Welcome to Careers at SillaJen

OPENINGS

SillaJen is an exciting, fast paced environment for individuals who are looking for a new challenge and want to work with an exceptional and supportive team. We are a small group of professionals who share a belief that we can offer better treatments for cancer patients. We are dedicated to moving our investigational product through clinical trials and into the market.

We offer competitive salaries and a full suite of benefits including:

  • Medical (HMO, PPO, Kaiser), Dental and Vision. Employer sponsors 90% of employee premium and 70% of dependent premium.
  • 100% Employer paid Life Insurance, Long Term Disability and Short Term Disability
  • Company stock options
  • Bonus Plan
  • 401k Plan
  • Flexible Spending Accounts
  • Commuter Benefit program
  • 3 Weeks Vacation per year
  • Up to 72 hours sick leave per year
  • 11 paid holidays per year

We are located in the heart of San Francisco’s Financial District with easy access to BART, Caltrain, SFMuni, Golden Gate Transit, AC Transit and the Ferry Building. Together we celebrate birthdays, enjoy holiday parties and attend offsite events, host “lunch and learn” meetings, and fuel our minds with healthy snacks and beverages from our fully stocked kitchen.

Openings

Clinical Trial Assistant I/II or Clinical Research Associate I/II Sillajen, a privately held biotech company, is seeking an entry-level or mid-level clinical trial assistant or an in-house CRA I/II level to assist with the coordination of vendor and site management activities within clinical operations.

The ideal candidate will be a self-starter who is proficient with MS Office (Excel and PowerPoint in particular) software. The candidate should have at least a familiarity with how clinical trials are conducted, but prior experience working in a small to midsized biotech is preferred. This is an in-house, office based position. The SillaJen office is located in downtown San Francisco (Financial District) close to BART, MUNI, and Parking facilities.

Primary Responsibilities and Duties:

  • With minimal supervision, provide administrative support to the Project Management and Medical teams by maintaining the study materials folder, including: site training documents, site reference binders, study presentations, CRA training material, etc.
  • Under the guidance of the Sr. Director, Clinical Operations, track site educational visits from the medical science group, including: visit coordination tasks (administrative), tracking of documentation from visits, copying and filing documents and reports, and providing metrics to the Dir. Of Clin Ops and other management as required
  • Under the guidance of the Sr. Director or Sr. PMs, track vendor management activities within clinical operations including: uploading of site visit reports, scheduling of co-monitoring visits, receiving, copying, and filing documentation of this review, and providing metrics to Sr. Director and management staff as required
  • Tracking and recording invoices received from clinical trial vendors, and working with the Dir. of Clin Ops on quarterly budget review
  • Assists the clinical study team with site essential regulatory document collection, review of essential documents, and release of IP for use in a clinical trial and ensures that critical site documents and correspondence are maintained in the CRO eTMF per contract
  • Ensures timely entry and updates to clinicaltrials.gov
  • Assists with the tracking of clinical trial progress and ensures that vendor trackers and updates are provided to the clinical team
  • Assists with the development and review of clinical trial documents as assigned such as: ICF, eCRF, paper CRF, site training documents, etc.
  • Participates in clinical team meetings and interacts in a positive, professional manner. May coordinates meetings/teleconference/WebEx. May be asked to prepares agendas, minutes and tracks action items.
  • Maintains completion of required corporate training on standards, policies, work instructions by due date
  • Identifies and escalates issues appropriately
  • Performs other work-related duties as assigned

Requirements

Qualifications:

  • Understanding in relevant clinical operations activities
  • Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations required
  • Working knowledge of TMF maintenance and management of essential documents
  • Solid interpersonal, written and verbal communication skills across study team including study management
  • Desire to work within a small remote-team environment. Must be a self-starter and able to work under limited supervision
  • Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, Outlook, and organization tools
  • Experience with filing systems such as Sharepoint, Dropbox, Box, or Soonr is desirable
  • Attention to detail and accuracy in work
  • Effective time management and organization skills
  • Ability to multi-task under limited direction and on own initiative
  • Performs other work-related duties as assigned

Education and Experience Typically Required:

  • BA/BS or equivalent degree in a scientific discipline or related field is preferred but not required
  • 1-3 years experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting is required
  • Demonstrate basic understanding of medical terminology and clinical activities
  • Demonstrate computer proficiency with MS Office Suite products
  • Level and salary will be commensurate with experience
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Sillajen, a privately held biotech company, is seeking an entry-level or mid-level drug safety associate to Assist with the coordination of all pharmacovigilance activities within the drug safety department along with assisting as needed in clinical operations.

This is an in-house, office based position. The SillaJen office is located in downtown San Francisco (Financial District) close to BART, MUNI, and Parking facilities.

  • Assist with tracking and review of all adverse event reports received from PVG vendor
  • Conduct evaluation of incoming case reports and source documents for completeness, accuracy, legibility, and consistency
  • Maintain privacy of confidential patient information and adhere to blinding plan during case review
  • Assist with case management activities to ensure compliance with departmental and regulatory timelines and quality standards
  • Monitoring of safety inbox on a daily basis, filing and maintenance of all safety related correspondences and documents
  • Support SillaJen’s Global Safety Database activities, generation of aggregate safety reports (DSUR, PADER)
  • Support signal detection and risk management activities
  • Support development of Safety Management Plans (SMPs), Standard Operating Procedures (SOPs), and other procedural documents as needed
  • Collaborate with internal and external stakeholders to facilitate the conduct of clinical studies and post marketing activities
  • May perform other duties as assigned in operations and regulatory, including periodic travel within North America or internationally (under 25% time)

Requirements

  • Understanding in relevant drug safety and clinical operations activities
  • Good working knowledge and understanding of ICH/GCP guidelines and FDA regulations required
  • Working knowledge of TMF maintenance and management of essential documents
  • Solid interpersonal, written and verbal communication skills across study team including study management
  • Desire to work within a small remote-team environment. Must be a self-starter and able to work under limited supervision
  • Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, Outlook, and organization tools
  • Experience with filing systems such as SharePoint, Dropbox, Box, or Soonr is desirable
  • Consistent attention to detail and accuracy in work
  • Effective time management and organization skills
  • Ability to prioritize, plan and multi-task under limited direction and on own initiative under strict timelines
  • BA/BS or equivalent degree in a scientific discipline or healthcare related field
  • 1-3 years’ experience in drug safety or in the pharmaceutical, biotechnology, CRO and/or healthcare setting is required, an equivalent combination of relevant education and applicable job experience may be considered
  • Intermediate to advanced knowledge in pre- and post-marketing pharmacovigilance
  • Demonstrate solid understanding of medical terminology and clinical activities
  • Experience using MedDRA and WHO-DD
Apply Now