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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. To apply, please submit your resume to humanresources@viracta.com and include the job title in the subject line. No recruiters please.

Vice President, Business Development & Corporate Strategy

Functional Area: Business Development
Job Type: Full Time

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 Vice President, Business Development & Corporate Strategy, to join our experienced  team in Cardiff, CA. The Vice President, Business Development & Corporate Strategy, will lead Viracta’s corporate strategic planning process for both short and long-term objectives, establish and execute on a disciplined and focused search and evaluation strategy, manage and facilitate all outbound strategic and business development interactions, manage early and pre-launch commercial planning, and development of financial valuation models.  The position includes identification, pursuit, and assisting in the management of potential merger and acquisition opportunities, partnerships, alliances, joint ventures, and licensing agreements.

KEY RESPONSIBILITIES:

  • Lead and manage a cross-functional team to develop and evolve Viracta Therapeutics’ strategic plan (including the strategic program life cycle management, business development plan, etc) and partner closely with the Company’s Executive leadership team to implement strategy.
  • Lead cross-functional teams to identify, evaluate, and diligence in/out licensing opportunities, strategic alliance/partnerships, collaborations and potential mergers/acquisitions.
  • Develop strong external relationships with counterparts, author Term Sheets, develop and lead presentations and meetings with prospective partners, analyze and provide recommendations concerning all contemplated transactions, negotiate and execute all Board-approved transactions.
  • Plan, conduct and internally communicate early and pre-launch commercial planning activities appropriate to program/product stage of development, including competitive intelligence, therapeutic indication prioritization, development of product target product profiles, and primary and secondary market research.
  • Utilize new product planning to provide researched recommendations on therapeutic drug programs from preclinical through clinical stages.
  • Utilizing data from above categories, build robust financial models for individual programs and the Viracta Therapeutics’ portfolio as a whole, including risk analysis.
  • Utilize valuation models to develop terms, inform business development negotiations and provide guidance to executive management on appropriate investment levels to optimize business development and market outcomes.

QUALIFICATIONS

  • Bachelor’s Degree, preferably in biological sciences with advanced degree desirable. A combination of relevant education and applicable job experience may be considered.
  • 10+ years previous experience in a biotech or pharmaceutical company or strategic consulting firm.
  • Oncology experience is highly desirable.
  • A proven track record of successfully negotiating and closing a variety of corporate transactions and business agreements, such as strategic alliances, M&A transactions, and licensing agreements; established and active business/corporate development relationships/contacts within pharmaceutical industry.
  • Ability to identify potential new opportunities through a strong knowledge of market and competitive environments.
  • A thorough understanding of the process of due diligence and asset valuation combined with a scientific and business acumen.
  • Critical thinking skills with the ability to get to the right level of granularity to balance speed of execution and facilitate optimal decision-making by executive management.
  • Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
  • Strong understanding of key functions and their roles throughout stages of drug development.
  • Experience managing external collaborations or relationships.
  • Superior quantitative, analytic, research and financial modeling skills along with the ability to translate analyses into sound strategic recommendations.
  • Ability to work in a results-oriented, project-driven, real-time team environment, prioritize projects and deliver quality results within tight time constraints.


Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to humanresources@viracta.com and include the job title in the subject line. No recruiters please.

Medical Director

Position Title: Medical Director
Functional Area: Clinical Development
Job Type: Full Time
Required qualifications: MD with 5-8 years' experience in clinical research or drug development. Specialization in oncology, hematology or internal medicine is a plus.

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 full time Medical Director to join our experienced drug development team in Cardiff, CA. The Medical Director will be responsible for providing medical/disease area expertise into various aspects of the clinical development program, and for the timely execution of our clinical trials together with the clinical operations team. We are seeking a strong team player with excellent communication skills, and the ability to contribute to a collaborative interdisciplinary environment.

KEY RESPONSIBILITIES:

  • Contribute scientific and strategic input to the development and execution of the clinical programs.
  • Build relationships within the clinical/scientific community and with external experts.
  • Provide clinical expertise to support other departments (e.g. for target evaluation, discovery, etc).
  • Develop clinical trial protocols, study reports and other documents.
  • Contribute medical /scientific input to clinical strategy and Regulatory documents (Investigator’s Brochure, IND annual report, Health Authority briefing books and submissions, etc).
  • Drive the execution of clinical trials with the clinical operations team (including selection of investigators/study sites, patient enrollment).
  • Maintain oversight of drug safety and safety monitoring in clinical trials.
  • Review and approval of study documents throughout the clinical trial course: feasibility questionnaires, pre-study/initiation/monitoring/close-out visit reports, statistical analysis plans, AE reconciliation reports, etc.

QUALIFICATIONS:

  • Degree in Medicine, with 5-8 years' experience in clinical research or drug development. Specialization in oncology, hematology or internal medicine is a plus.
  • Excellent analytical abilities, together with presentation and communication skills
  • Familiar with all aspects of the clinical development process.
  • Proven ability to interpret efficacy and safety data relating to assigned area.
  • Medical-Scientific writing skills.
  • Knowledge of GCP
  • Strong collaboration and problem-solving skills
  • Active, dynamic and a team player


Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to humanresources@viracta.com and include the job title in the subject line. No recruiters please.

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. To apply, please submit your resume to humanresources@viracta.com and include the job title in the subject line

Senior Director, Formulation Development & Manufacturing

Position Title: Senior Director, Formulation Development & Manufacturing
Functional Area: CMC operation

ABOUT VIRACTA THERAPEUTICS:

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 Senior Director, Formulation Development & Manufacturing to join our experienced drug development team in Cardiff, CA. The incumbent will lead formulation development/drug product manufacturing efforts and may represent the CMC function in the leadership team. Close and frequent interactions with 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. This position reports to the Chief Operating Officer.

KEY RESPONSIBILITIES:

  • Define technical drug product development strategy for all clinical programs.
  • Establish and assure adherence to high scientific standards within the CMC drug product function.
  • Lead the formulation development & drug product manufacturing function to successful completion of project deliverables.
  • Lead drug product development including oral solid dosage, fixed dosing combination and pediatric product via CDMO partners.
  • Oversee manufacturing, release, and global distribution of materials for the clinical studies.
  • Lead the team and provide supervision and guidance to deliver robust, scalable, and cost-effective product manufacturing processes that meet the clinical needs and future commercialization.
  • Conduct vendor selection and conduct contract negotiations with external partners.
  • Work with Regulatory, Quality and the senior management teams to ensure all company policies are adhered to and all external manufacturing activities comply with relevant regulations.
  • Author and/or review relevant CMC sections of regulatory submissions (i.e., IMPD/IND/NDA) and responses to regulatory agency (i.e., FDA, EMA) inquiries.
  • Assure suitable forecasts of API and DP needs for the clinical programs to ensure uninterrupted drug supply.
  • Manage and oversee clinical supplies.

QUALIFICATIONS:

  • PhD or equivalent in a relevant discipline such as Pharmaceutical Sciences, Organic Chemistry, or other scientific discipline.
  • 15+ years of industry experience spanning development, scale-up and manufacturing of small molecule drug products in the biotechnology or pharmaceutical industry.
  • Late-stage development experience is highly desired.
  • Hands on experience in formulation development and cGMP production of oral solid dosages. Experience on combination product and pediatric product formulation development is highly desired.
  • Experience with managing API manufacturing will be a plus.
  • Excellent leadership skills in leading drug product development function and development programs.
  • Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacturing, stability, QC, QA, etc.
  • Superb interpersonal, written and verbal communication skills to collaborate with and direct the work of others on assigned projects.
  • Demonstrated ability to work effectively in a fast-paced, team-oriented environment.

Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to humanresources@Viracta.