About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Organizational Marketing Statement
the company Vaccine Research & Development (VRD) organization is a recognized leader in the end to end development of vaccines and is responsible and accountable for activities from research to clinical development with a focus on the prevention and treatment of high medical-need diseases, delivering innovation that results in breakthrough therapies for patients and contributes significant value to the company enterprise. VRD priorities are focused on "high medical need, high-value" infectious disease targets for each life segment and active immuno-oncology (cancer vaccine) targets aligned with the company oncology research and business units. As one of the strategic pillars of VRD, the Vaccine Immunotherapeutics (VITx) group is primarily focused on cancer vaccine approaches based on active immunization and oncolytic virus based platforms that include combinations with other immunotherapeutic agents, for treating various cancers with the aim of increasing both response rates and duration of response along with improved safety profiles as compared with other passive immunotherapy or chemotherapy approaches.
As the head of Immuno-oncology group (~ 35 colleagues) and reporting to the VITx CSO, the role will have both a strategic and operational focus that includes:
• Direct leadership of the Translational Immuno-oncology, Immunology, and Clinical Cell Based Assay groups in providing discipline strategies and operational excellence.
• In partnership with the VITx CSO oversee programs in the delivery of preclinical and clinical milestones for the active immuno-oncology assets.
• In partnership with the VITx CSO and Head of VRD provides strategic and operational oversight to deliver on program goals and timelines. Develop strong collaborative leadership with Partner Lines (Oncology Research Unit, Oncology Clinical Research, Regulatory, Drug Safety, Pharmaceutical Sciences, Commercial) using previously demonstrated regulatory and clinical development experience to achieve phase 2 proof of concept.
• Apply expertise in oncology and immunology to active immuno-oncology platforms and use that understanding to create, assess and select novel active immunotherapeutic combination clinical candidates.
• Apply research capabilities, technologies and expertise necessary to build robust translational data packages that support the rationale for active immunotherapy combinations to be advanced into the clinic and/or acquire the necessary capabilities.
• Oversee within the infrastructure of VRD clinical cell based assays to quantify and phenotype immune responses that measure responses for our active immunotherapy platform assets in the clinic and strengthen collaborations across VRD and oncology RU clinical assay platforms and
• Strengthen research in oncology translational immunophenotyping and efficacy biomarker capabilities in VITx to more accurately measure immune responses to the various components of our active immunotherapy platforms such that clinical immunophenotyping data can be used to inform the selection of future combinations of platforms and immunomodulators.
• Build and leverage strategic and operational partnerships in immuno-oncology asset management, clinical study design, clinical immunophenotyping and outcome biomarkers with the Oncology Research Unit, Oncology Clinical Research and the company Oncology groups.
• Member of the VITx leadership team tasked with managing project teams comprised of matrixed resource from VITx's Translational Immuno-oncology group, ImmunoPharmacology, Immunology, Molecular Cell Biology and Protein Biochemistry, and Formulation and Analytical groups.
Leadership of the Immuno-oncology Group
• Advises VRD leadership on the strategy and execution of active immune oncology approaches
- Directs the strategic and operational activities for Immunology, Translational Immunology and Clinical Cell Based Assay groups.
• Management and career development of colleagues in these groups with focus on high potential colleagues.
• Oversees the Clinical Cell Based Assay group to implement centralized GCLP-like assays required for evaluation of both immune responses and efficacy biomarkers to the VBIR and OBIR programs being assessed in clinical studies
• Develops strategy and ensure operational excellence in implementing SOPs for immunophenotyping and clinical efficacy biomarkers (cfDNA, CTC, tumor antigens)
• Accountable for maintaining a safe working environment of the Group colleagues compliant with all the company EHS and California specific EHS polices. Also accountable for site specific goals for waste reduction and energy minimization.
Accountable for design and execution of Immunotherapeutic program's regulatory and clinical strategy that gains endorsement from the VRD leadership team and/or from the WRD LT
• Assuming Program Lead responsibilities, work with Partner Lines, Oncology Clinical Research, and Commercial to create a strategy and 'full line of sight' plan from inception to end which reflects realistic and detailed operational planning
• Responsible for forming and leading high performance matrix Program Teams that utilises member expertise to identify and solve problems in the Regulatory, Drug Safety, Clinical, Development Operations and Pharmaceutical Science areas such that program objectives are met
• Responsible for preparing documentation for internal governance, compliance and regulatory submissions such as INDs
• Provide updates and seek endorsement for strategies and plans from CSO of VITx and Head of VRD as appropriate
Member of the VITx leadership team to oversee the prosecution of the VITx portfolio of programs
• As a member of the VITx LT, evaluate and endorse research plans for the evaluation of active immunotherapeutic platform and immunomodulator combinations. Apply professional judgement in endorsing robust and fit-for-purpose testing cascades for experimental approaches and efficacy measures that provide increased translational confidence.
• As a member of the VITx LT co-own the project and program portfolio and be accountable for delivery of VITx goals to VRD
• As a member of the VITx LT, evaluate and prioritise project studies so as to effectively manage the matrix application of VITx resource in La Jolla
• As a member of the VITx LT appropriately apply capital and manage talent across VITx, and act as a mentor and coach of High Potential colleagues
Communication and documentation
• Responsible for regular 1:1 communication with the VITx and VRD management, VITx colleagues, partner lines and Oncology Area colleagues
• Grow strategic and operational liaisons with the Oncology Research Unit, Oncology Clinical Research and the company Oncology Groups.
• Represent the company at scientific events, and present and publish in the broader scientific community
• Present strategy and progress as appropriate to the company management
• Responsible for sign-off of SOPs, study reports and protocols
• Ensure that the Immunology, Translational Immunology and Clinical Cell Based Assay colleagues are current with electronic laboratory notebook entries and are in full compliance with the company IP policy and GSP
• MD/PhD or PhD in immunology, Immuno-oncology, cancer biology or relevant biological science
• At least 12 years of experience in immuno-oncology drug discovery and development, with a focus and understanding of immune response mechanisms to active immunotherapy when used with immunomodulators. The candidate should have advanced understanding and experience with translational research for both quantifying and identifying immune responses to various active and passive immunotherapies measurable in early clinical studies
• Established presence in immuno oncology field with a strong record of immuno-oncology product development experience (in biotech or pharma) exemplified through the oversight and/or generation of ND submissions, clinical trial design and early stage execution.
• A record of publishing in immunology and or cancer biology with emphasis on translational immuno-oncology
• Strong scientific leadership experience, combined with experience of leading multi-disciplinary discovery project teams and excellent communication skills
• Proven line lead experience in attracting and developing high potential colleagues and providing both lateral and expanded role opportunities
• Ability to build cross functional relationship in order to support effective and efficient utilization of WRD resources to support the active immune oncology portfolio
Normal physical/mental requirements for office-based scientific role
Non-standard Work Schedule, Travel or Environment Requirements:
US travel (up to 25% time) expected as part of this role
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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