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If you share our passion for advancing new medicines to benefit patients with virus-associated cancers and other serious diseases please submit your resume or CV to humanresources@viracta.com.

Open Positions 



Associate Director/Director Clinical Pharmacologist

Job Summary:

  • The Clinical Pharmacologist will contribute to the development and/or optimization of proprietary drug candidates by providing pharmacokinetic and toxicokinetic evaluation in non-clinical and clinical studies.
  • This team member will provide oversight to relevant CROs and consultants in conjunction with the R&D leadership. 

Duties/Responsibilities:

  • Establishing pharmacokinetic testing strategies and analyzing pharmacokinetic-related data generated during clinical trials, providing summaries as requested.
  • Thorough understanding of pharmacokinetic principles, including in-life aspects, modeling procedures (e.g., noncompartmental and compartmental), and interpretation of pharmacokinetic data
  • Development and characterization of bioanalytical assay systems to be used in pharmacokinetic studies
  • Identifying suitable CROs for PK studies, establishing good working relationships and installing contracts for respective studies
  • Supervising monitoring of contracted pharmacokinetic studies as well as data interpretation
  • Provides strategic and scientific advice regarding DMPK to Peer Review Committees and   Senior Leadership
  • Reporting of pharmacokinetic studies including integration of results in summary documents (e.g. IB, NDA and IMPD)
  • Planning, monitoring and reporting of studies on time, on budget and by meeting highest scientific and regulatory quality standards
  • Represent the PK/PD/ADME discipline on project teams
  • Responsibility for PK assessments in toxicology and clinical studies and managing related activities at CROs including assay validation, sample analysis and reporting
  • Contributing to Project Team activities by providing overviews, strategic planning and expert advice related to pharmacokinetic topics and tasks

Qualifications:

  • PhD or advanced degree in Life Sciences (e.g. pharmacokinetics, drug metabolism, biochemistry,  pharmaceutical sciences, or related)
  • A minimum of 8+ year’s relevant experience in the field, with a minimum of 5 years industry experience. In-depth knowledge of pharmacokinetics, clinical pharmacology (including drug metabolism and PK/PD evaluation) and familiarity with standard ADME/PK modelling tools
  • Significant experience designing, interpreting, and reporting nonclinical and clinical pharmacokinetic and PKPD modeling studies required to support regulatory submissions
  • Experience in authoring regulatory documents with knowledge of global regulatory requirements and the relevant guidance documents
  • Must have excellent writing and communication skills, attention to detail, and strong problem-solving skills, as well as the ability to work in a multidisciplinary team environment
  • Experience in working in project teams
  • Understanding of GXP compliance and ICH guidelines

Medical Science Liaison (East Coast)

Job Summary:

Responsible for co-developing and managing Viracta’s relationship with the medical/scientific community, including physicians and medical centers, by serving as a liaison to facilitate an active exchange related to our clinical development programs.

Duties/Responsibilities:

  • Establish, develop, and maintain relationships with Clinical Research Investigators, medical experts and KOLs in the hematology and oncology therapeutic areas.
  • Serve as a liaison to Research Centers and Key Opinion Leaders (KOLs) throughout the assigned region, providing field-based insights related to e.g., patient enrollment, study execution or therapeutic pathways to the study team members.
  • Establish and maintain strong collaborations with Investigators (PIs) and clinical trial sites to assist in supporting the enrollment and conduction of clinical studies
  • Provide medical/scientific training on clinical trial material (e.g., study protocols) to investigators and study staff
  • Assist with identifying new treatment centers, investigators, and referral networks for clinical trials
  • Partner cross-functionally with in-house and other customer facing staff towards achievement of strategic objectives
  • Work in accordance with applicable compliance laws in USA, including but not limited to the Sunshine Act.
  • Acting liaison to coordinate between stakeholders and trial sites to understand and effectively implement study protocols
  • Acts as educational support and scientific expert for internal and external requests on medical information related to Viracta clinical programs
  • Proactively engages with the HCP community and provides medical education as permissible by laws and regulations

Qualifications:

  • Advanced degree in life sciences (PhD or master’s degree preferred) with experience in biotech/ pharmaceutical industry
  • At least 4-5 years’ experience as an MSL with previous experience in Hematology-Oncology
  • Experience with KOL development, scientific communication, disease-specific educational programs, local advisory board management, and working within major academic centers.
  • Ability to comprehend, synthesize and communicate scientific concepts and data, with strong analytical skills.
  • Demonstrated ability to communicate effectively with KOLs, investigators and other site-based scientific experts (e.g., pathologists), study coordinators etc.
  • Knowledge of clinical operations, GCP, clinical trial design and study management
  • Excellent communicator with strong presentation skills
  • Thorough knowledge of relevant laws, regulations, and applicable compliance guidelines in USA, for example the Sunshine Act.
  • Resourceful, inquisitive, able to work autonomously and efficiently manage own calendar
  • Customer-focused
  • A valid US Driver's License
  • The position requires approximately 60-80% travel in USA, occasional travel to Europe may also be required.

Medical Science Liaison (West Coast)

Job Summary:

Responsible for co-developing and managing Viracta’s relationship with the medical/scientific community, including physicians and medical centers, by serving as a liaison to facilitate an active exchange related to our clinical development programs.

Duties/Responsibilities:

  • Establish, develop, and maintain relationships with Clinical Research Investigators, medical experts and KOLs in the hematology and oncology therapeutic areas.
  • Serve as a liaison to Research Centers and Key Opinion Leaders (KOLs) throughout the assigned region, providing field-based insights related to e.g., patient enrollment, study execution or therapeutic pathways to the study team members.
  • Establish and maintain strong collaborations with Investigators (PIs) and clinical trial sites to assist in supporting the enrollment and conduction of clinical studies
  • Provide medical/scientific training on clinical trial material (e.g., study protocols) to investigators and study staff
  • Assist with identifying new treatment centers, investigators, and referral networks for clinical trials
  • Partner cross-functionally with in-house and other customer facing staff towards achievement of strategic objectives
  • Work in accordance with applicable compliance laws in USA, including but not limited to the Sunshine Act.
  • Acting liaison to coordinate between stakeholders and trial sites to understand and effectively implement study protocols
  • Acts as educational support and scientific expert for internal and external requests on medical information related to Viracta clinical programs
  • Proactively engages with the HCP community and provides medical education as permissible by laws and regulations

Qualifications:

  • Advanced degree in life sciences (PhD or master’s degree preferred) with experience in biotech/ pharmaceutical industry
  • At least 4-5 years’ experience as an MSL with previous experience in Hematology-Oncology
  • Experience with KOL development, scientific communication, disease-specific educational programs, local advisory board management, and working within major academic centers.
  • Ability to comprehend, synthesize and communicate scientific concepts and data, with strong analytical skills.
  • Demonstrated ability to communicate effectively with KOLs, investigators and other site-based scientific experts (e.g., pathologists), study coordinators etc.
  • Knowledge of clinical operations, GCP, clinical trial design and study management
  • Excellent communicator with strong presentation skills
  • Thorough knowledge of relevant laws, regulations, and applicable compliance guidelines in USA, for example the Sunshine Act.
  • Resourceful, inquisitive, able to work autonomously and efficiently manage own calendar
  • Customer-focused
  • A valid US Driver's License
  • The position requires approximately 60-80% travel in USA, occasional travel to Europe may also be required.

Senior Associate/Manager Regulatory Affairs

Job Summary

We are currently seeking a Sr. Associate/Manager, Regulatory Affairs to join our experienced drug development team in Cardiff, CA. This individual will oversee day to day regulatory activities for assigned clinical programs and provide oversight to relevant CROs and consultants in conjunction with the regulatory leadership. A strong team player who enjoys oncology drug development and can communicate and collaborate in an interdisciplinary environment is essential.

Primary responsibilities of this position include:

  • Assist with the coordination, review and preparation of clinical trial applications and amendments, ensuring compliance with the Food and Drug Administration (FDA) and international regulations and interpretations.
  • Represent Regulatory Affairs on Study Management Teams for the clinical development and clinical trials of investigational new products.
  • Review and approve documentation (ICHE6 Essential Documents) required for release of clinical supplies to clinical sites.
  • Coordinate regulatory sections and review IND annual reports/ DSURs to ensure compliance with the Food and Drug Administration (FDA) and international regulations and interpretations.
  • Support the regulatory strategy, coordination, preparation, and submission of regulatory documents such as HA responses, pre meeting briefing packages, and CTD dossiers for HA approval Alert the Regulatory Management to issues and potential problems, delays and/or deficiencies, and make recommendations as appropriate.
  • Coordinate with the electronic submissions vendor to ensure timely and accurate delivery of all FDA submissions on time and of high-quality standards.
  • Maintain and index the regulatory archive (FDA and other international health authority submissions and correspondence)
  • Support development and implementation of regulatory strategies and guidance based on U.S. and International requirements
  • Schedule, track project/operational activities, such as labeling reviews and approvals.
  • Monitor various regulatory agency websites for new regulations, guidance documents and pertinent agency meetings.
  • Prepare Regulatory Standard Operating Procedures and Work Procedures
  • Perform other duties as assigned.

Qualifications:

  • Knowledge of FDA regulations. 
  • Knowledge of foreign regulations and ICH.
  • Understanding of Clinical Operations and drug development
  • Experience in the preparation and submission of INDs, CTAs, and amendments.
  • Able to review routine regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
  • Ability to prioritize multiple tasks.
  • Attention to detail.
  • PC literacy required; Proficient use of technology including MSOffice skills (Outlook, Word, Excel, PowerPoint, Montrium EDMS, and Internet resources)
  • Excellent verbal and written skills
  • Must be able to work successfully within a cross-functional team/partnership environment and as an individual contributor, with a high level of professionalism.
  • Bachelor's degree in a scientific discipline is preferred.

Required Education:

  • BS or advanced degree in physical or life sciences preferred

Area(s) of expertise desired:

  • 5+ years of relevant experience in pharmaceutical or biotechnology industry environment, of which 2-3 years of experience within Regulatory Affairs is highly desirable.

Clinical Trial Manager

Job Summary:

The Clinical Trial Manager is responsible for the timely execution of clinical studies by directing site feasibility, pre-qualification, site initiation, routine monitoring and study close out activities. The CTM ensures compliance with SOP’s and Good Clinical Practice; Oversees and manages CRO’s, study contractors and vendors; Coordinates training of junior staff involved in clinical trial management and identifies, mitigates, and escalates risks and issues.

Duties/Responsibilities:

  • Assist in the preparation and finalization of project and study-related documents including informed consent forms, pharmacy/lab manual, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required.
  • Ensure study documents are updated as needed throughout the trial.
  • Participate in the selection of clinical investigators and clinical study sites.
  • Responsible for responding to clinical study site and study related issues and recommending corrective actions and/or escalating to supervisor.
  • Oversee management of TMF, ongoing quality review and final reconciliation.
  • Coordinate the design, format, and content of CRFs, study guides, study reference binders, patient diaries, and study logs/forms including participating in the EDC and IVRS specification process and user acceptance testing.
  • Ensure that CRF data queries are resolved appropriately.
  • Coordinate and manage Investigational Product including shipment logistics, overall accountability and reconciliation.
  • Coordinates the preparation of clinical site budgets.
  • Manage project timelines and vendor performance to meet departmental and corporate goals.
  • Manage payment process (i.e., study site invoices, field monitor invoices, etc.) for all clinical trial study sites and field monitors, and/or vendors.
  • Monitor and track clinical trial progress and provide status update reports and study metrics.
  • Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, imaging, central ECG, etc.).
  • Responsible for selection of CRO study staff and coordinating training including documentation.
  • Manages the training and oversees study contract field monitors (e.g., review of all trip reports) and provide guidance on clinical study site issues.
  • Lead with minimal supervision in the planning of investigator meetings and making presentations, as required.
  • Lead with minimal supervision in the review of clinical data at the CRF, data listing, and report table levels.
  • Attend and/or participate in Site Initiation Visits (SIVs) and or Investigator Meetings as required.
  • Co-Monitoring with field monitor(s) for adherence to protocol and GCP as required.
  • Ensure all trip reports are reviewed and all action items are followed up per SOPs and work instructions.
  • Identify and escalate site, vendor and study-related issues to supervisor, as appropriate.
  • Assist with Department compliance initiatives and SOP writing when opportunity arises.
  • Support Internal and Health Authority inspections and audits as required, including driving inspection/audit readiness through life of the study.

Qualifications

  • This position requires a minimum of 8 years of experience in the pharmaceutical/clinical research environment with at least 4 years of study management, preferably in oncology.
  • Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
  • Knowledge of study tools including electronic system, such as CTMS, EDC, IRT, and eTMFs.
  • People Management is a plus.
  • Ability to exercise independent judgment.
  • Good organization and planning skills.
  • Strong interpersonal skills and communication skills (both written and oral).
  • Excellent comprehension of Good Clinical Practices and basic concepts of clinical research.
  • Must be willing to travel at least 25%-35% of the time.

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.