If you share our passion for advancing new medicines to benefit patients with virus-associated cancers and other serious diseases, please submit your resume.
Senior Director, Business Development
Responsibilities and Duties:
- Partner with the Senior Vice President, Business Development to successfully execute the Business Development strategy
- Conduct search and evaluation of in-licensing opportunities emanating from academia, VC, biotech and peer-pharma, including early research projects, new modality platforms, pre-clinical and clinical stage assets
- Manage day-to-day corporate and business development activities, lead internal team to identify and develop opportunities of highest interest/value, organize diligence activities, partner with external counsel, and participate in negotiations
- Collaborate with senior management, potential partners and/or target organizations; communicate in a manner that reflects positively on the company and our strategy and core values
- Partner with finance in the development of financial analysis and valuation models for potential corporate collaborations and partnerships
- Ensure that the company maintains a strong presence at key business development forums.
- Additional projects and responsibilities assigned by manager
Preferred and Required Qualifications and Skills:
- Bachelor’s degree required; MBA and/or PhD preferred
- A minimum of 10 years (bio) pharmaceutical industry experience including leadership experience in business development
- Must have oncology experience
- Creative thinking with the ability to translate corporate development goals into a business development strategy with appropriate tactics
- Experience in all aspects of business development and licensing including evaluation, due diligence, modeling, negotiating, and closing deals
- A strong understanding of drug development and commercialization
- A strong scientific background
- Experience working cross-functionally with R&D, clinical, finance, legal, CMC and commercial organizations to formulate business development strategy and drive competitive initiatives to successful conclusions
- The ability to move within a fast paced environment
- Excellent communicator and influencer with effective presentation skills
If you are interested in this position, please apply here.
Director Research and Development
Viracta Therapeutics, a precision oncology company focused on advancing new medicines for the treatment of virus-associated malignancies, is seeking a director level Research Scientist. The successful candidate will bring deep scientific and therapeutic area experience with regards to hematological and/or solid tumor biology, preclinical models of metastases, early clinical development, and experience managing external academic and industrial collaborations. Key candidate attributes include effective project level decision making, and effective communication within the department and with senior management.
This position reports to the CSO (Chief Scientific Officer) and will work with the Research team to ensure productive and successful completion of external collaboration in support of Viracta’s main clinical candidate Nana-val. In addition, the candidate will be a key part of the team that provides strategic, technical, and scientific leadership for next-generation asset development.
Responsibilities and Duties:
- Create and maintain integrated project plans supporting cross-functional drug development activities for high priority, early-stage program(s)
- Leverage strong project and organizational knowledge, leadership, and facilitation skills to optimize team meetings and facilitate effective governance and decision making
- Build and leverage relationships and networks to initiate and promote scientific collaborations
- Manage collaborations to ensure project scope, resources, timelines, and budget are efficiently met
- Provide scientific leadership in areas of asset evaluation for the expansion of the Viracta pipeline
- Propose and develop innovative methods and technologies for assessment of novel therapeutic activity on viral malignancies
- Identify pharmacodynamic assays for utility in pre-clinical and clinical setting; help define PK/PD/efficacy relationships
- Manage relationships and communications externally with collaborators, academic investigators and diverse CRO’s to execute pre-clinical research to identify potential new pathways and mechanisms of action
- PhD in immunobiology, cancer biology, virology, biochemistry, cell biology, pharmacology, or related field
- 5+ years of pharmaceutical or biotechnology industry experience in oncology/cancer immunotherapy
- Experience in leading successful preclinical studies supporting pre-IND filing
- Experience in cell and animal models of oncogenesis. Additional emphasis on Immune Profiling, small/or large molecule characterization, and studies delineating the mechanism of action
- Outstanding record of accomplishment of scientific achievement and excellent soft skills
- Excellent verbal and written communication and organizational skills with demonstrated success in leading projects and interacting with cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced, and evolving environment
If you are interested in this position, please apply here: Here
Associate Director of Regulatory Affairs
The Associate Director of Regulatory Affairs is responsible for developing and implementing global regulatory strategies to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product.
- Provides support for all phases of product development in the assigned portfolio and interfaces with R&D, Project Management, Quality, and Regulatory colleagues, as well as potential collaborations partners.
- Develops effective regulatory strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and is able to interpret and apply local regulations and guidance’s to the life cycle of a drug product. This includes review of changes in existing products to determine the need for new/revised submissions or document reason(s) why submission of the change is unnecessary.
- Regulatory experience in Oncology, therapeutic area, and experience in developing and implementing regulatory strategies for projects with a companion diagnostics highly desirable.
- Oversees document packages for regulatory submissions. This includes initial submission to Health Authorities (HAs), and preparation of responses to questions from HAs balancing HA requirements and corporate objectives.
- Manages timelines in cooperation with Project Management on assigned projects.
- Reviews sections of IND/CTA, NDA/MAA, and other global submissions to support clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
- Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to global (US, EU, and Japan) development projects and marketed product regulatory issues to support corporate goals.
- Ability to work with regulatory CROs to identify regional/country-specific Clinical, Nonclinical, and CMC requirements to support global applications.
- BS/BA Biochemistry, Biology, or Pharmaceutical Science at a minimum; advanced degree desirable.
- At least 9 years experience in the pharmaceutical industry and at least 5 of these years in a Regulatory capacity.
- Strong negotiation skills and significant experience in interacting with regulatory authorities (FDA, EMA).
- Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas.
- Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally, demonstrated success in negotiation skills, strategic thinking, strong verbal and written communication, leadership and be a credible business partner within the organization.
- Expert knowledge of US and international GCP regulations, current industry practices, and strong experience with interpretation and application to development projects and marketed product regulatory issues.
- Demonstrable experience in managing others.
If you are interested in this position, please apply: Here.