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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 



Principal Clinical Research Associate

Functional Area: Clinical Operations
Job Type: Full Time
Location: San Diego based but remote work will be considered

ABOUT VIRACTA THERAPEUTICS:

Viracta Therapeutics is private biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We will also expand into additional applications to utilize this approach for a range of cancers and virus-associated diseases.

POSITION DESCRIPTION:

Viracta is seeking a Principal Clinical Research Associate (Principal CRA) to support both ongoing and upcoming Oncology clinical trials. The position will provide a key role in contributing to the oversight of the clinical monitoring function across trials, including CRO monitoring oversight, developing and implementing best practices, and conducting and facilitate data monitoring and cleaning to ensure consistency and quality. The ideal candidate will have extensive experience as a senior CRA in lymphoma clinical trials and the ability to interact effectively with investigators and cross-functional teams. This position reports to the VP, Operations & Strategic Alliances.

KEY RESPONSIBILITIES:

  • Ensures timely and accurate study-related communication to internal and external study teams.
  • Provides oversight CRO monitoring activities to ensure quality and regulatory compliance
  • Assists with the review and creation of study-specific protocols, CRFs, manuals, tools, and templates, etc.
  • Ensures the investigators adhere to the established clinical protocols, regulatory requirements, and Good Clinical Practice, and provides input into data validation.
  • Attends and conducts site visits, primarily to provide CRO/contractor oversight and Sponsor level site engagement
  • Conducts on-site and remote monitoring to ensure consistency and quality across studies and to support achievement of company timelines, as needed.
  • Assists with the development and implementation of site-specific recruitment plans.
  • Assists with site feasibility, qualification, and selection process; conducts site monitoring visits, manages study monitoring schedule in collaboration with the CRO, audits CRFs for conformity to source documentation, assess and improve monitoring performance of CRO.
  • Sets data entry and monitoring related target timelines and oversees adherence to timelines.
  • Manages and helps create monitoring and site management related clinical trial tracking metrics and reporting for internal and external collaborators.
  • Participates in selection and management/oversight of external vendors and assists in developments of vendor specifications.

QUALIFICATIONS:

  • Bachelor’s degree in Biology, Biochemistry or other life science field of study; or an LVN, RN, PA, or other licensed health care professional degree.
  • Minimum 5 years of experience directly supporting oncology clinical research trials with a pharmaceutical company or CRO.
  • Experience in global lymphoma clinical trials, preferably in lead CRA or similar role
  • Ability to travel up to 20% of time to clinical sites.

Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives.

Drug Safety Manager

Functional Area: Safety/Clinical Operations
Job Type: Full Time, office based (Cardiff, CA); Remote may be considered
Required education: BS or advanced degree in physical or life sciences preferred
Area(s) of expertise desired: 3+ years of relevant experience in pharmaceutical or biotechnology industry environment. Relevant global safety reporting experience in oncology and training in GCP/GVP.

ABOUT VIRACTA THERAPEUTICS:

Viracta Therapeutics is private biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We will also expand into additional applications to utilize this approach for a range of cancers and virus-associated diseases.

POSITION DESCRIPTION:

We are currently seeking a Drug Safety Manager to join our experienced drug development team in Cardiff, CA. Remote candidates may be considered, however, in-house is preferred. He/she will oversee day to day safety and pharmacovigilance activity and contribute to the overall strategy for the organization and/or assigned clinical programs. This team member will provide oversight to relevant CROs and consultants in conjunction with the clinical development leadership. We are seeking a strong team player with experience in oncology drug development, strong communication skills, and ability to contribute to a collaborative interdisciplinary environment.

KEY RESPONSIBILITIES:

  • Ensure timely safety reporting to regulatory authorities, Independent Review Boards/Ethics Committees and Investigators in Viracta’s clinical trials
  • Support preparation for, participating in and ensuring adequate follow-up of safety/pharmacovigilance related audits and inspections.
  • Ensure close collaboration and communication with PV vendors on outsourced PV tasks
  • Design and review of Safety Management Plans for each ongoing clinical study to ensure compliance with relevant regulations
  • Maintain internal SAE and PV Master tracker and review e.g. safety CRO compliance reports
  • Review and give input to key study, regulatory and other documents (including but not limited to clinical study protocol and amendments, IBs, master patient information/informed consent forms and clinical study reports)

QUALIFICATIONS:

  • BS or advanced degree preferred in related field
  • Global experience in oncology
  • Superior writing skills.
  • Understanding of GXP (GCP and CVP) compliance and ICH guidelines
  • Strong computer capabilities, including MS Office and role relevant software systems (e.g. Argus)
  • Strong communication skills and an ability to work effectively with a diverse team of co-workers in a dynamic environment

Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives.

VP/Senior Director, Investor Relations & Corporate Communications

Viracta Therapeutics is public biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We will also expand into additional applications to utilize this approach for a range of cancers and virus-associated diseases.

JOB SUMMARY

Viracta Therapeutics is seeking an experienced VP/Senior Director, Investor Relations & Corporate Communications to plan and execute Viracta investor relations and corporate communications initiatives to assure the Company is well positioned with investors and media as well as aligned with Company goals and strategies. This position reports to the COO/CFO and will involve significant interaction with the executive leadership team.

KEY RESPONSIBILITIES

LEAD INVESTOR RELATIONS STRATEGY:

  • Develop strategies and programs to keep the financial community current on company performance, goals and industry dynamics.
  • Maintain existing IR presentation materials and develop new materials as needed.
  • Track and maintain a record of sell-side analysts’ coverage including estimates, ratings, reports and other relevant data.
  • Develop and produce reports and presentations on the company’s shareholders for senior management and the Board of Directors.
  • Interact with management at client companies to help create, plan and execute investor relations programs that can effectively generate interest and deliver messages to financial audiences, including KOL calls, analyst days, etc.
  • Draft and edit investor relations communications materials including press releases, conference call scripts, Fact Sheets in order to achieve communication plan objectives.
  • Participate in the quarterly reporting process, including calls with management, drafting earnings releases, conference call scripts and Q&A documents.
  • Write and manage content for corporate website.
  • Manage social media efforts, as it relates to investor relations.
  • Attend investor conferences and accompany client management on roadshows with institutional investors and sell side analysts.

LEAD CORPORATE COMMUNICATIONS OPERATIONS:

  • Lead the development and execution of the public relations strategy to advance the business’ strategic objectives with key audiences.
  • Collaborate with internal teams to identify opportunities to generate trade coverage surrounding key scientific publications and presentations.
  • Cultivate relationships with media contacts to generate interest in key industry news and research/recommend PR opportunities.
  • Lead the development of original content to support the company’s content strategy, including videos, written testimonials, byline articles, case studies, and social content.
  • Monitor media and social media for relevant stories and provide timely recommendations on potential media response from the company.
  • Develop and maintain local/regional media, national and trade media lists and maintain PR support tools (PR database(s), media monitoring/clipping services, etc.).
  • Maintain tracker of relevant original/organic coverage and generate reports to communicate results/effectiveness of PR efforts.
  • Support additional PR projects and campaigns as assigned.
  • Support other internal and external communication projects/plans as assigned.

QUALIFICATIONS

  • Bachelor’s degree in Business, Marketing, Communications or related field.
  • 8 to 10 years of corporate communication experience, including investor relations and public relations communications.
  • Experience launching, leading and measuring internal and external communication programs in a healthcare, biotech or drug development organization is required.
  • Experience with media relations, managing outside agencies to optimize productivity, and overseeing corporate web site and intranet.
  • Strong knowledge of capital markets and related constituents is required.
  • Outstanding verbal and written communication skills.
  • Ability to comprehend and communicate complex subjects.

Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives.

Director/Sr. Director, Chemical Development & API Manufacturing

Viracta Therapeutics is a rapid growing, public biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We are also expanding into additional applications to utilize this approach for a range of cancers and virus-associated diseases.

Position Description:

We are currently seeking a Director/Sr. Director, chemical development & API manufacturing to join our experienced drug development team in Cardiff, CA. This individual will lead the drug substance development and manufacturing efforts from pre-clinical development, through all clinical phases to commercialization. Close and frequent interactions with CMO’s external partners as well internal functional areas are expected. A strong team player who enjoys oncology drug development and has the ability to communicate and collaborate in an interdisciplinary environment is essential. Incumbent will report to the VP, Pharmaceutical Development.

Key Responsibilities:

  • Develop and implement the drug substance manufacturing and regulatory strategy for all Viracta drug candidates.
  • Design and develop chemistry process of starting materials, key intermediates, and drug candidates from gram to commercial scales.
  • Develop a supply chain for starting materials and drug candidates to appropriately support development program at various stages.
  • Oversee sourcing or synthesis development and production of starting materials, intermediates and analytical standards from tox to commercial bathes.
  • Conduct vendor selection, contract negotiation with external partners and manage relations with contract manufacturing organizations (CMOs).
  • Select key suppliers and guide CMOs through process development, optimizations, technology transfer, qualifications, validations and troubleshooting. Review and approve all technical documentation, i.e. protocols, reports, batch records. Be on-site, as needed.
  • Lead activities and provide supervision and guidance to CMOs to deliver robust, scalable, and cost-effective API manufacturing processes that meet the clinical and commercial needs.
  • Establish and assure adherence to high scientific and GMP standards within the drug substance production. Lead the API manufacturing function to successful completion of project deliverables.
  • Author and/or review relevant CMC sections of regulatory submissions (i.e., IMPD/IND/NDA) and responses to regulatory agency (i.e., FDA, EMA, etc.) inquiries.
  • Assure suitable forecasts of API needs for the clinical program and commercialization to ensure uninterrupted API supply.
  • Work with Regulatory, Quality and senior management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations.

Qualifications:

  • PhD or equivalent in a relevant discipline [Process Chemistry, Organic Chemistry, or related scientific discipline].
  • A minimum of 10 years of industry experience spanning development, scale-up and API manufacturing. Late-stage development experience is highly desired.
  • Hands on experience with managing API manufacturing & cGMP production
  • Experience in planning commercial supplies is highly desired.
  • Excellent leadership skills, leading drug product development function and development programs.
  • Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing API process development and manufacturing, stability, QC, QA etc.
  • Effective troubleshooting and problem-solving skills.
  • Demonstrated ability to work effectively in a fast-paced, team-oriented environment.
  • Strong individual contributor, flexible and able to handle multiple tasks in parallel and under tight timelines
  • Excellent communication skills (interpersonal, written and verbal), and management skills to collaborate with and direct the work of others on assigned projects.

Viracta Therapeutics is an Equal Opportunity Employer.