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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.

Business/Legal Operations Manager

Summary/Job Purpose

Reporting to the Vice President of Portfolio Planning and Program Management and dotted line to the General Counsel; draft, negotiate and manage a variety of contracts/change orders, track budget and enable meeting planning supporting Viracta research, development, and other functions as needed; providing key support to advance Viracta mission to help cancer patients.

Essential Duties and Responsibilities

  • Contracts:
    • Draft, negotiate and manage a wide range of contracts and change orders (which may include confidentiality agreements, consulting and service agreements, materials transfer agreements, research agreements, clinical study agreements, and various vendor services agreements).
    • Implement selected contract management software.
    • Assist with contracts process improvement and CRO and other vendor relationship management.
    • Advise and troubleshoot on existing agreements and agreement-related questions.
    • Define risks related to contracts documents and relationships and be able to communicate those risks to appropriate internal decision-makers for discussion and resolution.
    • Interact with various internal clients efficiently and effectively to address legal and business questions.
    • Handle miscellaneous legal tasks on an as needed basis under the direction of the General Counsel.
    •  
  • Budget Tracking and Accruals:
    • Maintain and track status for contracts and change orders.
    • Enable renewal of consultant agreements.
    • Partner with departments and finance to monitor accruals for various contracts to take primary ownership of information flow from Clin/Ops/Reg to and from Finance.
    • Ensure vendor invoicing is appropriate and consistent with executed contracts and accepted budget(s).
    • Assist with business process improvement and implementation to address the gaps in the growth environment.
    • Key contact for clinical accruals, budget tracking and auditor queries.
  • Conference and Meeting Planning:
    • Assist with conference planning logistics for the team including but not limited to securing sponsorships, booths, materials, outsourcing booth build etc.
    • Assist in meeting planning for Investigator Meetings, KOL Meetings, etc.

Supervisory Responsibilities - No supervisory responsibilities.

Education/Experience/Knowledge & Skills:

  • BS/BA degree in related discipline and seven to ten years of related experience.
  • 7-10 years of related industry experience.
  • An equivalent combination of education and experience will be considered.

Experience/The Ideal Candidate Will Have

  • Seven to ten years of in-house experience at a biotechnology, pharmaceutical or med-tech company, with a focus on contract drafting and negotiation.
  • Experience with word processing, contracts management and outsourcing methodology, budget tracking and meeting planning needed.

Knowledge/Skills

  • Thorough understanding of the contract management and outsourcing process, including tracking, negotiation, approval, and signature processes.
  • Working knowledge of the drug discovery and development process and ability to understand risks and requirements associated with pharmaceutical contracting preferred.
  • Ability to work both independently and effectively across a variety of functional groups (such as Clinical, Research and Development, CMC, Human Resources, Finance, Facilities, and all levels of management.
  • Flexible and willing to learn new procedures and skill sets.
  • Experience with or knowledge of paralegal support tasks, with a focus on intellectual property matters or corporate matters, preferred. Clear and concise verbal and written communication skills; must have excellent interpersonal communication skills. Strong computer and tools skills (e.g., Microsoft Word, Excel, and PowerPoint).
  • Ability to see the need and address the gaps (with processes, expertise, engagement of key stakeholders etc.)
  • Must be detail oriented and have strong organizational skills.
  • Ability to handle multiple tasks simultaneously.
  • Ability to prioritize; must be responsible and conscientious.
  • Ability to work under pressure to meet specific deadlines.
  • Dedication to quality and reliability in all work tasks.
  • Ability to handle ambiguity and ask questions to drive towards solutions in a growing company.

Working Conditions

  • Environment: primarily working indoors, performing clerical work.
  • Remote will be considered.
  • 5% travel may be required for meeting coordination.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Manager, Regulatory Operations

The Role

The Manager of Regulatory Operations plays a vital role in our Regulatory Affairs team. This role provides document editing, formatting and publishing support to facilitate accurate and timely preparation of Word and PDF documents associated with non-clinical studies, clinical studies, and CMC documentation in support of global regulatory submissions conforming to the electronic Common Technical Document (eCTD) format, and other submission standards as specified by FDA, ICH, and ROW guidelines.

In addition, the Manager of Regulatory Operations will assist in the implementation, maintenance, and support of systems and processes used within the Regulatory Affairs team. This position reports to the Head of Regulatory Affairs. This position will not have direct reports but must be able to operate effectively in collaboration internally with cross-functional team members and externally with vendors and partners.

Primary Responsibilities

  • Coordinate and perform document editing, formatting, publication, and submittal of regulatory submissions as assigned by the Head of Regulatory Affairs.
  • Compile and perform hyperlinking of electronic submissions using associated publishing tools.
  • Ensure final document components are electronically archived according to departmental practices within RegDocs Connect Module (Regulatory EDMS) of the Montrium system.
  • Assist with regulatory submission tracking and planning within the Regulatory Navigator of Montrium.
  • Interface with Regulatory team members and appropriate functional staff regarding submission planning, document templates, and publishing.
  • Review source documents for use related to eCTD compliance and provide formatting suggestions to create eCTD-ready documents as needed.
  • Provide training, technical support, and coordination for Viracta team members, as necessary, throughout the process of creating eCTD-compliant PDF report compilations, including document troubleshooting and use of software and Accenture document templates.
  • Organize and track all documents designated for major and minor submissions.
  • Receive data, text, and proposed report templates from various sources and provide editing or reformatting, as needed to present information in a clear consistent style across documents.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

About you

Must Have/Required

  • 5+ years of electronic publishing-related experience, or an equivalent combination of education and experience.
  • Experience with publishing and submission of dossiers in eCTD and non-eCTD format.
  • Advanced computer skills, specifically in Microsoft Office Word, formatting and style templates, Adobe Acrobat and Montrium.
  • A superior multi-tasker, highly organized and successful in a fast paced, changing environment.
  • Proven history of reading and interpreting documents such as operating and maintenance instructions, software manuals, study documents, and procedure manuals.
  • Ability to follow complex direction/processes and solve complex problems under pressure.
  • A proven, independent worker with a successful history of managing product lifecycle.
  • A record of working effectively and cooperatively in a team environment under significant time pressure.
  • Demonstrated attention to detail and consistent ability to operate with accuracy and quality.
  • Excellent oral, written, and interpersonal skills; with a reputation for cultivating collaborations across departments and the whole organization.

May Have/Preferred

  • Experience in managing one or more direct reports.
  • Advanced knowledge of electronic document management systems (EDMS) and Regulatory Information Management Systems (RIMS), including Montrium
  • Experience with computer systems validation procedures, and the implementation and maintenance of Regulatory Information Systems and Processes
  • Leadership in training and educating other Regulatory team members in submission publishing concepts
  • Interfacing directly with technical contacts within FDA and other global health authorities
  • Experience with rare diseases and hematology/oncology
  • Experience in a small company and high growth, fast-paced environment

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.