GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient's immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. GT BioPharma has an exciting and highly impactful opportunity available for a Director / Senior Director of Discovery Biology who will lead the biology research team, provide technical expertise, seek new opportunities for the TriKE® technology, and support the cross functional clinical development planning. Reporting to the Interim Chief Executive Officer, President, Research and Development and Chief Medical Officer, based in either the San Francisco Bay Area or Boston, Massachusetts area, the responsibilities of the Director / Senior Director are described below.
Primary Duties and Responsibilities
The successful candidate will bring a strong strategic mindset and will lead internal efforts and support outsourced external laboratory-based research activities aimed at characterizing novel and established immune based therapeutic targets for the treatment of oncology indications.
- Provides leadership capability to project/project team, creates and tracks achievable goals for the team that are aligned with Corporate Objectives, designs and carries out laboratory experiments for discovery, research and early development of immune-oncology projects.
- Develops scientific strategies, and accountable for project success and deliverables.
- Has direct impact on the performance of multiple departments through leading project teams and contributing to cross-functional teams.
- Provides in-depth analysis and interpretations of diverse experimental results.
- Independently designs and implements long-term project plans and appropriate experiments that define efficacy and mechanism of action of the TriKE® product via gene, protein and function-based in vitro assessments.
- Improves current functional assessment approaches by designing pertinent novel cell-based assays and/or cellular immune-based assays.
- Provide recommendations for and implement studies and strategies to define the phenotypic and functional characteristics of the TriKE® product in pertinent in vivo studies.
- Supervise contract research organizations to achieve high standards of productivity and quality.
- Present work at project team meetings, internal forums, and external meetings.
- Provide scientific progress reports to the Senior Management as required.
- Author and oversee writing of study reports, patents, and peer-reviewed publications. Presentation of methods, results, and conclusions to publishable standards.
- Prepare IND format documentation and / or reports based on scientific results as required.
- Manage projects to successful outcomes through scientific leadership, teamwork and influence, and potentially direct reporting relationships.
- Develops research staff through instruction, coaching and guidance.
- PhD or MD/PhD in a relevant field, Immune Cell Biology (such as NK cells, or T cells), Cellular and Molecular Immunology, and Molecular Biology, with post-doctoral/fellowship experience plus at least 5 years of relevant work experience are required.
- Advanced multi-parameter flow cytometry skills are required.
- Demonstrated expertise of a wide range of in vitro cellular and biochemical assays, including cell isolation and culture, molecular biology, cellular immunology assays and familiarity with in vivo models of immune disease or oncology are required.
- Track record of success as evidenced by a strong publication record, and/or, evidence of sustained contributions in the biopharmaceutical industry.
- Proven track record of scientific approach to complex problem solving, able to anticipate problems at project level and interpret contingency plans, identifies solutions and strategies, and implements appropriate scientific actions.
- Proven ability to derive novel insights from complex data.
- Comprehensive knowledge of cancer biology, target selection, target screening, immunotherapy, state of the art genetic engineering techniques in both cell lines and primary cell cultures, and mammalian expression vectors.
- Ability to interpret and summarize scientific data in an accurate, critical and concise manner.
- The individual is also expected to establish and manage productive collaborations with academic researchers and contribute to the scientific community by publishing results in high quality journals.
- Must work effectively in a matrix environment, qualities of scientific leadership are particularly sought.
- Must be a team player, able to collaborate across multidisciplinary teams, and also have the ability to work independently.
- Proven ability to produce invention disclosure and patent applications.
- Effective communication is essential and includes presentations to effectively convey scientific concepts and data among research scientists, management teams within internal working groups/project teams, external academic and industrial organizations, review committees, and conferences. Writing for clinical protocols, reports, regulatory filings, and scientific publications is also required.
- Ability to travel, on occasion, to Minneapolis Minnesota.
GT Biopharma is an equal opportunity employer, with an ongoing effort to foster diversity and inclusion in the workplace. Individuals seeking employment at GT Biopharma are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient's immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. GT BioPharma has an exciting and highly impactful opportunity available for a Vice President, Regulatory Affairs to build the oncology portfolio assets at GT BioPharma. This strategic leader will report into the President, Research and Development and Chief Medical Officer.
- Responsible for development, oversight, and communication of global regulatory strategy for assigned projects.
- Serves as a Core member of the cross-functional Project Team representing the global regulatory strategy for assigned global multi-indication projects.
- Leads Regulatory Project Team for assigned projects.
- Leads or manages leads of cross-functional/cross-regional Regulatory Submission Teams and participates on other sub teams. Oversees submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
- Accountable for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation and regulatory guidance is met for assigned product(s) and territories.
- Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidance, comments on draft regulatory guidance, and communicates changes in regulatory information to project teams and senior management.
- Science degree (PhD, PharmD, MD, MSc) with 12+ years; Bachelor’s degree with 15+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry to includeMarket Applications Submission experience (BLA/NDA/MAA) and experience developing and implementing regulatory strategy and managing complex negotiations with Regulatory Authorities.
- Demonstrated effective verbal, written, negotiation and interpersonal communication skills are required.
- Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and understand current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
- Proven track record with taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments.
- Prior experience leading one or more teams in preparation of submissions and maintenance of licenses.
- Recognized as an expert resource for Regulatory issues for other cross functional departments.
To qualify please email your CV to email@example.com.