMS, CTMS, IVRS, EDC, eCRFs, etc.)
Ability to travel as required
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Senior Clinical Research Associate
Essential Functions include but are not limited to the following:
Assist in the design, planning and implementation of clinical research projects, including drafting project plans and timelines as needed
Manage the development of protocols, Investigator Brochures, case report forms, informed consents, study manuals and study budgets
Negotiate and finalize site contracts and budgets, manage and calculate site payments
Perform site visits including site qualification, initiation, monitoring and close-out visits
Hire, train and supervise regional monitors and review monitoring reports
Ensure sites comply with study protocol (to ensure accurate and complete data collection) and federal regulations
Represent Sangamo BioSciences in a professional manner; establish and maintain good relationships with investigators and study site personnel
Maintain frequent site contact; and prepare, track, and manage required study documentation and supplies
Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents)
Review data listings on an ongoing basis
Determine and oversee site drug requirements and accountability and other supply requirements
Plan and coordinate Investigator Meetings
Assist in preparing interim study analyses, annual reports, and clinical study reports
Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS)
Reviews draft statistical reports for accuracy and consistency
Manage overall study budget
Mentor and train junior Clinical Research Associates
Requirements
5 to 7 years of experience in planning and overseeing clinical trials for a biotech company
BA/BS degree in a nursing, pharmacy, life sciences or health-related discipline
Demonstrated ability to independently supervise a clinical trial from initiation to close, in accordance with regulations and with company policies and procedures
Thorough knowledge of GCP, ICH and FDA regulations
Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment
Self-motivated, assertive and able to function independently or as part of a team
Strong written and verbal communication; strong interpersonal skills
Ability to travel 30-40%
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Clinical Research Associate III
Essential functions include, but are not limited to the following:
Assist in the design, planning and implementation of clinical research projects
Manage the development of protocols, Investigator Brochures, case report forms, informed consents, study manuals and study budgets
Negotiate and finalize site contracts and budgets, manage and calculate site payments
Perform site visits including site qualification, initiation, monitoring and close-out visits; co-monitor with regional monitors and review monitoring reports
Ensure adherence to the protocol providing for accurate data collection, documenting drug accountability and compliance with federal regulations
Represent Sangamo BioSciences in a professional manner; establish and maintain good relationships with investigators and study site personnel
Maintain frequent site contact; prepare and track required documentation and manage study supplies at clinical sites
Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents).
Review data listings on an ongoing basis
Assist in planning Investigator Meetings
Assist in preparing interim study analyses, annual reports, and clinical study reports
Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS)
Requirements
4 to 5 years of Pharmaceutical industry experience including direct site management
BA/BS degree in nursing, pharmacy, life sciences or health-related discipline
Thorough knowledge of GCP, ICH and FDA regulations
Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment
Self-motivated, assertive and able to function independently or as part of a team
Strong written and verbal communication; strong interpersonal skills
Ability to travel 30-40%
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Clinical Manager
Essential functions include, but are not limited to the following:
Ensure that management’s clinical development objectives are met
Provides assistance in the strategic and operational direction, planning, execution and interpretation of clinical programs and data collection
Implement and manage assigned clinical programs and clinical studies. This includes writing of study protocols, informed consents, case report forms, study reports and summaries, monitoring plans, investigators brochures and other study-related documents that may include IND, NDA, BLA etc,.
Independently evaluate and recommend selection of investigators/study sites; actively participates in the identification of potential sites
Independently train investigators, coordinators and other trial staff in data collection methods to ensure collection of study subjects data is accurate, complete and conforms to project data standards and protocol requirements
Manage study and/or program budgets and timelines including clinical site budget and contract negotiations
Assist management in resource planning
Responsible for directing, managing, training and performance evaluation of direct reports.
Responsible for ensuring SOP and regulatory compliance of staff and clinical sites in assigned clinical programs
Responsible for CRO selection, development of RFPs, budget negotiations and managing CROs in assigned clinical programs
Provides assistance to the CRO in the development of Statistical Analysis Plan, Data Management Plan and Quality Control Plans
Responsible for projecting and managing investigational drug supply use for assigned clinical sites
Monitor and close-out clinical studies, ensuring adherence to protocol, accurate data collection on CRFs via comprehensive source document verification
Develop solutions for logistical and operational issues that arise during trial execution and communicate these in a timely fashion to investigators, coordinators and staff
Ensures that written reports for product complaints and serious unexpected events are properly identified and reported appropriately
Responsible for the development of SOPs, systems and policies supporting clinical studies
Maintain a high level of professional expertise through familiarity with clinical literature and participates in project team meetings
Attends scientific meetings, as necessary and required
Background Qualifications:
Bachelor’s degree in a relevant scientific discipline is required
Experience managing CRO’s
At least 8 years of relevant clinical experience in the biotech/pharmaceutical industry or equivalent with a solid track record of managing effective teams
Knowledge of FDA regulations, GCP and ICH guidelines required
Excellent communication and interpersonal skills
Able to lead teams and motivate team members
Able to prioritize and handle multiple tasks
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Must be willing to travel as required
Other Knowledge and Skills Required:
Experience in and strong understanding of clinical trial design
Strong team player. Ability to work independently and in a multidisciplinary project team environment, including interactions with external vendors and CROs
Attention to detail, accuracy, and strong organizational and problem-solving skills
Leadership skills as well as demonstrated clear and concise verbal and written communication skills. Ability to influence others effectively
Ability to skillfully manage competing priorities and projects and handle multiple tasks simultaneously
Dedication to quality and reliability in all work tasks
Self-motivation, eagerness to grow professionally and commitment to self-development
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Regional Clinical Research Associate Monitors
Regional CRA Monitor 1: Covering ME, VT, NH, RI, CT, MA, NY, PA, MD, DC, VA, WV, OH, KY, and TN.
Regional CRA Monitor 2: Covering NC, SC, GA, FL, AL, MS, LA, AK, OK, and TX.
Regional CRA Monitor 3: Covering IN, IL, MI, WI, MN, IA, ND, SD, NE, and KS.
Regional CRA Monitor 4: Covering CA, WA, OR, NV, ID, UT, MN, WY, CO, AR, and NM.
Essential duties and responsiblities include, but are not limited to the following:
Monitor (pre-study, initiation, routine and close-out visits) at investigator sites of primary regional assignments for GCP compliance and according to Sangamo’s SOP’s and/or client guidelines
If necessary and when directed, monitor other regions to assist in the monitoring activities during critical phases of the study such as data cut or database lock
Assist in negotiating study budgets with investigators
Verify Case Report Form information with source documents to reconcile any data entry queries; resolve queries of CRF data with study site personnel
Review site study file for completeness and correct information including IRB related documents
Verify that Informed Consent process was conducted properly and advise the site personnel of any execution issues
Perform drug accountability and reconcile counts with CRF, source data and dispensing logs
Obtain information that will assist in the processing of Serious Adverse Event (SAE) reports, according to Safety Monitoring Plan
Obtain and review for appropriateness regulatory and administrative documents from investigator sites
Oversee and evaluate subject enrollment
Compile and review subject status-tracking information
Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports
Respond immediately to site questions, issues and requests
Ensure that any site issues are communicated immediately to the Lead CRA and/or Clinical Trial Manager.
Respond to other requests related to clinical study activities.
Requirements for Regional CRA Monitor:
BA/BS degree in pharmacy, nursing, life sciences or health-related discipline.
Demonstrated ability to independently perform monitoring activities from initiation to close-out in accordance to regulatory requirements and company policies and procedures
Thorough knowledge of GCP, ICH and FDA Regulations in conducting clinical trials in human subjects
Minimum of 3 years of field monitoring experience for a biotech/pharmaceutical company
With 2-3 years of experience in conducting clinical studies involving Diabetes Mellitus preferably in subjects with diabetic neuropathy
Detail oriented, able to multi-task and work effectively in a fast-paced environment
Self-motivated, assertive and able to function independently or part of a team
Strong written and verbal communication
Proficiency in Microsoft office applications (Excel, Word, power Point, Access and Outlook), Visio, WebEx, eClinical Management System(CDMS, CTMS, IVRS, EDC, eCRFs, etc)
Ablity to travel within regions of assignment
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Scientific Programmer (Programmer / Analyst I)
Sangamo seeks a talented computer programmer (or scientist with exceptional programming skills) to fill an open position in our Technology group. The successful candidate will work with the group to improve our core protein design platform and related bioinformatics tools. Critical activities will include maintenance of our relational databases, data mining for patterns and trends, and the development of custom analysis scripts and web-based tools. The position requires adaptability, creativity and a capacity for constant innovation in pursuit of company goals. The work is exciting, fast-paced and directly impacts the company’s scope and capabilities.
Requirements:
B.S. in computer science, biology, chemistry or related field
Proficiency with python (or proficiency with PERL, JAVA or C/C+ and the ability to learn python)
A demonstrated proficiency in bioinformatics (i.e. a degree, a relevant scientific publication, or work experience)
Familiarity with UNIX-based operating systems
Strong written and oral communications skills
An ability to work in a team-oriented, multidisciplinary environment.
Additional attractive qualities include:
A graduate degree in computer science, biology, chemistry or related field
The ability to program in R or other statistical computer languages
Experience with relational databases
Experience with web-based applications.
If you feel you are qualified for this position, please send a cover letter and your resume / CV in electronic form to jobs@sangamo.com
.
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Requirements are consistent with position levels and duties.
Salaries are commensurate with experience levels.
In addition to a competitive salary and excellent benefits, Sangamo offers stock options.
Sangamo is an equal opportunity employer.
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